ESCALOL 507

ETHYLHEXYL DIMETHYL PABA(ESCALOL 507,ETLHEKSL DMETL PABA)

CAS No.: 21245-02-3

EC No.: 244-289-3

Synonyms:

ETHYLHEXYL DIMETHYL PABA ; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 21245-02-3; 2-Ethylhexyl 4-(dimethylamino)benzoate; Padimate O; 2-ETHYLHEXYL 4-DIMETHYLAMINOBENZOATE; Escalol 507; Padimate-O; Octyl dimethyl PABA; Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester; Arlatone UVB; 2-Ethylhexyl p-dimethylaminobenzoate; 2-Ethylhexyl-4-dimethylaminobenzoate; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Eusolex 6007; 2-Ethylhexyl-p-dimethyl-aminobenzoate; Radiacare Lip Balm; 4-(Dimethylamino)benzoic acid 2-ethylhexyl ester; 2-Ethylhexyl p-(dimethylamino)benzoate; Octyl dimethyl p-aminobenzoate; Caraloe Snow & Sun Lip Balm; HSDB 7169; ETHYLHEXYL DIMETHYL PABA ; EINECS 244-289-3; NCGC00090764-02; DSSTox_CID_9320; DSSTox_RID_78762; Escalol 507; DSSTox_GSID_29320; 4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester; Benzoic acid, p-(dimethylamino)-, 2-ethylhexyl ester; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; CAS-21245-02-3; Octyl-Dimethyl-Paba; MFCD00017526; Padimate O (USP); FR-2108; Arlatone UVB (TN); Photoplex (Salt/Mix); PubChem20907; ACMC-1CD6X; ETHYLHEXYL DIMETHYL PABA ; Padimate o [USAN:USP]; PreSun 23 (Salt/Mix); Padimate O [USAN:BAN]; SCHEMBL15432; KSC490C3D; MLS001055379; ETHYLHEXYL DIMETHYL PABA; Padimate O, analytical standard; Radiacare Lip Balm (Salt/Mix); Escalol 507; Escalol 507; Escalol 507; Escalol 507; Escalol 507; Escalol 507; Escalol 507; CHEMBL1323699; DTXSID7029320; CTK3J0131; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; ETHYLHEXYL DIMETHYL PABA ; KS-00000ZQC; CHEBI:135932; HMS3039F10; Tox21_111013; Tox21_202421; Tox21_303574; ANW-24381; SBB008471; 2-ethylhexyl4-(dimethylamino)benzoate; AKOS015890282; Tox21_111013_1; 2-Ethylhexyl-4′-dimethylamino-benzoate; AM84740; DB11570; LS-2257; MCULE-7746500520; NCGC00090764-01; NCGC00090764-03; NCGC00090764-04; NCGC00257250-01; Escalol 507; Escalol 507; Escalol 507; Escalol 507; NCGC00259970-01; AC-13165; ACM212545023; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; AK-49567; CC-10519; L263; SC-17626; SMR000677935; Caraloe Snow & Sun Lip Balm (Salt/Mix); AX8017127; DB-021046; D1871; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; Escalol 507; Escalol 507; Escalol 507; Escalol 507; FT-0616757; NS00005726; NS00099022; ST50826077; 2-Ethylhexyl 4-(dimethylamino)benzoate, 98%; p-Dimethylaminobenzoic acid 2-ethylhexyl ester; D05335; C-17459; SR-01000864568; Q6628390; SR-01000864568-2; 2-Ethylhexyl 4-(dimethylamino)benzoate (Octyl Dimethyl PABA); Padimate O, United States Pharmacopeia (USP) Reference Standard; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Padimate O, Pharmaceutical Secondary Standard; ETHYLHEXYL DIMETHYL PABA ; Escalol 507; Escalol 507; Escalol 507; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; Certified Reference Material; 2-Ethylhexyl 4-(dimethylamino)benzoate;2-Ethylhexyl 4-(dimethylamino)benzoate (Octyl Dimethyl PABA);octyl-dimethyl-p-aminobenzoic acid;2-ethylhexyl 4-(dimethylamino)benzoate;2-ethyl-hexyl-4-dimethyl-aminobenzoate;ETHYLHEXYL DIMETHYL PABA; arlatone UVB; benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester; benzoic acid, p-(dimethylamino)-, 2-ethylhexyl ester; escalol 507; 2-ethyl hexyl 4-(dimethyl amino) benzoate; 2-ethylhexyl 4-(dimethylamino)benzoate; Escalol 507; Escalol 507; Escalol 507; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 2-ethylhexyl p-(dimethylamino)benzoate; 2-ethylhexyl p-dimethylaminobenzoate; eusolex 6007; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; octyl dimethyl p-aminobenzoate; octyl dimethyl paba; padimate O; 2-Ethylhexyl 4-(N ,N -dimethylamino)benzoate; 2-Ethylhexyl 4-(dimethylamino)benzoate; 2-Ethylhexyl N ,N -dimethyl-p -aminobenzoate; 2-Ethylhexyl p -(dimethylamino)benzoate; 4-(Dimethylamino)benzoic acid 2-ethylhexyl ester; EHDAB; Octyl dimethyl PABA; Octyl Dimethyl PABA; T/N: Unichem EHD; T/N: Escalol 507; TN: Padimate O; Ethylhexyl Dimethyl PABA; Benzoic Acid, 4( Dimethylamino )-, 2-Ethylhexyl Ester; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 21245-02-3 [RN]; 244-289-3 [EINECS]; 2-Ethylhexyl 4-(dimethylamino)benzoatato; 2-Ethylhexyl 4-(dimethylamino)benzoate [ACD/IUPAC Name]; 2-Ethylhexyl 4-dimethylaminobenzoate; 2-Ethylhexyl p-Dimethylaminobenzoate; 2-Ethylhexyl-4-(dimethylamino)benzoat [German] [ACD/IUPAC Name]; 2-Ethylhexyl-4-dimethylaminobenzoate; 2-ETHYLHEXYL-P-DIMETHYL-AMINOBENZOATE; ETHYLHEXYL DIMETHYL PABA ; 4-(Diméthylamino)benzoate de 2-éthylhexyle [French] [ACD/IUPAC Name]; 4-(Dimethylamino)benzoic Acid 2-Ethylhexyl Ester; Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester [ACD/Index Name]; Escalol 507 [Trade name]; MFCD00017526 [MDL number]; Octyl p-Dimethylaminobenzoate; Padimate O [BAN] [USAN] [Wiki]; Quantacure EHA; Sundown [Trade name]; Escalol 507; Escalol 507; Escalol 507; UNII:Z11006CMUZ; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Z11006CMUZ; [21245-02-3]; ‘21245-02-3; 212545-02-3 [RN]; 2-Ethylhexyl 4-(N ,N -dimethylamino)benzoate; 2-Ethylhexyl 4-dimethylaminobenzoate|padimate-o graessorb-o; 2-Ethylhexyl N ,N -dimethyl-p -aminobenzoate; 2-Ethylhexyl p -(dimethylamino)benzoate; 2-Ethylhexyl p-(dimethylamino)benzoate; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; 2-Ethylhexyl4-(dimethylamino)benzoate; 2-Ethylhexyl-4-(Dimethylamino)benzoate; 2-Ethylhexyl-4-(Dimethylamino)benzoate (en); 2-ETHYLHEXYL-4′-DIMETHYLAMINO- BENZOATE; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 2-ethylhexyl4-dimethylaminobenzoate; 2-Ethylhexyl-4′-dimethylamino-benzoate; 4-(dimethylamino)benzoic acid [(2S)-2-ethylhexyl] ester; 4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester; Escalol 507; Escalol 507; Escalol 507; Arlatone UVB; benzoic acid, 4-amino-, dimethyl-, 2-ethylhexyl ester; benzoic acid, octyl dimethyl-p-amino-; Benzoic acid, p-(dimethylamino)-, 2-ethylhexyl ester; BENZOIC ACID, PARA-(DIMETHYLAMINO)-, 2-ETHYLHEXYL ESTER; Caraloe Snow & Sun Lip Balm (Salt/Mix); EHDAB; Eusolex 6007; OCTYL DIMETHYL PABA CRUDE; Octyl dimethyl p-aminobenzoate; Octyl-Dimethyl-Paba; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Padimate O 100 Âµg/mL in Methanol; Padimate-O; p-Dimethylaminobenzoic acid 2-ethylhexyl ester; Photoplex; Photoplex (Salt/Mix); PreSun 15; PreSun 23 (Salt/Mix); PreSun 46; PreSun 46 (Salt/Mix); Radiacare Lip Balm; Radiacare Lip Balm (Salt/Mix); Etilheksil Dimetil PABA; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 21245-02-3; 2-Ethylhexyl 4-(dimethylamino)benzoate; Escalol 507; Escalol 507; Escalol 507; Padimate O; 2-ETHYLHEXYL 4-DIMETHYLAMINOBENZOATE; Escalol 507; Padimate-O; Octyl dimethyl PABA; Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester; Arlatone UVB; 2-Ethylhexyl p-dimethylaminobenzoate; 2-Ethylhexyl-4-dimethylaminobenzoate; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Escalol 507; Escalol 507; Escalol 507; Eusolex 6007; 2-Ethylhexyl-p-dimethyl-aminobenzoate; Radiacare Lip Balm; 4-(Dimethylamino)benzoic acid 2-ethylhexyl ester; 2-Ethylhexyl p-(dimethylamino)benzoate; Octyl dimethyl p-aminobenzoate; Caraloe Snow & Sun Lip Balm; HSDB 7169; EINECS 244-289-3; NCGC00090764-02; DSSTox_CID_9320; DSSTox_RID_78762; DSSTox_GSID_29320; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; 4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester; Benzoic acid, p-(dimethylamino)-, 2-ethylhexyl ester; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; CAS-21245-02-3; Octyl-Dimethyl-Paba; MFCD00017526; Padimate O (USP); FR-2108; Arlatone UVB (TN); Photoplex (Salt/Mix); PubChem20907; ACMC-1CD6X; Padimate o [USAN:USP]; PreSun 23 (Salt/Mix); Padimate O [USAN:BAN]; SCHEMBL15432; KSC490C3D; MLS001055379; ETHYLHEXYL DIMETHYL PABA; Padimate O, analytical standard; Radiacare Lip Balm (Salt/Mix); CHEMBL1323699; DTXSID7029320; CTK3J0131; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; KS-00000ZQC; CHEBI:135932; HMS3039F10; Tox21_111013; Escalol 507; Escalol 507; Tox21_202421; Tox21_303574; ANW-24381; SBB008471; 2-ethylhexyl4-(dimethylamino)benzoate; AKOS015890282; Tox21_111013_1; 2-Ethylhexyl-4’-dimethylamino-benzoate; AM84740; DB11570; LS-2257; MCULE-7746500520; NCGC00090764-01; NCGC00090764-03; NCGC00090764-04; NCGC00257250-01; NCGC00259970-01; AC-13165; ACM212545023; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; AK-49567; CC-10519; L263; SC-17626; SMR000677935; Caraloe Snow & Sun Lip Balm (Salt/Mix); AX8017127; DB-021046; D1871; FT-0616757; NS00005726; NS00099022; ST50826077; 2-Ethylhexyl 4-(dimethylamino)benzoate, 98%; p-Dimethylaminobenzoic acid 2-ethylhexyl ester; D05335; C-17459; SR-01000864568; Q6628390; SR-01000864568-2; 2-Ethylhexyl 4-(dimethylamino)benzoate (Octyl Dimethyl PABA); Padimate O, United States Pharmacopeia (USP) Reference Standard; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Padimate O, Pharmaceutical Secondary Standard; Certified Reference Material; 2-Ethylhexyl 4-(dimethylamino)benzoate;2-Ethylhexyl 4-(dimethylamino)benzoate (Octyl Dimethyl PABA);octyl-dimethyl-p-aminobenzoic acid;2-ethylhexyl 4-(dimethylamino)benzoate;2-ethyl-hexyl-4-dimethyl-aminobenzoate;ETHYLHEXYL DIMETHYL PABA; arlatone UVB; Escalol 507; Escalol 507; benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester; benzoic acid, p-(dimethylamino)-, 2-ethylhexyl ester; escalol 507; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; 2-ethyl hexyl 4-(dimethyl amino) benzoate; 2-ethylhexyl 4-(dimethylamino)benzoate; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 2-ethylhexyl p-(dimethylamino)benzoate; 2-ethylhexyl p-dimethylaminobenzoate; eusolex 6007; octyl dimethyl p-aminobenzoate; octyl dimethyl paba; padimate O; 2-Ethylhexyl 4-(N ,N -dimethylamino)benzoate; 2-Ethylhexyl 4-(dimethylamino)benzoate; 2-Ethylhexyl N ,N -dimethyl-p -aminobenzoate; 2-Ethylhexyl p -(dimethylamino)benzoate; 4-(Dimethylamino)benzoic acid 2-ethylhexyl ester; EHDAB; Octyl dimethyl PABA; Octyl Dimethyl PABA; T/N: Unichem EHD; T/N: Escalol 507; TN: Padimate O; Ethylhexyl Dimethyl PABA; Benzoic Acid, 4( Dimethylamino )-, 2-Ethylhexyl Ester; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 21245-02-3 [RN]; 244-289-3 [EINECS]; 2-Ethylhexyl 4-(dimethylamino)benzoatato; 2-Ethylhexyl 4-(dimethylamino)benzoate [ACD/IUPAC Name]; Escalol 507; Escalol 507; 2-Ethylhexyl 4-dimethylaminobenzoate; 2-Ethylhexyl p-Dimethylaminobenzoate; 2-Ethylhexyl-4-(dimethylamino)benzoat [German] [ACD/IUPAC Name]; 2-Ethylhexyl-4-dimethylaminobenzoate; 2-ETHYLHEXYL-P-DIMETHYL-AMINOBENZOATE; ETHYLHEXYL DIMETHYL PABA ; 4-(Diméthylamino)benzoate de 2-éthylhexyle [French] [ACD/IUPAC Name]; 4-(Dimethylamino)benzoic Acid 2-Ethylhexyl Ester; Benzoic acid, 4-(dimethylamino)-, 2-ethylhexyl ester [ACD/Index Name]; Escalol 507 [Trade name]; MFCD00017526 [MDL number]; Octyl p-Dimethylaminobenzoate; Padimate O [BAN] [USAN] [Wiki]; Quantacure EHA; Sundown [Trade name]; UNII:Z11006CMUZ; Etilheksil Dimetil PABA; etilheksil dimetil paba; Escalol 507; Escalol 507; Escalol 507; ETLHEKSL DMETL PABA; Z11006CMUZ; [21245-02-3]; ‘21245-02-3; 212545-02-3 [RN]; 2-Ethylhexyl 4-(N ,N -dimethylamino)benzoate; 2-Ethylhexyl 4-dimethylaminobenzoate|padimate-o graessorb-o; 2-Ethylhexyl N ,N -dimethyl-p -aminobenzoate; 2-Ethylhexyl p -(dimethylamino)benzoate; 2-Ethylhexyl p-(dimethylamino)benzoate; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; 2-Ethylhexyl4-(dimethylamino)benzoate; 2-Ethylhexyl-4-(Dimethylamino)benzoate; 2-Ethylhexyl-4-(Dimethylamino)benzoate (en); 2-ETHYLHEXYL-4′-DIMETHYLAMINO- BENZOATE; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; 2-ethylhexyl4-dimethylaminobenzoate; 2-Ethylhexyl-4’-dimethylamino-benzoate; 4-(dimethylamino)benzoic acid [(2S)-2-ethylhexyl] ester; 4-(Dimethylamino)benzoic acid, 2-ethylhexyl ester; ETHYLHEXYL DIMETHYL PABA ; ETHYLHEXYL DIMETHYL PABA ; Arlatone UVB; benzoic acid, 4-amino-, dimethyl-, 2-ethylhexyl ester; benzoic acid, octyl dimethyl-p-amino-; Benzoic acid, p-(dimethylamino)-, 2-ethylhexyl ester; BENZOIC ACID, PARA-(DIMETHYLAMINO)-, 2-ETHYLHEXYL ESTER; Caraloe Snow & Sun Lip Balm (Salt/Mix); EHDAB; Eusolex 6007; OCTYL DIMETHYL PABA CRUDE; Octyl dimethyl p-aminobenzoate; Octyl-Dimethyl-Paba; Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; Padimate O 100 Âµg/mL in Methanol; Padimate-O; p-Dimethylaminobenzoic acid 2-ethylhexyl ester; Photoplex; Photoplex (Salt/Mix); PreSun 15; PreSun 23 (Salt/Mix); PreSun 46; PreSun 46 (Salt/Mix); Radiacare Lip Balm; Radiacare Lip Balm (Salt/Mix); Etilheksil Dimetil PABA; etilheksil dimetil paba; ETLHEKSL DMETL PABA; ETHYLHEXYL DIMETHYL PABA; Escalol 507

ETHYLHEXYL DIMETHYL PABA

Ethylhexyl Dimethyl PABA(Escalol 507). Escalol 507 UV filter by Ashland Specialty Chemical acts as a UV filter. It is a powerful oil-soluble UV-B absorber and offers protection against UV-B and UV-A radiation. It provides cost-effective performance and excellent safety profile. Escalol 507 UV filter finds application in formulating sun-care (after-sun, self-tanning and sunscreen application), body- & facial-care formulas and color cosmetics.

Abstract

Ethylhexyl Dimethyl PABA(Escalol 507)-aminobenzoic acid (PABA) is an oily yellow liquid derivative of water-soluble PABA commonly used in sunscreen. Ethylhexyl Dimethyl PABA(Escalol 507) is widely used as an ingredient in many cosmetics at an average concentration of 1.25% (0.5-2.0%) in Korea. Previous studies, including those involving animals, have demonstrated that Ethylhexyl Dimethyl PABA(Escalol 507) is toxic to the following four organs: testis, epididymis, spleen, and liver. In addition, experiments using human keratinocytes found that Ethylhexyl Dimethyl PABA(Escalol 507) inhibits cell growth and DNA synthesis at low concentrations, and halted the cell cycle of MM96L cells (human melanoma cell line) at the G1 phase. Despite limited clinical data in humans, many studies have confirmed increased mutagenicity of Ethylhexyl Dimethyl PABA(Escalol 507) following exposure to sunlight, which suggests that this molecule is likely to contribute to onset of sun-induced cancer despite protecting the skin through absorption of UVB. For risk assessment, the no observed adverse effect level (NOAEL) chosen was 100 mg/kg bw/day in a 4 weeks oral toxicity study. Systemic exposure dosage (SED) was 0.588 mg/kg bw/day for maximum use of Ethylhexyl Dimethyl PABA(Escalol 507) in cosmetics. Based on the risk assessment and exposure scenarios conducted in this study, the margin of safety (MOS) was calculated to be 180.18 for a sunscreen containing 8% Ethylhexyl Dimethyl PABA(Escalol 507), which is the maximum level allowed by the relevant domestic authorities.

Ethylhexyl Dimethyl PABA(Escalol 507)

Ethylhexyl Dimethyl PABA(Escalol 507) is classified as :

Uv absorber

Uv filter

CAS Number 21245-02-3

EINECS/ELINCS No: 244-289-3

Restriction (applies to EU only): VII/21

COSING REF No: 33875

INN Name: padimate-O

Chem/IUPAC Name: 2-Ethylhexyl 4-(dimethylamino)benzoate

Ethylhexyl Dimethyl PABA(Escalol 507)

Icky

ALSO-CALLED-LIKE-THIS: Padimate O, Octyl Dimethyl PABA, Eusolex 6007

WHAT-IT-DOES: sunscreen

Official CosIng Information

Details

Ethylhexyl Dimethyl PABA(Escalol 507) is a chemical sunscreen agent that protects in the UVB range (290-320 nm) with a peak absorbance at 312nm. Other than that, we struggle to write anything positive about this guy, as it is photo unstable (looses 10% efficacy in 20 mins and 50% in 85 mins), not an unfrequent allergen in sunscreens and shows some endocrine effect in animal studies.

All this does not mean that it is not considered safe as used, it is (and is approved up to 8% in the EU and US and up to 3% in Japan), but we do think that there are plenty of other and better UV filters out there.

Ethylhexyl Dimethyl PABA(Escalol 507)

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Overview(active tab)

Safety

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What Is It?

Ethylhexyl Dimethyl PABA(Escalol 507) is a yellowish, oily liquid. In cosmetics and personal care products, Ethylhexyl Dimethyl PABA(Escalol 507) is used in the formulation of sunscreen products, shampoos, conditioners, hair sprays, makeup, and bath and skin products.

When it is used in sunscreen drug products, Ethylhexyl Dimethyl PABA(Escalol 507) is called Padimate O.

Why is it used in cosmetics and personal care products?

Padimate O, when applied to the skin, absorbs UV rays. In addition to causing sunburn, UV radiation is a significant cause of premature aging of the skin and contributes to the development of melanoma and other forms of skin cancer.

Ethylhexyl Dimethyl PABA(Escalol 507) can also be used to protect cosmetics and personal care products from deterioration by absorbing, UV rays

Scientific Facts:

Ethylhexyl Dimethyl PABA(Escalol 507), or Octyl Dimethyl para-Aminobenzoic Acid (PABA), absorbs ultraviolet radiation and converts it into less damaging infrared radiation (heat).

Abstract

Ethylhexyl Dimethyl PABA(Escalol 507)-aminobenzoic acid (PABA) is an oily yellow liquid derivative of water-soluble PABA commonly used in sunscreen. Ethylhexyl Dimethyl PABA(Escalol 507) is widely used as an ingredient in many cosmetics at an average concentration of 1.25% (0.5–2.0%) in Korea. Previous studies, including those involving animals, have demonstrated that Ethylhexyl Dimethyl PABA(Escalol 507) is toxic to the following four organs: testis, epididymis, spleen, and liver. In addition, experiments using human keratinocytes found that Ethylhexyl Dimethyl PABA(Escalol 507) inhibits cell growth and DNA synthesis at low concentrations, and halted the cell cycle of MM96L cells (human melanoma cell line) at the G1 phase. Despite limited clinical data in humans, many studies have confirmed increased mutagenicity of Ethylhexyl Dimethyl PABA(Escalol 507) following exposure to sunlight, which suggests that this molecule is likely to contribute to onset of sun-induced cancer despite protecting the skin through absorption of UVB. For risk assessment, the no observed adverse effect level (NOAEL) chosen was 100 mg/kg bw/day in a 4 weeks oral toxicity study. Systemic exposure dosage (SED) was 0.588 mg/kg bw/day for maximum use of Ethylhexyl Dimethyl PABA(Escalol 507) in cosmetics. Based on the risk assessment and exposure scenarios conducted in this study, the margin of safety (MOS) was calculated to be 180.18 for a sunscreen containing 8% Ethylhexyl Dimethyl PABA(Escalol 507), which is the maximum level allowed by the relevant domestic authorities.

Keywords: Ethylhexyl Dimethyl PABA(Escalol 507), Cosmetics, Sunscreen, Risk assessment, Toxicity

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INTRODUCTION

Ethylhexyl Dimethyl PABA(Escalol 507) (CAS No. 21245-02-3) is an organic derivative of water-soluble PABA (4-aminobenzoic acid) included in sunscreen and other cosmetics. It is a yellow water-insoluble oily liquid with an ester bond formed by condensation of 2-ethylhexanol and dimethylaminobenzoic acid (Fig. 1). Ethylhexyl Dimethyl PABA(Escalol 507) is also known as padimate O, OD-PABA, or octyl dimethyl p-aminobenzoate (Table 1). The Ministry of Food and Drug Safety (MFDS) and US Food and Drug Administration (FDA) mandate that its concentration in any cosmetic product shall not exceed 8% (1). Previous animal studies showed that high concentrations of Ethylhexyl Dimethyl PABA(Escalol 507) may be toxic to the epididymis and caution should be exercised when administering this substance to infants younger than six months of age due lack of understanding of its metabolism and absorption (2). Previous risk assessment data for Ethylhexyl Dimethyl PABA(Escalol 507) includes potential toxicity data and national and international regulations only. The present study summarizes a risk assessment that included determination of the margin of safety (MOS) at concentrations in cosmetics allowed by domestic authorities, a summary of existing experimental toxicity data, and exposure data associated with the amount of use in domestic cosmetic products.

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Fig. 1

Chemical structure of Ethylhexyl Dimethyl PABA(Escalol 507).

Table 1

Ethylhexyl Dimethyl PABA(Escalol 507) nomenclature and classification

CAS No. 21245-02-3

EINECS No. 244-289-3

INCI name Ethylhexyl Dimethyl PABA(Escalol 507)

IUPAC name 2-Ethylhexyl 4-(dimethylamino)benzoate

Synonyms Padimate O

Octyl dimethyl p-aminobenzoate, Octyl dimethyl PABA

2-Ethylhexyl p-(dimethylamino)benzoate

OD-PABA

Adopted from Hazardous Substances Data Bank (HSDB) & ChemIDplus (2).

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PHYSICAL AND CHEMICAL PROPERTIES

The range of purities of Ethylhexyl Dimethyl PABA(Escalol 507) used as a raw material for cosmetics is approximately 98–99.5%. It is an oily yellow liquid state with oil characteristics. It has a molecular weight of 277.4053. It is soluble in alcohol, and strong acid and base, but is insoluble in water and acetic acid (Table 2).

Table 2

Chemico-physical properties of Ethylhexyl Dimethyl PABA(Escalol 507)

Physical property Yellow liquid with oil characteristics

Molecular weight 277.4053

pKa 6.027

Boiling point 387.8°C at 760 mmHg

Melting point 242.5–243.5°C

Ignition point 124.1°C

Steam pressure 7.7 × 107 mmHg at 25°C

Specific gravity 0.99

Solubility Dissolved in alcohol, HCl, KOH

Not dissolved in acetic acid

Dissolved in water at 25°C if 5.3 × 103 mg/L

Density 1.0 ± 0.1 g/cm3

Adopted from HSDB (2).

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COSMETIC USE

Ethylhexyl Dimethyl PABA(Escalol 507) is used in sunscreen and in a variety of beauty products. According to the Environmental Working Group (EWG) database, it is used in many products including lipstick, conditioner, shampoo, anti-aging agents, hair spray, and sunscreen. Use of Ethylhexyl Dimethyl PABA(Escalol 507) in non-cosmetic products has not been reported in Korea. According to a survey conducted by the MFDS the average concentration of Ethylhexyl Dimethyl PABA(Escalol 507) in cosmetic products is 1.25% (ranging from 0.5–2.0%).

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HAZARD IDENTIFICATION

Single and repeated dose toxicity studies of Ethylhexyl Dimethyl PABA(Escalol 507) have identified various toxicities including skin irritation, reproductive toxicity, genotoxicity, and phototoxicity. Repeated dosing of experimental animals resulted in organ toxicity and organ pigmentation. The major proposed mechanism of Ethylhexyl Dimethyl PABA(Escalol 507) toxicity is DNA damage by light-modified Ethylhexyl Dimethyl PABA(Escalol 507).

General toxicity

In an acute toxicity study of Ethylhexyl Dimethyl PABA(Escalol 507), the LD50 in rats was 14,900 mg/kg (3) and no irritation was observed in a human patch test using white Vaseline® mixed with 8% Ethylhexyl Dimethyl PABA(Escalol 507).

According to a report by the Scientific Committee on Cosmetology (SCC) (1999) (4), a 4-week oral administration study was conducted in rats in accordance with GLP principles. Ethylhexyl Dimethyl PABA(Escalol 507) was administered orally (by gavage) at doses of 0, 100, 300, and 1,000 mg/kg/day (Groups 1, 2, 3, and 4, respectively) to 10 male and female rats per group. An additional 5 male and 5 female rats were added to Groups 1 and 4 to evaluate the convalescence stage. No clinical symptoms were observed except salivation in Group 4 and decreased weight in Group 4 three to four weeks after administration, which did not normalize following the convalescence period. Gross inspections during autopsies of the animals found that the capsule of the spleen was severely degraded in one female in Group 4. A male in Group 4 (4/10) exhibited a softened testis and 8 males exhibited reduced testis size. No prostate, epididymis, or seminal vesicle abnormalities were observed. Three out of the five males in the Group 4 convalescence group exhibited reduced testis size. A female rat in Group 4 showed increased spleen weight, and the females in Groups 3 and 4 exhibited increased liver weight. Furthermore, the males in Group 4 exhibited liver weight gain and pituitary gland weight loss. Among the animals in the convalescence group, the males in Group 4 exhibited kidney weight gain, but showed no changes in testis or pituitary gland weights. Histopathological examinations showed moderate or moderately severe testicular atrophy in all males in Group 4 and epididymal edema in seven out of the ten males in Group 4. All males in Group 4 had spleen pigmentation, but spleen pigmentation was more conspicuous in the females in Group 3 and was extensive in the females in Group 4. The NOAEL was determined at 100 mg/kg/day based on pigmentation of the spleen (5). The SCC determined that this NOAEL may have been too conservative, so a NOAEL value of 300 mg/kg/day was assigned to Ethylhexyl Dimethyl PABA(Escalol 507) (4).

No toxicity was observed in 20 rabbits administered 140 or 280 mg/kg/day of Ethylhexyl Dimethyl PABA(Escalol 507) for 13 weeks (4).

Reproductive and developmental toxicity

When 2 mL/kg daily Ethylhexyl Dimethyl PABA(Escalol 507) was applied to the skin of rats at 6 to 16 days of pregnancy, wavy ribs were observed on both sides of 7/56 fetuses and on one side of 2/56 fetuses. However, these observations were not attributed to Ethylhexyl Dimethyl PABA(Escalol 507) toxicity, as the rat species used in this study commonly exhibit wavy ribs (4).

According to a report by Erol et al. (6), dermal exposure to OD-PABA did not affect pubertal development or thyroid function in female or male rats. As such, OD-PABA was not classified as an endocrine disrupting chemical.

Mutagenicity/Genotoxicity

In vivo micronucleus testing was conducted on mice to evaluate mutagenesis. Ethylhexyl Dimethyl PABA(Escalol 507) (5,000 mg/kg) was intraperitoneally injected into three groups of mice (n = 10 mice per group; 30, 48, or 72 hr), resulting in no mutagenesis (3).

A chromosomal aberration test was performed in human lymphocytes. This assay is based on metabolic activation in response to the S9 mix. Ethylhexyl Dimethyl PABA(Escalol 507) was dissolved in ethanol at concentrations of 315 to 5,010 μg/mL. No chromosomal aberrations were observed (4).

Carcinogenicity

Ethylhexyl Dimethyl PABA(Escalol 507) is not considered carcinogenic per International Agency for Research on Cancer (IARC), Association Advancing Occupational and Environmental Health (ACGIH), US National Toxicology Program (NTP), and Occupational Safety and Health Administration (OSHA) (7).

Ocular irritation

Two percent Ethylhexyl Dimethyl PABA(Escalol 507) mixed with mineral oil was applied to the eyes of rabbits. No irritation was reported when both eyes are washed and left unattended (3).

A slight irritation was observed in rabbit mucous membranes during a Draize test with 2% and 5% Ethylhexyl Dimethyl PABA(Escalol 507) in mineral oil (4).

Skin irritation

Five percent Ethylhexyl Dimethyl PABA(Escalol 507) mixed with mineral oil applied to rabbit skin did not cause irritation (3,8). In addition, a patch containing Ethylhexyl Dimethyl PABA(Escalol 507) dissolved in 4% white Vaseline® affixed to adult volunteers did not cause skin sensitization (3).

No irritation was observed following application of 5% Ethylhexyl Dimethyl PABA(Escalol 507) to normal and damaged rabbit skin for 24 hr (4).

A human patch test study showed no incidence of irritation following application of yellow soft paraffin with 5% Ethylhexyl Dimethyl PABA(Escalol 507) for 48 hr (4).

When 1 mg/mL of estradiol was prescribed during the autumn and winter seasons to postmenopausal women (4 persons), women receiving hormone replacement therapy, women with sensitivity to Ethylhexyl Dimethyl PABA(Escalol 507), women with epilepsy, or women prescribed medications to control liver metabolism (aged between 54 and 63, body weight between 67 and 93 kg) along with Ethylhexyl Dimethyl PABA(Escalol 507) applied to their arm over a 10 cm2 area, daily for nine days, no skin irritation was observed (9).

Skin sensitization

Five percent Ethylhexyl Dimethyl PABA(Escalol 507) in mineral oil did not cause skin sensitization in guinea pigs. In addition, 50 μL of 0.1% Ethylhexyl Dimethyl PABA(Escalol 507) in saline was injected into ten guinea pigs, followed by nine additional 0.1 mL injections administered across three weeks. The guinea pigs did not exhibit sensitization when challenged with a 0.05 mL dose after a 12-week resting phase (4).

No skin sensitization was observed in humans following application of 1.5% or 4% Ethylhexyl Dimethyl PABA(Escalol 507) mixed with white Vaseline® (3). Furthermore, 15 volunteers were instructed to apply soft paraffin containing 4% Ethylhexyl Dimethyl PABA(Escalol 507) for three weeks, followed by a challenge application after a two week rest phase, after which no skin sensitization was observed. Consistent with this result, 150 individuals subjected to a patch test with 7% Ethylhexyl Dimethyl PABA(Escalol 507) with 3% oxybenzone did not exhibit skin sensitization (4). Another study showed that application of soft paraffin containing 7% Ethylhexyl Dimethyl PABA(Escalol 507) to 156 individuals did not cause sensitization (4). Finally, a slight stinging reaction was reported during the induction period when a mixture of 3% benzophenone and 8% Ethylhexyl Dimethyl PABA(Escalol 507) was applied to 90 individuals, but no skin sensitization was observed (4).

Phototoxicity/Photosensitization

Ten guinea pigs had their ear hair removed and a mixture of 3% oxybenzone and 7% Ethylhexyl Dimethyl PABA(Escalol 507) was applied to one ear several times, and 8-methoxypsoralen was applied to the ears of two guinea pigs as a positive control. The guinea pigs were then exposed to UV radiation for two hours. No phototoxicity was observed. Furthermore, no phototoxicity was observed when Ethylhexyl Dimethyl PABA(Escalol 507) was applied to the posterior of guinea pigs for 2 hr followed by irradiation of 3 J/cm2 at 320–400 nm (4).

No phototoxicity was observed in 26 individuals who were tested with 3% oxybenzone and 7% Ethylhexyl Dimethyl PABA(Escalol 507) (4). Furthermore, no phototoxicity was observed when 5% Ethylhexyl Dimethyl PABA(Escalol 507) in ethanol was applied and the site was irradiated with 30 J (4).

Patch testing with a mixture of 2% oxybenzone and 7% Ethylhexyl Dimethyl PABA(Escalol 507) for 24 hr was conducted on ten white-skin individuals. Following removal of the patch, the site was irradiated with UVA for 12 min followed by 1 MED (minimal erythema dose) of UVB. No phototoxicity was observed in this study (4). Furthermore, human subjects treated every 26 hr with an emulsion of stearic acid (3%), water (91%), and 4% Ethylhexyl Dimethyl PABA(Escalol 507) showed no phototoxicity.

Ethylhexyl Dimethyl PABA(Escalol 507) is harmless unless it is exposed to light. However, once activated by light, it directly damages DNA. Ethylhexyl Dimethyl PABA(Escalol 507) in commercially available sunscreen products can be activated by UVA, and to a greater extent by UVB, when exposed to sunlight (10).

Toxicokinetics

To determine whether a new metered-dose topical aerosol (MDTA) medication containing Ethylhexyl Dimethyl PABA(Escalol 507) as a skin penetration enhancer could enhance transdermal delivery of estradiol, estradiol MDTA containing Ethylhexyl Dimethyl PABA(Escalol 507) was applied to the abdomens of postmenopausal women for nine days and the levels of estradiol and estrone in the blood were measured daily via radioimmunoassay. Following MDTA treatment, 1 mg of estradiol sprayed onto three adjacent areas of skin (10 cm2) on the abdomens of each subject did not induce skin irritation. Blood estradiol concentrations were measured in four women (aged between 54 and 63 years, body weight between 67 and 93 kg). The average blood estradiol concentration was 53 pg/mL across the 9-day study period, which was significantly greater than the reference value of 13 pg/mL. (p < 0.001). This test confirmed that the MDTA containing Ethylhexyl Dimethyl PABA(Escalol 507) enhanced transdermal delivery of estradiol (9).

14C-labelled Ethylhexyl Dimethyl PABA(Escalol 507) in ethanol was applied to 100 cm2 of the forearms of each of four male and female subjects. The forearms were then covered with gauze for 24 hr after the ethanol completely evaporated. Blood was collected after 0, 2, 4, 8, 24, and 72 hr and urine was collected for 24 hr. No radioactivity was found in the blood samples while 2.45% and 1.18% radioactivity were found in the urine samples of the male and female subjects, respectively (average % of total radioactivity). The average radioactivity recovered after washing the skin at the application site was 95.7%. Assuming that 0.5 mg/cm2 was applied at a concentration of 8% to 1.8 m2, the total amount absorbed was 13 mg, or 0.2 mg/kg (4).

An oil-in-water emulsion lotion was used for an in vitro percutaneous penetration test, and guinea pig and human skin were used as the membranes. HEPES-buffered Hank’s balanced salt solution containing gentamycin sulfate and bovine serum albumin was used as the aqueous solution in the receiving chamber. The total absorption rate of Ethylhexyl Dimethyl PABA(Escalol 507) transferred to the receiving chamber and the skin was 12.7 ± 2.5%. Evaluation of Ethylhexyl Dimethyl PABA(Escalol 507) metabolism was also included in this test. Guinea pig skin hydrolyzed approximately 13–35% of Ethylhexyl Dimethyl PABA(Escalol 507) transferred to the aqueous solution through esterase activity, while human skin hydrolyzed 37% of Ethylhexyl Dimethyl PABA(Escalol 507) (11).

The value used for skin absorption in humans for the risk assessment was 2.45% based on the limited skin absorption data.

Miscellaneous materials (including clinical data)

Cell tests confirmed that Ethylhexyl Dimethyl PABA(Escalol 507) inhibited cell growth and DNA synthesis, and delayed cycle progression at 25–100 mg/mL. The CI80-13S cell line, a model of mitochondrial dysfunction, showed greater cell growth inhibition in response to ethylhexyl p-methoxycinnamate (EHMC) and PABA than the other cell lines. The pretreatment of MM96L with ethidium bromide (EtBr), which serve as mitochondrial inhibitors, followed by sunscreen treatment, resulted in apoptosis with increased uptake of ethidium bromide (12).

When keratinocytes exposed to 5 MED of sunlight were treated with sunscreen containing Ethylhexyl Dimethyl PABA(Escalol 507) (SPF 15), the number of DNA strand breaks observed here was at least 75 times higher than that in cells treated with sunscreen that did not contain Ethylhexyl Dimethyl PABA(Escalol 507) (13).

MCF-7, a human breast cancer cell line, was used to measure the estrogenic activity of Ethylhexyl Dimethyl PABA(Escalol 507). Cell proliferation rates were evaluated by attaching the estrogen receptor of Ethylhexyl Dimethyl PABA(Escalol 507), and 17β-estradiol was used as a positive control. The EC50 values for cell proliferation were 1.2 pM and 2.63 pM for 17β-estradiol and Ethylhexyl Dimethyl PABA(Escalol 507), respectively (14).

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DOSE-RESPONSE ASSESSMENT

After toxicological data were reviewed to determine the optimal toxicity reference value, the NOAEL of Ethylhexyl Dimethyl PABA(Escalol 507) was selected from a 4-week repeated dose toxicity study in rats. Ethylhexyl Dimethyl PABA(Escalol 507) dissolved in corn oil was administered to rats at concentrations of 0, 100, 300, and 1,000 mg/kg/day for four weeks by gavage, followed by four weeks of convalescence to assess the durability or reversibility of toxic effects. The results following the first four weeks showed toxicities such as increased weight and histological changes in the testes, epididymis, spleen, and liver. The assessment of reversible toxicity following four weeks of convalescence confirmed the absence of toxicity except for semen reduction in the epididymis, which was only observed in the treatment group given 1,000 mg/kg/day of Ethylhexyl Dimethyl PABA(Escalol 507). Pigmentation of the spleen was observed among males subjected to high concentrations of Ethylhexyl Dimethyl PABA(Escalol 507). This observation was more conspicuous among females treated with 300 and 1,000 mg/kg/day of Ethylhexyl Dimethyl PABA(Escalol 507). Based on the pigmentation of the spleen, NOAEL was determined to be 100 mg/kg/day (5) (Table 3).

The NOAEL was based on animal testing data and Ethylhexyl Dimethyl PABA(Escalol 507) was not considered to be of concern if the MOS was 100 or above. Based on the MOS determined using the use limit of Ethylhexyl Dimethyl PABA(Escalol 507) among domestic cosmetic products, the health risk of Ethylhexyl Dimethyl PABA(Escalol 507) for use of sunscreen was 180.18, which is significantly higher than 100, which confirmed the safety of Ethylhexyl Dimethyl PABA(Escalol 507).

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CONCLUSION

Ethylhexyl Dimethyl PABA(Escalol 507) is an organic derivative of water-soluble PABA (4-aminobenzoic acid) used as an ingredient in sunscreen and other cosmetics. Ethylhexyl Dimethyl PABA(Escalol 507) induced pigmentation of the spleen in a four-week oral administration toxicity test in rats, and the NOAEL derived from this study was 100 mg/kg/day. No significant reproductive toxicity, genotoxicity, carcinogenicity, skin sensitization, skin irritation, or phototoxicity was observed in response to Ethylhexyl Dimethyl PABA(Escalol 507) administration. The optimal NOAEL for the risk assessment was determined to be 100 mg/kg/day based on a four-week repeated toxicity study in rats. The SED of Ethylhexyl Dimethyl PABA(Escalol 507) was 0.588. The risk characterization demonstrated that Ethylhexyl Dimethyl PABA(Escalol 507) is safe to use in cosmetics in accordance with current MFDS regulations because the MOS exceeded 100 even at the maximum permitted concentration in cosmetics (8%). However, the toxicological data used in the risk assessment are limited, and if new toxicological data are reported, further assessments should be performed as appropriate.

Abstract

Ethylhexyl Dimethyl PABA(Escalol 507)-aminobenzoic acid (PABA) is an oily yellow liquid derivative of water-soluble PABA commonly used in sunscreen. Ethylhexyl Dimethyl PABA(Escalol 507) is widely used as an ingredient in many cosmetics at an average concentration of 1.25% (0.5–2.0%) in Korea. Previous studies, including those involving animals, have demonstrated that Ethylhexyl Dimethyl PABA(Escalol 507) is toxic to the following four organs: testis, epididymis, spleen, and liver. In addition, experiments using human keratinocytes found that Ethylhexyl Dimethyl PABA(Escalol 507) inhibits cell growth and DNA synthesis at low concentrations, and halted the cell cycle of MM96L cells (human melanoma cell line) at the G1 phase. Despite limited clinical data in humans, many studies have confirmed increased mutagenicity of Ethylhexyl Dimethyl PABA(Escalol 507) following exposure to sunlight, which suggests that this molecule is likely to contribute to onset of sun-induced cancer despite protecting the skin through absorption of UVB. For risk assessment, the no observed adverse effect level (NOAEL) chosen was 100 mg/kg bw/day in a 4 weeks oral toxicity study. Systemic exposure dosage (SED) was 0.588 mg/kg bw/day for maximum use of Ethylhexyl Dimethyl PABA(Escalol 507) in cosmetics. Based on the risk assessment and exposure scenarios conducted in this study, the margin of safety (MOS) was calculated to be 180.18 for a sunscreen containing 8% Ethylhexyl Dimethyl PABA(Escalol 507), which is the maximum level allowed by the relevant domestic authorities.

ETLHEKSL DMETL PABA

Etilheksil Dimetil PABA (Escalol 507). Ashland Specialty Chemical’dan Escalol 507 UV filtresi, UV filtresi görevi görür. Yada çözünen güçlü bir UV-B emicidir ve UV-B ve UV-A radyasyonuna kar koruma salar. Uygun maliyetli performans ve mükemmel güvenlik profili salar. Escalol 507 UV filtresi, güne bakm (güne sonras, kendi kendine bronzlama ve güne kremi uygulamas), vücut ve yüz bakm formülleri ve renkli kozmetiklerin formüle edilmesinde uygulama bulur.

Öz

Etilheksil Dimetil PABA (Escalol 507) -aminobenzoik asit (PABA), güne koruyucusunda yaygn olarak kullanlan, suda çözünür PABA’nn yal sar bir sv türevidir. Etilheksil Dimetil PABA (Escalol 507), Kore’de ortalama% 1,25 (% 0,5-2,0) konsantrasyonda birçok kozmetikte içerik olarak yaygn ekilde kullanlmaktadr. Hayvanlarla ilgili olanlar da dahil olmak üzere önceki çalmalar, Etilheksil Dimetil PABA’nn (Escalol 507) aadaki dört organ için toksik olduunu göstermitir: testis, epididim, dalak ve karacier. Ek olarak, insan keratinositlerini kullanan deneyler, Etilheksil Dimetil PABA’nn (Escalol 507) düük konsantrasyonlarda hücre büyümesini ve DNA sentezini engellediini ve G1 faznda MM96L hücrelerinin (insan melanom hücre hatt) hücre döngüsünü durdurduunu buldu. nsanlarda snrl klinik verilere ramen, birçok çalma, güne na maruz kalmann ardndan Etilheksil Dimetil PABA’nn (Escalol 507) artm mutajenisitesini dorulamtr; bu, bu molekülün, cildi UVB’nin emilimi yoluyla korumasna ramen, günein neden olduu kanserin balamasna katkda bulunabileceini göstermektedir. . Risk deerlendirmesi için, 4 haftalk bir oral toksisite çalmasnda seçilen advers etki gözlenmeyen seviye (NOAEL) 100 mg / kg canl arlk / gün’dür. Kozmetiklerde Etilheksil Dimetil PABA’nn (Escalol 507) maksimum kullanm için sistemik maruziyet dozu (SED) 0.588 mg / kg canl arlk / gün’dür. Bu çalmada gerçekletirilen risk deerlendirmesi ve maruziyet senaryolarna göre, ilgili yerel makamlarca izin verilen maksimum düzey olan% 8 Etilheksil Dimetil PABA (Escalol 507) içeren bir güne koruyucu için güvenlik marj (MOS) 180,18 olarak hesaplanmtr. .

Etilheksil Dimetil PABA (Escalol 507)

Etilheksil Dimetil PABA (Escalol 507) u ekilde snflandrlr:

Uv emici

UV filtresi

CAS Numaras 21245-02-3

EINECS / ELINCS No: 244-289-3

Kstlama (yalnzca AB için geçerlidir): VII / 21

COSING REF No: 33875

INN Ad: padimate-O

Chem / IUPAC Ad: 2-Etilheksil 4- (dimetilamino) benzoat

Etilheksil Dimetil PABA (Escalol 507)

Icky

BU GB AYRICA-BU: Padimate O, Octyl Dimethyl PABA, Eusolex 6007

NE YAPAR: güne kremi

Resmi CosIng Bilgileri

Detaylar

Etilheksil Dimetil PABA (Escalol 507), 312 nm’de bir pik absorbans ile UVB aralnda (290-320 nm) koruyan kimyasal bir güne koruyucu ajandr. Bunun dnda, fotoraf dengesiz olduu için (20 dakikada% 10, 85 dakikada% 50), güne kremlerinde sk olmayan bir alerjen olmad ve hayvan çalmalarnda bir miktar endokrin etkisi gösterdii için bu adam hakknda olumlu bir ey yazmakta zorlanyoruz.

Bütün bunlar, kullanld haliyle güvenli olmad anlamna gelmez, öyle (ve AB ve ABD’de% 8’e kadar ve Japonya’da% 3’e kadar onaylanmtr), ancak daha pek çok ve daha iyisi olduunu düünüyoruz. UV filtreleri var.

Etilheksil Dimetil PABA (Escalol 507)

Mesajlar

Genel Bak (etkin sekme)

Emniyet

Kaynaklar

Bu ne?

Etilheksil Dimetil PABA (Escalol 507) sarms, yal bir svdr. Kozmetik ve kiisel bakm ürünlerinde Ethylhexyl Dimethyl PABA (Escalol 507) güne koruyucu ürünler, ampuanlar, saç kremleri, saç spreyleri, makyaj, banyo ve cilt ürünlerinin formülasyonunda kullanlr.

Güneten koruyucu ilaç ürünlerinde kullanldnda Ethylhexyl Dimethyl PABA (Escalol 507) Padimate O olarak adlandrlr.

Neden kozmetik ve kiisel bakm ürünlerinde kullanlr?

Padimate O cilde uygulandnda UV nlarn emer. Güne yanna neden olmann yan sra, UV radyasyonu cildin erken yalanmasnn önemli bir nedenidir ve melanom ve dier cilt kanseri türlerinin gelimesine katkda bulunur.

Etilheksil Dimetil PABA (Escalol 507) ayrca kozmetik ve kiisel bakm ürünlerini UV nlarn emerek bozulmadan korumak için de kullanlabilir.

Bilimsel gerçekler:

Etilheksil Dimetil PABA (Escalol 507) veya Oktil Dimetil para-Aminobenzoik Asit (PABA), ultraviyole radyasyonu emer ve onu daha az zarar veren kzlötesi radyasyona (s) dönütürür.

Öz

Anahtar Kelimeler: Etilheksil Dimetil PABA (Escalol 507), Kozmetik, Güne Kremi, Risk deerlendirmesi, Toksisite

uraya gidin:

Etilheksil Dimetil PABA (Escalol 507) (CAS No. 21245-02-3), güne kremi ve dier kozmetiklerde bulunan suda çözünür PABA’nn (4-aminobenzoik asit) organik bir türevidir. 2-etilheksanol ve dimetilaminobenzoik asidin younlamasyla oluan ester bana sahip sar suda çözünmeyen yal bir svdr (ekil 1). Etilheksil Dimetil PABA (Escalol 507) ayn zamanda padimat O, OD-PABA veya oktil dimetil p-aminobenzoat olarak da bilinir (Tablo 1). Gda ve laç Güvenlii Bakanl (MFDS) ve ABD Gda ve laç Dairesi (FDA) herhangi bir kozmetik üründeki konsantrasyonunun% 8’i (1) geçmemesini zorunlu klar. Önceki hayvan çalmalar, yüksek Etilheksil Dimetil PABA (Escalol 507) konsantrasyonlarnn epididim için toksik olabileceini ve bu maddeyi alt aylktan küçük bebeklere uygularken metabolizmasn ve emilimini anlama eksiklii nedeniyle dikkatli olunmas gerektiini göstermitir (2) . Ethylhexyl Dimethyl PABA (Escalol 507) için önceki risk deerlendirme verileri, yalnzca potansiyel toksisite verilerini ve ulusal ve uluslararas düzenlemeleri içerir. Bu çalma, yerel otoriteler tarafndan izin verilen kozmetik konsantrasyonlarnda güvenlik marjnn (MOS) belirlenmesini, mevcut deneysel toksisite verilerinin bir özetini ve ev içi kozmetik ürünlerdeki kullanm miktar ile ilikili maruz kalma verilerini içeren bir risk deerlendirmesini özetlemektedir.

Bir resim, illüstrasyon vb. çeren harici bir dosya.

Nesne ad tr-35-131f1.jpg’dir

ekil 1

Ethylhexyl Dimethyl PABA’nn (Escalol 507) kimyasal yaps.

tablo 1

Etilheksil Dimetil PABA (Escalol 507) isimlendirme ve snflandrma

CAS No. 21245-02-3

EINECS No. 244-289-3

INCI ad Etilheksil Dimetil PABA (Escalol 507)

IUPAC ad 2-Etilheksil 4- (dimetilamino) benzoat

Eanlamllar Padimate O

Oktil dimetil p-aminobenzoat, Oktil dimetil PABA

2-Etilheksil p- (dimetilamino) benzoat

OD-PABA

Tehlikeli Maddeler Veri Bankas (HSDB) ve ChemIDplus (2) ‘den kabul edilmitir.

uraya gidin:

FZKSEL VE KMYASAL ÖZELLKLER

Kozmetikler için hammadde olarak kullanlan Etilheksil Dimetil PABA’nn (Escalol 507) saflk aral yaklak% 98-99,5’tir. Ya özellii olan yal sar bir sv haldir. 277.4053 moleküler arla sahiptir. Alkolde ve kuvvetli asit ve bazda çözünür, ancak suda ve asetik asitte çözünmez (Tablo 2).

Tablo 2

Etilheksil Dimetil PABA’nn (Escalol 507) kimyasal-fiziksel özellikleri

Fiziksel özellik Ya özellikli sar sv

Molekül arl 277.4053

pKa 6.027

760 mmHg’de kaynama noktas 387,8 ° C

Erime noktas 242,5–243,5 ° C

Tutuma noktas 124.1 ° C

25 ° C’de buhar basnc 7,7 × 107 mmHg

Özgül arlk 0.99

Çözünürlük Alkol, HCl, KOH içinde çözünmü

Asetik asitte çözünmez

5,3 × 103 mg / L ise 25 ° C’de suda çözülür

Younluk 1.0 ± 0.1 g / cm3

HSDB’den (2) kabul edilmitir.

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KOZMETK KULLANIM

Ethylhexyl Dimethyl PABA (Escalol 507) güne koruyucu ve çeitli güzellik ürünlerinde kullanlr. Çevresel Çalma Grubu (EWG) veritabanna göre ruj, saç kremi, ampuan, yalanmay geciktirici maddeler, saç spreyi ve güne kremi gibi birçok üründe kullanlmaktadr. Kore’de kozmetik olmayan ürünlerde Ethylhexyl Dimethyl PABA (Escalol 507) kullanm bildirilmemitir. MFDS tarafndan yaplan bir aratrmaya göre kozmetik ürünlerdeki ortalama Etilheksil Dimetil PABA (Escalol 507) konsantrasyonu% 1,25’tir (% 0,5-2,0 arasnda).

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TEHLKE TANIMI

Ethylhexyl Dimethyl PABA’nn (Escalol 507) tek ve tekrarlanan doz toksisite çalmalar, cilt tahrii, üreme toksisitesi, genotoksisite ve fototoksisite dahil çeitli toksisiteler tanmlamtr. Deney hayvanlarnn tekrarlanan dozlar, organ toksisitesi ve organ pigmentasyonu ile sonuçland. Etilheksil Dimetil PABA (Escalol 507) toksisitesinin önerilen balca mekanizmas, kla modifiye edilmi Etilheksil Dimetil PABA (Escalol 507) tarafndan DNA hasardr.

Genel toksisite

Etilheksil Dimetil PABA’nn (Escalol 507) bir akut toksisite çalmasnda, sçanlarda LD50 14.900 mg / kg’dr (3) ve% 8 Etilheksil Dimetil PABA (Escalol 507) ile kartrlm beyaz Vaseline® kullanlarak yaplan bir insan yama testinde tahri gözlenmemitir. ).

Bilimsel Kozmetoloji Komitesi (SCC) (1999) (4) tarafndan hazrlanan bir rapora göre, GLP ilkelerine uygun olarak sçanlarda 4 haftalk bir oral uygulama çalmas yaplmtr. Etilheksil Dimetil PABA (Escalol 507), 0, 100, 300 ve 1,000 mg / kg / gün dozlarnda (srasyla Grup 1, 2, 3 ve 4) 10 erkek ve dii sçana oral yoldan (gavajla) uyguland. grubu. yileme aamasn deerlendirmek için Grup 1 ve 4’e ek bir 5 erkek ve 5 dii sçan eklendi. Grup 4’te tükürük salgs dnda hiçbir klinik semptom gözlenmedi ve Grup 4’te uygulamadan üç ila dört hafta sonra kilo azald, bu iyileme dönemini takiben normale dönmedi. Hayvanlarn otopsileri srasnda yaplan kapsaml incelemeler, dalak kapsülünün Grup 4’teki bir kadnda ciddi ekilde bozulmu olduunu buldu. Grup 4’teki (4/10) bir erkek, yumuatlm bir testis sergiledi ve 8 erkek, testis boyutu küçültüldü. Prostat, epididim veya seminal vezikül anormallikleri gözlenmedi. 4. Grup nekahat grubundaki be erkekten üçünde testis boyutu küçüldü. Grup 4’teki bir dii sçan, artan dalak arl gösterdi ve Grup 3 ve 4’teki diiler, artm karacier arl sergiledi. Ayrca, Grup 4’teki erkekler karacier kilo alm ve hipofiz bezi kilo kayb gösterdi. yileme grubundaki hayvanlar arasnda, Grup 4’teki erkekler böbrek arl art sergilediler, ancak testis veya hipofiz bezi arlklarnda hiçbir deiiklik göstermedi. Histopatolojik incelemeler Grup 4’teki tüm erkeklerde orta veya orta derecede iddetli testis atrofisi ve Grup 4’teki on erkekten yedisinde epididimal ödem gösterdi. Grup 4’teki tüm erkeklerde dalak pigmentasyonu vard, ancak Grup 3’teki kadnlarda dalak pigmentasyonu daha belirgindi. Grup 4’teki kadnlarda yaygnd. NOAEL dalak pigmentasyonuna göre 100 mg / kg / gün olarak belirlendi (5). SCC, bu NOAEL’in çok muhafazakar olabileceini belirledi, bu nedenle 300 mg / kg / gün NOAEL deeri, Etilheksil Dimetil PABA’ya (Escalol 507) (4) atand.

13 hafta boyunca günde 140 veya 280 mg / kg Etilheksil Dimetil PABA (Escalol 507) uygulanan 20 tavanda toksisite gözlenmemitir (4).

Üreme ve geliimsel toksisite

Gebelikten 6-16. Günlerde sçanlarn derisine günde 2 mL / kg Etilheksil Dimetil PABA (Escalol 507) uygulandnda, 7/56 fetüsün her iki tarafnda ve 2/56 fetüsün bir tarafnda dalgal kaburgalar görüldü. Bununla birlikte, bu çalmada kullanlan sçan türleri yaygn olarak dalgal kaburgalar sergilediinden, bu gözlemler Etilheksil Dimetil PABA (Escalol 507) toksisitesine atfedilmemitir (4).

Erol ve ark. (6), OD-PABA’ya dermal maruziyet dii veya erkek sçanlarda pubertal geliimi veya tiroid fonksiyonunu etkilememitir. Bu nedenle OD-PABA, bir endokrin bozucu kimyasal olarak snflandrlmamtr.

Mutajenite / Genotoksisite

n vivo mikronükleus testi, mutajenezin deerlendirilmesi için fareler üzerinde gerçekletirildi. Etilheksil Dimetil PABA (Escalol 507) (5,000 mg / kg) intraperitoneal olarak üç fare grubuna (grup bana n = 10 fare; 30, 48 veya 72 saat) enjekte edilerek mutajenez olmamtr (3).

nsan lenfositlerinde bir kromozomal aberasyon testi yapld. Bu test, S9 karmna yant olarak metabolik aktivasyona dayanmaktadr. Etilheksil Dimetil PABA (Escalol 507), 315 ila 5,010 ug / mL’lik konsantrasyonlarda etanol içerisinde çözündürüldü. Kromozom anormallikleri gözlenmedi (4).

Kanserojenlik

Etilheksil Dimetil PABA (Escalol 507), Uluslararas Kanser Aratrma Ajans (IARC), Mesleki ve Çevre Sal Gelitirme Dernei (ACGIH), ABD Ulusal Toksikoloji Program (NTP) ve Mesleki Güvenlik ve Salk daresi (OSHA) bana kanserojen olarak kabul edilmez ( 7).

Göz tahrii

Tavanlarn gözlerine mineral ya ile kartrlm yüzde iki Etilheksil Dimetil PABA (Escalol 507) uyguland. Her iki göz ykandnda ve gözetimsiz brakldnda tahri bildirilmedi (3).

Mineral ya (4) içinde% 2 ve% 5 Etilheksil Dimetil PABA (Escalol 507) ile bir Draize testi srasnda tavan mukoz membranlarnda hafif bir tahri gözlenmitir.

Cilt tahrii

Tavan derisine uygulanan mineral ya ile kartrlan yüzde be Etilheksil Dimetil PABA (Escalol 507) tahrie neden olmad (3,8). Ek olarak, yetikin gönüllülere yaptrlm% 4 beyaz Vazelin® içinde çözülmü Etilheksil Dimetil PABA (Escalol 507) içeren bir yama cilt hassasiyetine neden olmad (3).

24 saat boyunca normal ve hasarl tavan derisine% 5 Etilheksil Dimetil PABA’nn (Escalol 507) uygulanmasnn ardndan hiçbir tahri gözlenmedi (4).

Bir insan yama testi çalmas, 48 saat boyunca% 5 Etilheksil Dimetil PABA (Escalol 507) içeren sar yumuak parafin uygulamasnn ardndan hiçbir tahri vakas göstermedi (4).

Sonbahar ve k mevsimlerinde menopoz sonras kadnlara (4 kii), hormon replasman tedavisi alan kadnlara, Etilheksil Dimetil PABA’ya (Escalol 507) duyarl kadnlara, epilepsili kadnlara veya kadnlara ilaç reçete edildiinde 1 mg / mL estradiol reçete edildiinde kontrol karacier metabolizmas (54-63 ya, vücut arl 67-93 kg arasnda) ile birlikte kollarna 10 cm2 alan üzerinde Etilheksil Dimetil PABA (Escalol 507), dokuz gün boyunca günlük olarak uygulandnda, cilt tahrii gözlenmedi (9) .

Cilt hassasiyeti

Mineral yadaki yüzde be Etilheksil Dimetil PABA (Escalol 507) kobaylarda cilt hassasiyetine neden olmad. Ek olarak, salin içinde 50 uL% 0.1 Etilheksil Dimetil PABA (Escalol 507) on kobay içine enjekte edildi, ardndan üç hafta boyunca dokuz ek 0.1 mL enjeksiyon uyguland. Gine domuzlar, 12 haftalk bir dinlenme fazndan sonra 0.05 mL doz ile tehdit edildiinde duyarllk göstermedi (4).

Beyaz Vaseline® (3) ile kartrlm% 1.5 veya% 4 Etilheksil Dimetil PABA (Escalol 507) uygulamasnn ardndan insanlarda cilt hassaslamas gözlenmedi. Ayrca, 15 gönüllüye üç hafta boyunca% 4 Etilheksil Dimetil PABA (Escalol 507) içeren yumuak parafin uygulamas, ardndan iki haftalk dinlenme aamasndan sonra bir meydan okuma uygulamas talimat verildi, ardndan cilt hassaslamas gözlenmedi. Bu sonuçla tutarl olarak,% 3 oksibenzonlu% 7 Etilheksil Dimetil PABA (Escalol 507) ile bir yama testine tabi tutulan 150 kii, cilt hassaslamas göstermedi (4). Baka bir çalma,% 7 Etilheksil Dimetil PABA (Escalol 507) içeren yumuak parafinin 156 kiiye uygulanmasnn duyarlla neden olmadn göstermitir (4). Son olarak, indüksiyon döneminde 90 kiiye% 3 benzofenon ve% 8 Etilheksil Dimetil PABA (Escalol 507) karm uygulandnda hafif bir batma reaksiyonu bildirildi, ancak ciltte hassasiyet gözlenmedi (4).

Fototoksisite / Fotosensitizasyon

On gine domuzunun kulak tüyleri çkarld ve% 3 oksibenzon ve% 7 Etilheksil Dimetil PABA (Escalol 507) karm bir kulaa birkaç kez uyguland ve pozitif kontrol olarak iki kobayn kulaklarna 8-metoksipsoralen uyguland. . Gine domuzlar daha sonra iki saat süreyle UV radyasyonuna maruz brakld. Fototoksisite gözlenmedi. Ayrca, 2 saat boyunca kobaylarn arkasna Etilheksil Dimetil PABA (Escalol 507) uygulandnda, 320-400 nm’de 3 J / cm2 nlandnda fototoksisite gözlenmedi (4).

% 3 oksibenzon ve% 7 Etilheksil Dimetil PABA (Escalol 507) (4) ile test edilen 26 kiide hiçbir fototoksisite gözlenmemitir. Ayrca, etanol içinde% 5 Etilheksil Dimetil PABA (Escalol 507) uygulandnda ve bölge 30 J (4) ile nlandnda fototoksisite gözlenmedi.

On beyaz tenli birey üzerinde 24 saat boyunca% 2 oksibenzon ve% 7 Etilheksil Dimetil PABA (Escalol 507) karm ile yama testi yapld. Yamann çkarlmasnn ardndan, alan, 12 dakika boyunca UVA ile ve ardndan 1 MED (minimum eritem dozu) UVB ile nland. Bu çalmada herhangi bir fototoksisite gözlenmemitir (4). Ayrca, her 26 saatte bir stearik asit (% 3), su (% 91) ve% 4 Etilheksil Dimetil PABA (Escalol 507) emülsiyonu ile tedavi edilen insan süjeler hiçbir fototoksisite göstermedi.

Etilheksil Dimetil PABA (Escalol 507) a maruz kalmad sürece zararszdr. Bununla birlikte, kla aktive edildiinde, dorudan DNA’ya zarar verir. Ticari olarak temin edilebilen güne koruyucu ürünlerdeki Etilheksil Dimetil PABA (Escalol 507), güne na maruz kaldnda UVA ile ve daha büyük ölçüde UVB ile aktive edilebilir (10).

Toksikokinetik

Cilt penetrasyon artrc olarak Etilheksil Dimetil PABA (Escalol 507) içeren yeni bir ölçülü doz topikal aerosol (MDTA) ilacnn estradiolün transdermal datmn artrp artrmayacan belirlemek için, Etilheksil Dimetil PABA (Escalol 507) içeren estradiol MDTA’nn karnlarna uygulanp uygulanmadn belirlemek için. postmenopozal kadnlar dokuz gün boyunca ve kandaki estradiol ve estron seviyeleri radyoimmunoassay ile günlük olarak ölçüldü. MDTA tedavisini takiben, her bir denein abdomeni üzerindeki üç bitiik cilt bölgesine (10 cm2) püskürtülen 1 mg estradiol, cilt tahriine neden olmad. Kan estradiol konsantrasyonlar dört kadnda (54-63 ya aras, vücut arl 67-93 kg aras) ölçüldü. Ortalama kan estradiol konsantrasyonu, 9 günlük çalma süresi boyunca 53 pg / mL idi ve bu, 13 pg / mL referans deerinden önemli ölçüde daha yüksekti. (p <0,001). Bu test Etilheksil Dimetil PABA (Escalol 507) içeren MDTA’nn estradiolün transdermal datmn arttrdn dorulad (9).

Etanol içinde 14C etiketli Etilheksil Dimetil PABA (Escalol 507), dört erkek ve dii denein her birinin ön kollarnn 100 cm2’sine uyguland. Ön kollar daha sonra etanol tamamen buharlatktan sonra 24 saat boyunca gazl bezle kapatld. 0, 2, 4, 8, 24 ve 72 saat sonra kan topland ve 24 saat idrar topland. Kan örneklerinde radyoaktivite bulunmazken, erkek ve dii deneklerin idrar örneklerinde srasyla% 2,45 ve% 1,18 radyoaktivite (ortalama% toplam radyoaktivite) bulundu. Uygulama yerinde cildin ykanmasndan sonra geri kazanlan ortalama radyoaktivite% 95,7 idi. 0.5 mg / cm2’nin% 8 ila 1.8 m2’lik bir konsantrasyonda uyguland varsayldnda, emilen toplam miktar 13 mg veya 0.2 mg / kg idi (4).

Bir in vitro perkütan penetrasyon testi için suda ya emülsiyon losyonu kullanld ve membranlar olarak kobay ve insan derisi kullanld. HEPES tamponlu Hank’in gentamisin sülfat ve sr serum albümini içeren dengeli tuz çözeltisi, alc bölmede sulu çözelti olarak kullanld. Etilheksil Dimetil PABA’nn (Escalol 507) toplam absorpsiyon oran, alc bölmeye aktarlan ve cilt% 12.7 ± 2.5 idi. Etilheksil Dimetil PABA (Escalol 507) metabolizmasnn deerlendirilmesi de bu teste dahil edildi. Kobay derisi, Etilheksil Dimetil PABA’nn (Escalol 507) yaklak% 13–35’ini hidrolize ederken, esteraz aktivitesi yoluyla sulu çözeltiye aktarlrken, insan cildi Etilheksil Dimetil PABA’nn (Escalol 507)% 37’sini hidrolize etti (11).

nsanlarda cilt absorpsiyonu için risk deerlendirmesi için kullanlan deer, snrl cilt absorpsiyon verilerine göre% 2.45’tir.

Çeitli malzemeler (klinik veriler dahil)

Hücre testleri, Etilheksil Dimetil PABA’nn (Escalol 507) hücre büyümesini ve DNA sentezini inhibe ettiini ve 25-100 mg / mL’de döngü ilerlemesini geciktirdiini dorulad. Bir mitokondriyal disfonksiyon modeli olan CI80-13S hücre çizgisi, etilheksil p-metoksisinamata (EHMC) ve PABA’ya yant olarak dier hücre hatlarndan daha fazla hücre büyümesi inhibisyonu gösterdi. MM96L’nin mitokondriyal inhibitör olarak görev yapan etidyum bromür (EtBr) ile ön tedavisi ve ardndan güne koruyucu tedavisi, etidyum bromür almnn artmasyla apoptozla sonuçland (12).

5 MED güne na maruz kalan keratinositler, Etilheksil Dimetil PABA (Escalol 507) (SPF 15) içeren güne kremi ile muamele edildiinde, burada gözlemlenen DNA iplii krlmalarnn says, güne kremi ile muamele edilmi, içermeyen hücrelerdekinden en az 75 kat daha yüksekti. Etilheksil Dimetil PABA (Escalol 507) (13).

Etilheksil Dimetil PABA’nn (Escalol 507) östrojenik aktivitesini ölçmek için bir insan göüs kanseri hücre hatt olan MCF-7 kullanld. Hücre proliferasyon oranlar, Etilheksil Dimetil PABA’nn (Escalol 507) östrojen reseptörü balanarak deerlendirildi ve bir pozitif kontrol olarak 17p-estradiol kullanld. Hücre çoalmas için EC50 deerleri 17p-estradiol ve Etilheksil Dimetil PABA (Escalol 507) için srasyla 1.2 pM ve 2.63 pM idi (14).

uraya gidin:

DOZ TEPKS DEERLENDRMES

Optimal toksisite referans deerini belirlemek için toksikolojik veriler gözden geçirildikten sonra, Etilheksil Dimetil PABA’nn (Escalol 507) NOAEL’i sçanlarda 4 haftalk tekrarlanan doz toksisite çalmasndan seçilmitir. Msr yanda çözündürülen etilheksil dimetil PABA (Escalol 507), sçanlara dört hafta boyunca 0, 100, 300 ve 1.000 mg / kg / gün konsantrasyonlarda gavaj yoluyla uyguland, ardndan dört haftalk iyileme süreci izledi. toksik etkiler. lk dört haftay takip eden sonuçlar, testis, epididim, dalak ve karacierde kilo art ve histolojik deiiklikler gibi toksisiteler gösterdi. Dört haftalk iyileme dönemini takiben geri dönüümlü toksisite deerlendirmesi, yalnzca 1.000 mg / kg / gün Etilheksil Dimetil PABA (Escalol 507) verilen tedavi grubunda gözlenen epididimde semen azalmas dnda toksisitenin olmadn dorulad. Yüksek konsantrasyonlarda Etilheksil Dimetil PABA’ya (Escalol 507) maruz kalan erkeklerde dalak pigmentasyonu gözlendi. Bu gözlem, 300 ve 1.000 mg / kg / gün Etilheksil Dimetil PABA (Escalol 507) ile tedavi edilen kadnlar arasnda daha belirgindi. Dalan pigmentasyonuna göre NOAEL’in 100 mg / kg / gün olduu belirlendi (5) (Tablo 3).

NOAEL, hayvan test verilerine dayanyordu ve MOS 100 veya üzeri ise Etilheksil Dimetil PABA (Escalol 507) endie kayna olarak görülmedi. Yerli kozmetik ürünler arasnda Etilheksil Dimetil PABA (Escalol 507) kullanm limiti kullanlarak belirlenen MOS’a göre, Etilheksil Dimetil PABA’nn (Escalol 507) güne kremi kullanmndaki salk riski, 100’den önemli ölçüde daha yüksek olan 180.18 idi. Etilheksil Dimetil PABA’nn (Escalol 507) güvenlii.

uraya gidin:

SONUÇ

Etilheksil Dimetil PABA (Escalol 507), güne kremi ve dier kozmetiklerde bileen olarak kullanlan suda çözünür PABA’nn (4-aminobenzoik asit) organik bir türevidir. Etilheksil Dimetil PABA (Escalol 507), sçanlarda dört haftalk bir oral uygulama toksisite testinde dalan pigmentasyonunu indükledi ve bu çalmadan türetilen NOAEL, 100 mg / kg / gündü. Etilheksil Dimetil PABA (Escalol 507) uygulamasna yant olarak hiçbir önemli üreme toksisitesi, genotoksisite, kanserojenlik, cilt hassasiyeti, cilt tahrii veya fototoksisite gözlenmemitir. Risk deerlendirmesi için optimal NOAEL, sçanlarda dört haftalk tekrarlanan toksisite çalmasna göre 100 mg / kg / gün olarak belirlenmitir. Etilheksil Dimetil PABA’nn (Escalol 507) SED’si 0.588 idi. Risk karakterizasyonu, Etilheksil Dimetil PABA’nn (Escalol 507), kozmetikte izin verilen maksimum konsantrasyonda (% 8) bile MOS 100’ü at için mevcut MFDS düzenlemelerine uygun olarak kozmetikte kullanmnn güvenli olduunu göstermitir. Bununla birlikte, risk deerlendirmesinde kullanlan toksikolojik veriler snrldr ve yeni toksikolojik veriler rapor edilirse, uygun ekilde baka deerlendirmeler yaplmaldr.

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ESCALOL 507

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ESCALOL 507

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