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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from Scientific Committee on Cosmetology

Data source

Reference
Reference Type:
secondary source
Title:
Reports of the Scientific Committee on Cosmetology concerning the use of certain colouring agents in cosmetic production
Author:
Commission of the European Communities
Year:
1988
Bibliographic source:
Reports of the Scientific Committee on Cosmetology – SCC (seventh series)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A skin irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) in vivo.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 3-(p-anilinophenylazo)benzenesulphonate
EC Number:
209-608-2
EC Name:
Sodium 3-(p-anilinophenylazo)benzenesulphonate
Cas Number:
587-98-4
Molecular formula:
C18H14N3O3S.Na
IUPAC Name:
sodium 3-(p-anilinophenylazo)benzenesulphonate
Test material form:
solid
Details on test material:
- Name of test material: Ext. D&C Yellow No. 1
- IUPAC name: sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula: C18H15N3O3SNa
- Molecular weight: 375.383 g/mol
- Substance type: organic
- Physical state: solid
- Purity: No data available
- Impurities (identity and concentrations): no data available
Specific details on test material used for the study:
- Name of test material : sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula : C18H14N3O3S.Na
- Molecular weight: 375.383 g/mol
- Smiles notation : c1(Nc2ccccc2)ccc(\N=N\c2cc(ccc2)S(=O)(=O)[O-])cc1.[Na+]
- InChl : 1S/C18H15N3O3S.Na/c22-25(23,24)18-8-4-7-17(13-18)21-20-16-11-9-15(10-12-16)19-14-5-2-1-3-6-14;/h1-13,19H,(H,22,23,24);/q;+1/p-1/b21-20+;
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 g of a 50% aqueous suspension
Duration of treatment / exposure:
not specified
Observation period:
not specified
Number of animals:
not specified
Details on study design:
not specified

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not specified
Score:
0
Reversibility:
not specified
Remarks on result:
other: no ither details mentioned

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) was determined to be negative for skin irritation test on application of 0.5 g to rabbits.
Executive summary:

A skin irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36) in vivo. The concentration used was 0.5 g of a 50% aqueous suspension. The results were determined to be negative for skin irritation test on rabbits. This indicates that the test substance can be considered as a Not classified under Skin Irritation category as per CLP classification criteria.