Sodium 3-(p-anilinophenylazo)benzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye 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 report

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:

Eye irritation test in rabbits were carried out to measure the effects of the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid Yellow 36).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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 / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

other: water/propylene glycoL (1:1)

Controls:

not specified

Amount / concentration applied:

0.25%

Duration of treatment / exposure:

not specified

Observation period (in vivo):

not specified

Duration of post- treatment incubation (in vitro):

not specified

Number of animals or in vitro replicates:

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 other details available

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 in eye irritation test on application of 0.1 ml of a 0.25% solution in water/propylene glycol (1:1) to rabbits eye.

Executive summary:

In vivo eye irritation test in rabbits were carried out with colourant test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid yellow 36). 0.1 ml of a 0.25% solution in water/propylene glycol (1:1) was applied. It was found to be not irritating. This indicates that the test substance can be considered as a Not classified under Eye irritation category as per CLP classification criteria.