Sodium 2-(p-aminoanilino)-5-nitrobenzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from handbook or collection of data

Data source

Reference

Reference Type:

other: Authoritive database

Title:

Eye irritation for CAS NO: 91-29-2

Author:

IFA GESTIS

Year:

2017

Bibliographic source:

GESTIS SUBSTANCE Database (information system in hazardous substance of the Berufsgenossenscheftn).

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Ocular irritation study of 4-nitro-4’-aminodiphenylamine-2-sulfonic acid was carried out in 6 rabbits in accordance with OECD guideline No. 405

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-aminoanilino)-5-nitrobenzenesulphonic acid

EC Number:

202-057-9

EC Name:

2-(4-aminoanilino)-5-nitrobenzenesulphonic acid

Cas Number:

91-29-2

Molecular formula:

C12H11N3O5S

IUPAC Name:

2-[(4-aminophenyl)amino]-5-nitrobenzenesulfonic acid

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): 4-nitro-4’-aminodiphenylamine-2-sulfonic acid (91-29-2)
- Molecular formula: C12H11N3O5S
- Molecular weight : 309.301 g/mol
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4-nitro-4’-aminodiphenylamine-2-sulfonic acid
- Molecular formula: C12H11N3O5S
- Molecular weight: 309.301 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

100 µl

Duration of treatment / exposure:

3 days

Observation period (in vivo):

3 days

Duration of post- treatment incubation (in vitro):

No data available

Number of animals or in vitro replicates:

6

Details on study design:

TEST SITE
- Area of exposure: the conjunctival sac of eye
- % coverage: No data
- Type of wrap if used: No data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data
SCORING SYSTEM: No data

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 3 days

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Slight reddening in only one of 6 animals was observed but this was reversible after 3 days.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Slight reddening in only one of 6 animals was observed but this was reversible after 3 days.
Since the observed effects were fully reversible within 3 days ,the test chemical 4-nitro-4’-aminodiphenylamine-2-sulfonic acid (CAS No:91-29-2) was considered to be not irritating to rabbits’ eye.

Executive summary:

Eye irritation study was conducted in 6 rabbits for 4-nitro-4’-aminodiphenylamine-2-sulfonic acid (CAS No: 91-29-2) to assess its eye irritation efficacy in accordance with OECD guideline 405. About 100 μl of 4-nitro-4’-aminodiphenylamine-2-sulfonic acid was placed into the conjunctival sac of each rabbits and the results were recorded for 3 days. Slight reddening in only one of 6 animals was observed but this was reversible after 3 days.

Since the observed eye effects were fully reversible within 3 days, the test chemical 4-nitro-4’-aminodiphenylamine-2-sulfonic acid (CAS No:91-29-2) was considered to be not irritating to rabbits’ eye.