2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt

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: Authoritative database

Title:

Eye irritation Test for the test chemical

Author:

IFA GESTIS

Year:

2018

Bibliographic source:

GESTIS SUBSTANCE Database, 2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The local eye irritative potential of test chemical was investigated in rabbits’ eye to assess the degree of eye irritancy caused by the chemical.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

EC Number:

227-497-9

EC Name:

Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Cas Number:

5858-81-1

Molecular formula:

C18H14N2O6S.2Na

IUPAC Name:

disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate

Test material form:

solid

Details on test material:

- Name of test material (IUPAC name): disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
- Molecular formula: C18H12N2Na2O6S
- Molecular weight: 430.3468 g/mol
- Smiles notation: c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Na+].[Na+]
- InChl: 1S/C18H14N2O6S.2Na/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;;/h2-9,21H,1H3,(H,22,23)(H,24,25,26);;/q;2*+1/p-2/b20-19+;;
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not specified

Test system

Vehicle:

other: aqueous suspension

Controls:

not specified

Amount / concentration applied:

2 instillations of 10% (0.2ml)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

The test substance was installed into conjunctival sac of rabbits 5 times per week for 4 weeks.

Number of animals or in vitro replicates:

no data available

Details on study design:

- Area of exposure: conjunctival sac of rabbits

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 weeks

Reversibility:

fully reversible within: 24 Hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Only minimal irritative effects after 2 hours.

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

The chemical produced only minimal irritating effects after 2 hours which could not confirmed the irritation potential. Hence, on the basis of findings the Test chemical can be considered as not irritating to the rabbits’ eye.

Executive summary:

The local eye irritative potential of test chemical was investigated in rabbits’ eye to assess the degree of eye irritancy caused by the chemical. Each rabbit received 2 installation of 0.2 ml of a 10% test chemical aqueous suspension into the conjunctival sac of rabbits 5 times per week for 4 weeks. The chemical produced only minimal irritating effects after 2 hours which could not confirmed the irritation potential. Hence, on the basis of findings the Test chemical can be considered as not irritating to the rabbits’ eye.