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Toxicological information

Eye irritation

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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 authoritative database.

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Name of the test chemical: disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate
Common Name: D & C Red No. 6
Molecular Formula: C18H12N2Na2O6S
Molecular Weight: 430.3468 g/mol
InChI: 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
SMILES:Cc1ccc(N=Nc2c3ccccc3cc(C(=O)O{-}.[Na]{+})c2O)c(S(=O)(=O)O{-}.[Na]{+})c1

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:
The test substance was installed into conjunctival sac of rabbits 5 times per week for 4 weeks.
Observation period (in vivo):
4 weeks
Duration of post- treatment incubation (in vitro):
no data available
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
Remarks:
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 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 installations of 0.2 ml of a 10% aqueous suspension of the test chemical into the conjunctival sac of rabbits 5 times per week for 4 weeks. The chemical produced only minimal irritative 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.