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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment report.

Data source

Reference
Reference Type:
secondary source
Title:
Reports of the Scientific Committee on Cosmetology
Author:
Commission of the European Communities
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series), European Communities, 1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the eye irritation potential of the test chemical in rabbit.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
-IUPAC name :Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
-Common name-1-(2-methoxy-5-methyl-4-sulfophenyl-1-azo)-6 sulfo-2-hydroxynapthalene, disodium salt ( ALLURA RED AC)
-Molecular formula:C18H16N2O8S2.2Na
-Molecular weight:496.4266 g/mol
- Substance type: Organic
- Physical state: solid
-InChI:1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H,1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
Smiles:c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N=N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O.[Na+].[Na+]

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:
0.1 ml of 1.0% aqueous solution
Duration of treatment / exposure:
No data available
Observation period (in vivo):
No data available
Number of animals or in vitro replicates:
No data available
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Not specified
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No ocular reaction were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
No ocular reaction was observed .Hence, the test chemical was considered to be not eye irritant.
Executive summary:

A study was performed to assess the ocular irritation potential of the test chemical.

0.1 ml1.0% aqueous solution of the test chemical was instilled into rabbit eye and observed for the signs of irritation .No ocular reaction was observed .Hence, the test chemical was considered to be not irritating to eyes.