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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:
publication
Title:
OPINION ON Acid Orange 7
Author:
European Commission
Year:
2011
Bibliographic source:
Scientific Committee on Consumer Safety SCCS OPINION ON Acid Orange 7 COLIPA n° C15;22 March 2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The eye irritation study was conducted to evaluate the irritating effects of administration of sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate to eye of rabbits.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
EC Number:
211-199-0
EC Name:
Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
Cas Number:
633-96-5
Molecular formula:
C16H12N2O4S.Na
IUPAC Name:
sodium 4-[(2-hydroxy-1-naphthyl)diazenyl]benzenesulfonate
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material : sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate (Acid Orange 7)
- Molecular formula :C16H12N2O4S.Na
- Molecular weight :350.3289 g/mol
- Substance type:organic
- physical state:Solid powder
-InChI:1S/C16H12N2O4S.Na/c19-15-10-5-11-3-1-2-4-14(11)16(15)18-17-12-6-8-13(9-7-12)23(20,21)22;/h1-10,19H,(H,20,21,22);/q;+1/p-1/b18-17+
-Smiles:c12c(\N=N\c3ccc(S(=O)(=O)[O-])cc3)c(ccc1cccc2)O.[Na+]
Specific details on test material used for the study:
- Name of test material : sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate (Acid Orange 7)
- Molecular formula :C16H12N2O4S.Na
- Molecular weight :350.3289 g/mol
- Substance type:organic
- physical state:Solid powder
-InChI:1S/C16H12N2O4S.Na/c19-15-10-5-11-3-1-2-4-14(11)16(15)18-17-12-6-8-13(9-7-12)23(20,21)22;/h1-10,19H,(H,20,21,22);/q;+1/p-1/b18-17+
-Smiles:c12c(\N=N\c3ccc(S(=O)(=O)[O-])cc3)c(ccc1cccc2)O.[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:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
no data
Observation period (in vivo):
No data available
Duration of post- treatment incubation (in vitro):
No data available
Number of animals or in vitro replicates:
3 males
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Reversibility:
not specified
Remarks on result:
other: Irritation effects was not observed.
Irritant / corrosive response data:
No ocular irritation reactions were observed

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
During experimental study 100 mg of test compound sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate was administered to eye of 3 male rabbits,no sign of irritation was observed during experiment thus it is concluded that sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate dose not classify as eye irritant.
Executive summary:

Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulphonate was used as a teat material to evaluate eye irritation potential .

The test material was administrated on the eye of 3 male rabbits in the concentration 100 mg . No sign of irritation was observed during experiment thus it is concluded that sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate dose not classify as eye irritant.