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EC number: 229-054-5 | CAS number: 6408-31-7
Eye irritation
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:
- opinion of the scientific committee on cosmetic products and non-food products intended for consumers, CAS NO: 25956-17-6 (curry red)
- Author:
- European Commission (EC)
- Year:
- 2 004
- Bibliographic source:
- opinion of the scientific committee on cosmetic products and non-food products intended for consumers, CAS NO: 25956-17-6 (curry red) SCCNFP/0791/2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- An ocular irritation study was conducted on New Zealand White rabbits to determine the eye irritation potential of chemical Acid Yellow 23 (CAS No: 1934-21-0).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- EC Number:
- 217-699-5
- EC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Cas Number:
- 1934-21-0
- Molecular formula:
- C16H12N4O9S2.3Na
- IUPAC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Test material form:
- solid
- Details on test material:
- - Name of test material (IUPAC name): trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Common name: Acid Yellow 23,Tartrazine
- Molecular formula: C16H9N4Na3O9S2
- Molecular weight:534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type: Organic
- Physical state:Soild
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (IUPAC name): trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Common name: Acid Yellow 23,Tartrazine
- Molecular formula: C16H9N4Na3O9S2
- Molecular weight:534.3681 g/mol
- Smiles notation: n1(c2ccc(cc2)S(=O)(=O)[O-])c(c(c(n1)C(=O)[O-])/N=N/c1ccc(cc1)S(=O)(=O)[O-])O.[Na+].[Na+].[Na+]
-InChl:1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3/b18-17+;;;
- Substance type: Organic
- Physical state:Soild
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data available
Test system
- Vehicle:
- other: 0.5 % (w/v) hydroxypropyl methylcellulose and 0.25 % (w/v) laureth-10 acetate)
- Controls:
- yes
- Amount / concentration applied:
- 3% (30 μl)
- Duration of treatment / exposure:
- 1 application daily for 21 days
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 12 rabbits (6/sex)
- Details on study design:
- -Area of exposure: the right eye
- Type of wrap if used:
SCORING SYSTEM: Ocular irritation was determined according to a modification of the Draize test. All animals were checked for viability twice daily.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 21 d
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No lethality or significant clinical signs, and no substance-related weight change were observed. Except slight conjunctival redness or discharge, that were seen sporadically in the eyes of the animals, all animals were free of significant signs of ocular irritation. No significant signs of eye staining or particle depositions were observed. At ophthalmoscopic examinations, no ocular abnormities were noticed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The test material Acid Yellow 23 (CAS No: 1934-21-0) was considered to be not irritating to the eye of New Zealand White rabbits.
- Executive summary:
An ocular irritation study was conducted on New Zealand White rabbits to determine the eye irritation potential of chemical Acid Yellow 23 (CAS No: 1934-21-0).
About 30 μl of test solution (3 % (w/v) Acid Yellow 23 in aqueous solution with 0.5 % (w/v) hydroxypropyl methylcellulose and 0.25 % (w/v) laureth-10 acetate) or vehicle were administered to the right eye of 6 female and 6 male rabbits, followed by closing the eye for approx. 1 sec to prevent substance loss. Ocular irritation was determined according to a modification of the Draize test. All animals were checked for viability twice daily.
Ocular irritation was scored 24 h after each treatment and prior to the next instillation. On days 1, 3, 7, 14, and 21 the eyes were also evaluated 1 h after treatment. 24 h after each treatment additionally eye stain and particle depositions were scored. Ophthalmic observations were conducted on days 3, 7 and 14 always prior to instillation. The left eyes served as untreated controls.
No lethality or significant clinical signs, and no substance-related weight change were observed. Except slight conjunctival redness or discharge, that were seen sporadically in the eyes of the animals, all animals were free of significant signs of ocular irritation. No significant signs of eye staining or particle depositions were observed. At ophthalmoscopic examinations, no ocular abnormities were noticed.
Thus on the basis of observed ocular effects, the chemical Acid Yellow 23 (CAS No: 1934-21-0) was considered as not irritating to the New Zealand White rabbits’ eyes.
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