Registration Dossier
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EC number: 226-109-5 | CAS number: 5281-04-9
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 from handbook or collection of data
Data source
Reference
- Reference Type:
- other: Authoritative database
- Title:
- Toxicity of test chemical
- Author:
- IFA GESTIS
- Year:
- 2 018
- Bibliographic source:
- GESTIS Substance Database
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- An eye irritation study of test chemical D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) was conducted on rabbits to observe its irritation efficacy in accordance with OECD guideline 405 .
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- EC Number:
- 226-109-5
- EC Name:
- Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate
- Cas Number:
- 5281-04-9
- Molecular formula:
- C18H14N2O6S.Ca
- IUPAC Name:
- calcium 3-hydroxy-4-[(1E)-2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-2-carboxylate
- Details on test material:
- - IUPAC Name: calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Common Name: D & C Red no. 7- InChI:1S/C18H14N2O6S.Ca/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/p-2/b20-19+;- Smiles:c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]- Name of test material (as cited in study report):C. I. Pigment 57:1- Molecular formula :C18H12CaN2O6S- Molecular weight :424.445 g/mol- Substance type:organic- Physical state:solid
Constituent 1
- Specific details on test material used for the study:
- - IUPAC Name: calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate- Common Name: D & C Red no. 7- InChI:1S/C18H14N2O6S.Ca/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/p-2/b20-19+;- Smiles:c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]- Name of test material (as cited in study report):C. I. Pigment 57:1- Molecular formula :C18H12CaN2O6S- Molecular weight :424.445 g/mol- Substance type:organic- Physical state:solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No Data Available
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- No Data Available
- Duration of treatment / exposure:
- No Data Available
- Observation period (in vivo):
- No Data Available
- Duration of post- treatment incubation (in vitro):
- 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
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No eye irritation was observed in treated rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Conclusions:
- The test material D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) was considered to be not irritating to the eyes of rabbits.
- Executive summary:
An eye irritation study of test chemicalD&C Red 7/ Lithol rubine BK (CAS No:5281-04-9)was conducted on rabbits to observe its irritation efficacy in accordance with OECD guideline 405.
In this study, the test chemical was instilled into each rabbit’s eye and eye reactions were observed.
Since the test chemical did not cause irritation, thetest materialD&C Red 7/ Lithol rubine BK (CAS No:5281-04-9)was considered to be not irritating to rabbits’ eye.
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