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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 from handbook or collection of data

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Toxicity of test chemical
Author:
IFA GESTIS
Year:
2018
Bibliographic source:
GESTIS Substance Database

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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
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.