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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
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 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The skin 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 404.

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

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No Data Available

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
No Data Available
Duration of treatment / exposure:
No Data Available
Observation period:
No Data Available
Number of animals:
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: No Data Available
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:
Conclusions:
The test material D&C Red 7/ Lithol rubine BK (CAS No: 5281-04-9) was considered to be not irritating to the skin of rabbits.
Executive summary:

The skin 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 404.

 

In this study, the test chemical was applied dermally on to each rabbit’s skin 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’ skin.