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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
The data was from safety assesment report.

Data source

Reference
Reference Type:
secondary source
Title:
Environment and Quality of Life - Reports (Seventh Series)- Basic violet 14
Author:
European Commission (EC) - Scientific Committee on Cosmetology (SCC)
Year:
1988
Bibliographic source:
Environment and Quality of Life - Reports (Seventh Series)- Basic violet 14 European Commission (EC) - Scientific Committee on Cosmetology (SCC) 1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mention below
Principles of method if other than guideline:
To evaluate the skin irritation potential for ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride) on Rabbit
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUPAC name:((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl
Specific details on test material used for the study:
IUPAC name:((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
commen name : Basic violet 14
Molecular formula :C20H19N3.ClH
molecular weight: 337.8 g/mol
InChI:1S/C20H19N3.ClH/c1-13-12-16(6-11-19(13)23)20(14-2-7-17(21)8-3-14)15-4-9-18(22)10-5-15;/h2-12,21H,22-23H2,1H3;1H/b20-14-,21-17?
Smiles:C(\c1cc(c(N)cc1)C)(c1ccc(N)cc1)=C1/C=CC(=N)C=C1.Cl

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:
other: Propylene glycol
Controls:
not specified
Amount / concentration applied:
0.5% in Propylene glycol
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
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Basic Violet 14 did not produce edema and no microscopic changes were observed on the treated skin sites.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
Basic violet 14 when topically applied on rabbit skin produced no skin reaction.
Hence, Basic Violet 14 can be considered to be not irritating to skin.
Executive summary:

Skin irritation test was performed on rabbits to assess the irritation potential of Basic Violet 14. 0.5% Basci violet 14 in Propylene glycol was applied to the skin of rabbits and observed for signs of irritation (duration and number of animals not mentioned).

Basic Violet 14 did not produce edema and no microscopic changes were observed on the treated skin sites.

Hence, Basic Violet 14 can be considered to be not irritating to skin.