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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
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 mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitization potential of ((4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data avialable

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: Aqueous solution of gum arabic
Concentration / amount:
5% in 25 % Aqueous solution of gum arabic
Day(s)/duration:
5 days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
intradermal
Vehicle:
other: saline
Concentration / amount:
0.1ml 0.01, 0.001, and 0.001% in saline.
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
not specified
Details on study design:
RANGE FINDING TESTS: No data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period: no data
- Test groups: No data
- Control group: No data
- Site: No data
- Frequency of applications: daily for 5 days
- Duration: 5 days
- Concentrations: 5% in 25% Aqueous solution of gum arabic

B. CHALLENGE EXPOSURE
- No. of exposures: no data
- Day(s) of challenge: no data
- Exposure period: no data
- Test groups: no data
- Control group: no data
- Site: no data
- Concentrations: 0.1ml 0.01, 0.001, and 0.001% in saline
- Evaluation (hr after challenge): no data
Challenge controls:
Not specified
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
0.1ml 0.01, 0.001, and 0.001% in saline
Clinical observations:
No dermal reaction were observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
No signs of any skin allergic reaction were observed. Hence, Basic Violet 14 can be considered to be not sensitizing to guinea pig skin.
Executive summary:

Skin sensitization test was performed using basic violet 14 as test material on guinea pigs. The test material was applied topically 5% in 25%Aqueous solution of gum Arabic to the skin of guinea pigs for 5 days. After 2 weeks of rest period the challenge treatment was provided by epicuteneous injection of concentration 0.1ml 0.01, 0.001, and 0.001% in saline. The guinea pigs were observed for signs of dermal sensitization after the challenge exposure.

No signs of any skin allergic reaction were observed. Hence, Basic Violet 14 can be considered to be not sensitizing to guinea pig skin.