Registration Dossier
Registration Dossier
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EC number: 211-189-6 | CAS number: 632-99-5
Skin sensitisation
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:
- 1 988
- 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
- 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 substance name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- EC Number:
- 211-189-6
- EC Name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- Cas Number:
- 632-99-5
- Molecular formula:
- C20H19N3.ClH
- IUPAC Name:
- (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride
- 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
Constituent 1
- 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 chemical
- 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.
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