Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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:
Opinion of the Scientific Committee on Consumer Safety on Basic Violet 2 (B115)
Author:
Scientific Committee on Consumer Safety
Year:
2011
Bibliographic source:
The Scientific Committee on Consumer Products, SCCS/1340/10,2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Buehler method
Principles of method if other than guideline:
To determine the skin sensitization potential of (4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1 ylidene)methyl]-o-toluidine monohydrochloride) by Buehler method
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
Not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride/ 3248-91-7
/ 221-831-7
Commen name-Basic Violet 2
mol.formula:C22H23N3 .HCl
smiles:C(\c1cc(c(N)cc1)C)(c1cc(c(N)cc1)C)=C1\C=C(C(=[NH+])C=C1)C.[ClH-]
InChI:1S/C22H23N3.ClH/c1-13-10-16(4-7-19(13)23)22(17-5-8-20(24)14(2)11-17)18-6-9-21(25)15(3)12-18;/h4-12,23H,24-25H2,1-3H3;1H
Physical state: Solid Green crystalline powder
molecular weight:365.906 g/mol
Specific details on test material used for the study:
4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride/ 3248-91-7
/ 221-831-7
Commen name-Basic Violet 2
mol.formula:C22H23N3 .HCl
smiles:C(\c1cc(c(N)cc1)C)(c1cc(c(N)cc1)C)=C1\C=C(C(=[NH+])C=C1)C.[ClH-]
InChI:1S/C22H23N3.ClH/c1-13-10-16(4-7-19(13)23)22(17-5-8-20(24)14(2)11-17)18-6-9-21(25)15(3)12-18;/h4-12,23H,24-25H2,1-3H3;1H
purity: 94%
molecular weight:365.906 g/mol
Physical state: Solid Green crystalline powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
75%
Day(s)/duration:
16 Days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
50%
Day(s)/duration:
1 day
Adequacy of challenge:
not specified
No. of animals per dose:
The test group consisted of 20 female Guinea pigs
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Not specified
- Exposure period: 6 hrs
- Test groups:20 animals
- Control group: 20
- Site: left flank
- Frequency of applications: Not specified
- Duration: 16 hrs
- Concentrations: 75%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6 hrs
- Test groups: 20
- Control group:20
- Site: Not specified
- Concentrations: 50%
Evaluation (hr after challenge): 24 and 48 hrs

OTHER: vehicle alone on the contralateral flank was applied
Challenge controls:
two control groups of ten female Guinea
pigs each
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
Total no. in group:
20
Clinical observations:
No clinical signs appered.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Non skin sensitizing
Conclusions:
The Basic Violet 2 was considered skin non sensitizing as no differences between values of the test group compared to values of the control group were apparent
Executive summary:

Basic Violet 2 was assessed for its skin sensitizing potential by Buehler test on Dunkin-Hartley guinea pig The test group consisted of 20 female Guinea pigs, two control groups of ten female Guinea pigs each. During the induction phase, the test group was treated with the test substance in sterile water at 75% at the left flank. The negative control groups were treated with the vehicle (sterile water) in the same manner. The gauze patches with test substance or vehicle under occlusive dressing were removed after 6 hours. Approximately 24 hours after removal of the patches, skin reactions were scored. These procedures were repeated at weekly intervals (days 8/9 and 15/16 of the study). On study day 29, sensitisation reactions were challenged in the test as well as in one negative control group by topical administration of the test substance in sterile water (50% on one side and vehicle alone on the contralateral flank) under occlusive dressing for 6 hours.

Twenty-four and 48 hours after removal of the patches the skin reactions were scored. Following the 48 hour examination at challenge, skin fold thickness of the treated sites was measured using a digital micrometer. Body weights were recorded on days 1 and 31 (termination of the study). Body weights were not affected by the test compound.

The Basic Violet 2 was considered skin non sensitizing as no differences between values of the test group compared to values of the control group were apparent.