Bis(p-aminophenyl)-4-methylenecyclohexa-2,5-dienylideneammonium acetate

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:

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

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

Test material information

Constituent 1

Reference substance name:

4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride

EC Number:

221-831-7

EC Name:

4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride

Cas Number:

3248-91-7

Molecular formula:

C22H24ClN3

IUPAC Name:

4-[(4-amino-3-methylphenyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-2-methylaniline hydrochloride

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:

- Name of test material: C.I. Basic Violet 2 / (4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride)
- IUPAC name: 4-[(4-amino-3-methylphenyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-2-methylaniline hydrochloride
- Molecular formula: C22H24ClN3
- Molecular weight: 365.906 g/mole
- Smiles :C(\c1cc(c(N)cc1)C)(c1cc(c(N)cc1)C)=C1\C=C(C(=[NH+])C=C1)C.[ClH-]
- Inchl: 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
- Substance type: Organic
- 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 chemical

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:

Basic Violet 2 was considered skin non sensitizing when tested on Dunkin-Hartley guinea pigs.

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.

Basic Violet 2 was considered skin non sensitizing  when tested on Dunkin-Hartley guinea pigs.