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

Skin irritation / corrosion

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:

Data is from safety assesment report

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Opinion of the Scientific Committee on Consumer Safety on Basic Violet 2 (B115)

Author:

Scientific Committee on consumer products – SCCP

Year:

2011

Bibliographic source:

Scientific committee on consumer products – SCCP, COLIPA no B115 during 12th plenary meeting of 20 September 2011

Reference 2

Reference Type:

secondary source

Title:

Opinion of the SCCNFP on B115, Basic Violet 2

Author:

Scientific Committee On Cosmetic Products And Non-Food Products (SCCNFP)

Year:

2004

Bibliographic source:

Scientific Committee On Cosmetic Products And Non-Food Products (SCCNFP) 2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

To evaluate the skin irritation potential of 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride on rabbits

GLP compliance:

no

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

Test material form:

other: Solid crystalline powder

Details on test material:

- 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: Dark green powder

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

3 female rabbits of New Zealand White strain were used.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

500 mg/1ml of water

Duration of treatment / exposure:

4 hrs

Observation period:

1, 24, 48, and 72 hrs

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: No Data available
- % coverage: No Data available
- Type of wrap if used: semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool soaked with water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Erythema could not be assessed due to intense staining of the skin

Other effects:

No edema was noted in any of the test animals. Measurement of skin-fold thickness after 72 hours revealed no differences between treated skin and untreated (naive) skin.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Basic Violet 2 was considered to be non –irritant to skin of rabbit in the concentration 0.5 g for 4 hrs

Executive summary:

Basic Violet 2 of purity 94% was used as a test substance for determining its skin irritation potential. 3 females New Zealand albino white rabbit were used as test animals.

A gauze square with 0.5 g test material mixed to a paste with sterile water was placed on the shaved skin of three female rabbits and covered with a semi-occlusive dressing for 4 hours.

After the 4-hour application time, the area was wiped with cotton wool soaked with water. The animals were checked daily for mortality and systemic symptoms. Skin reactions were evaluated 1, 24, 48, and 72 hours after removing the patches according to the Draize scoring system.

No irritation was recorded in any test animals.Erythema could not be assessed due to intense staining of the skin. No oedema was noted in any of the test animals. Measurement of skin-fold thickness after 72 hours revealed no differences between treated skin and untreated (naive) skin. Erythema assessments after a longer period (when discolouration of the skin had disappeared) have not been performed.

Basic Violet 2 was considered to be skin non –irritant to the skin of rabbits.