N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

data is from experimental reports following standard procedures

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the dermal irritation potential of Basic Violet 3 in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride

EC Number:

208-953-6

EC Name:

[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride

Cas Number:

548-62-9

Molecular formula:

C25H30N3.Cl

IUPAC Name:

(4-(4,4'-Bis(dimethylamino)benzhydrylidene)cyclohexa-2,5-dien-1-ylidene)dimethylammonium, chloride

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report):Gentian violet
- IUPAC name: N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Molecular formula : C25H30N3.Cl
Molecular weight : 407.986 g/mol
- Smiles notation: C(\c1ccc(N(C)C)cc1)(c1ccc(N(C)C)cc1)=C1\C=C\C(=[N+](/C)C)C=C1.[ClH-]
- InChl:1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Crystal violet
- IUPAC name: N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride
- Molecular formula: C25H30N3.Cl
Molecular weight: 407.986 g/mol
- Smiles notation: C(\c1ccc(N(C)C)cc1)(c1ccc(N(C)C)cc1)=C1\C=C\C(=[N+](/C)C)C=C1.[ClH-]
- InChl:1S/C25H30N3.ClH/c1-26(2)22-13-7-19(8-14-22)25(20-9-15-23(16-10-20)27(3)4)21-11-17-24(18-12-21)28(5)6;/h7-18H,1-6H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

other: albino rabbits

Details on test animals or test system and environmental conditions:

sex: male

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

no data available

Duration of treatment / exposure:

24 hours

Observation period:

observations were made just after patch removal and also at 48 hours

Number of animals:

6 male albino rabbits

Details on study design:

TEST SITE
- Area of exposure: trunk and lateral areas
- % coverage: one inch sqaures of test material were applied to intact skin under 1inch*1inch gauze squares (double thickness)
- Type of wrap if used: rubber sheeting was loosely wrapped around the trunk and secured with an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : observations were made just after patch removal and also at 48 hours

SCORING SYSTEM:
- Method of calculation: the observations were graded according to the system of the regulations of the Federal Hazardous Substances Act.

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

the test material failed to produce any dermal reactions in the rabbits

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Basic Violet 3 failed to produce any dermal reactions in the rabbits.
Hence, Basic Violet 3 was considered to be not irritating to rabbit skin.

Executive summary:

The dermal irritation potential of Basic Violet 3 was assessed in rabbits. 6 male albino rabbits were clipped free of hair on the trunk and lateral areas and placed in a FDA- type stocks. One inch sqaures of test material were applied to intact skin under 1inch*1inch gauze squares (double thickness). Rubber sheeting was loosely wrapped around the trunk and secured with an adhesive tape. After 24 hours, the rabbits were removed from the stocks and reactions were graded. Observations were also made at 48 hours. The observations were graded according to the system of the regulations of the Federal Hazardous Substances Act.

Basic Violet 3 (CAS No: 548-62-9) failed to produce any dermal reactions in the rabbits. Hence, Basic Violet 3 was considered to be not irritating to rabbit skin.