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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 Secondary literature

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Opinion of the Scientific Committee on Consumer Safety Basic Violet 2 COLIPA no 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:

oral toxicity study of Basic Violet 2 in the rat

Author:

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

Year:

2002

Bibliographic source:

RTC (Research Toxicology Centre, Roma), 7121/T/213/99, October 02, 2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

The Acute oral toxicity test of Basic Violet 2 (3248-91-7) was performed in Sprague Dawley Rat according to OECD guideline no. 401 (1987).

GLP compliance:

not specified

Test type:

other: No data available

Limit test:

yes

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

Details on test material:

- Name of test material (IUPAC name): 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride]
- Common name: LOWACRYL VIOLET 2
- Molecular formula: C22H24ClN3
- Molecular weight: 365.906 g/mol
- Smiles notation: 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

Specific details on test material used for the study:

- Name of test material (as cited in study report):Basic Violet 2
- Molecular formula:C22H23N3.HCl
- Molecular weight:365.91 g/mol
- Substance type:organic
- Physical state:Green powder
-Purity:83.7%
- Impurities (identity and concentrations):16.3 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% CMC aqueous solution

Details on oral exposure:

Details on exposure
VEHICLE
- Concentration in vehicle:500, 1000 and 2000 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

DOSAGE PREPARATION (if unusual): the test substance was soluble in CMC aqueous solution.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data available

Doses:

500, 1000 and 2000 mg/kg bw

No. of animals per sex per dose:

FOR LIMIT TEST:
Total: 10 animals
Females: 5 and Males: 5

FOR MAIN STUDY:
TOTAL: 30 animals
500 mg/kg bw = 5 males and 5 females
1000 mg/kg bw = 5 males and 5 females
2000 mg/kg bw = 5 males and 5 females

Control animals:

not specified

Details on study design:

No data available

Statistics:

No data available

Results and discussion

Preliminary study:

LIMIT TEST STUDY:
Mortality:3 males died within 5 days of dosing.
Clinical signs: Piloerection, breathing difficulties, staining of fur, urine and faeces were observed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: At 2000 mg/kg bw, 1 male and 1 female died within 48 hours of dosing. No mortalities were observed at 500, 1000 mg/kg dose levels.

Mortality:

At 2000 mg/kg bw, 1 male and 1 female died within 48 hours of dosing. No mortalities were observed at 500, 1000 mg/kg bw dose levels.

Clinical signs:

other: At 2000 mg/kg bw: piloerection, reduced activity, hunched posture, breathing difficulties, staining of fur, urine and faeces, swollen abdomen.

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The LD50 value was considered to be > 2000 mg/kg bw,when Sprague Dawley rats were treated with 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride (3248-91-7) orally.

Executive summary:

In acute oral toxicity study, 5 males and 5 females Sprague Dawley rats per group were treated with 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride(3248-91-7) with dose level of 500,1000 and 2000 mg/kg bw.0.5% CMC aqueous solution was used as a vehicle.3 males died within 5 days of dosing. At 2000 mg/kg bw, 1 male and 1 female died within 48 hours of dosing. No mortalities were observed at 500, 1000 mg/kg bw dose levels.Clinical signs at 2000 mg/kg bw observed were piloerection, reduced activity, hunched posture, breathing difficulties, staining of fur, urine and faeces, swollen abdomen. Therefore, Lethal dose (LD50) value was considered to be >2000 mg/kg bw when rats were treated with 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride orally.