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Toxicological information

Acute Toxicity: oral

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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

Referenceopen allclose all

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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
At 2000 mg/kg bw: piloerection, reduced activity, hunched posture, breathing difficulties, staining of fur, urine and faeces, swollen abdomen.
Body weight:
No data available
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.