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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer-reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
List of colorants to be classified as toxic
Author:
R Anliker, G Diirig, D Steinle and E J Moriconi
Year:
1988
Bibliographic source:
Journal of the Society of Dyers and Colourists, Volume 104 May/June 1988,223-225
Reference Type:
review article or handbook
Title:
Ecological and toxicological properties of dyestuffs
Author:
Chittaradan Desai
Year:
1992
Bibliographic source:
Ecological and toxicological properties of dyestuffs, Chittaradan Desai,Colourage,December 1992,page No. 51-54

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute Oral toxicity test was carried out to study the effects of 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) on rats.
GLP compliance:
not specified
Test type:
other: no data available
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Solid crystalline powder
Details on test material:
- Name of test material: 2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium chloride / Basic Red 12 / C.I. 48070
- IUPAC name: 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride
- Molecular formula: C25H29ClN2
- Molecular weight: 392.971 g/mole
- Smiles : c12c(C(C)(C)C(\N1C)=C/C=C/C=1C(c3ccccc3[N+]1C)(C)C)cccc2.[ClH-]
- Inchl: 1S/C25H29N2.ClH/c1-24(2)18-12-7-9-14-20(18)26(5)22(24)16-11-17-23-25(3,4)19-13-8-10-15-21(19)27(23)6;/h7-17H,1-6H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid crystalline powder (Violet)
Specific details on test material used for the study:
- Name of test material (as cited in study report):C.I. Basic Red 12
- Molecular formula :C25H29N2.Cl
- Molecular weight :392.971 g/mol
- Substance type:organic
- Physical state:No data
- Purity :>98%
- Impurities (identity and concentrations):<2% (The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.)

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No data available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
25 mg/kg bw and 31 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
25 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed at dose 25 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
31 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 50% mortality was observed at dose 31 mg/kg bw
Mortality:
50% mortality was observed at dose 25 mg/kg bw and 31 mg/kg bw
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be 25 mg/kg bw in female rats and 31 mg/kg bw in male rats ,when rats were treated with 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) orally according to OECD Guideline 401 (Acute Oral toxicity).
Executive summary:

Acute oral toxicity study was performed in rats using test material 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5).50% mortality was observed at dose 25 and 31 mg/kg bw. Hence,LD50 value was considered to be 25 mg/kg bw in female rats and 31 mg/kg bw in male rats,when rats were treated with 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride(6320-14-5) orally according to OECD Guideline 401 (Acute Oral toxicity).