Registration Dossier
Registration Dossier
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EC number: 202-039-0 | CAS number: 91-08-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is fromauthorized database
Data source
Reference
- Reference Type:
- other: authorized database
- Title:
- Single Dose Oral Toxicity Test of Tolylene diisocyanate in Rats
- Author:
- J-CHECK
- Year:
- 2 012
- Bibliographic source:
- Ministry of Health, Labour and Welfare", "Ministry of the Environment" and "National Institute of Technology and Evaluation, J-CHECK 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The single dose toxicity test of 2, 6Toluene diisocyanate in male and female Crj: CD (SD) rats by oral (gavage) administration.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- m-tolylidene diisocyanate
- EC Number:
- 247-722-4
- EC Name:
- m-tolylidene diisocyanate
- Cas Number:
- 26471-62-5
- IUPAC Name:
- 2,4-diisocyanato-1-methylbenzene
- Reference substance name:
- Toluene diisocyanate
- IUPAC Name:
- Toluene diisocyanate
- Details on test material:
- - Name of test material (as cited in study report): Toluene diisocyanate
- Molecular formula (if other than submission substance): C9H6N2O2
- Molecular weight (if other than submission substance): 174.16 g/mole
- Substance type: Organic
- Physical state: Colorless to yellow liquid ... turns pale yellow on exposure to air
Purity >99%
Remarks The test substance Toluene diisocyanate was a mixture of 2,4Toluene diisocyanate and 2,6Toluene diisocyanate .It is present in a ratio of 80:20 i.e. 2,4Toluene diisocyanate: 2,6Toluene diisocyanate. Our target substance was present in a ratio of 20.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Weight at study initiation: male153-171 g and female-128-144 g
- Fasting period before study:
- Housing: No data available.
- Diet (e.g. ad libitum): No data available.
- Water (e.g. ad libitum): No data available.
- Acclimation period: No data available.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 -26°C
- Humidity (%):50-63 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark ( 150-300 lux)
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- No data available
- Doses:
- 0 and 2000 mg/kg
- No. of animals per sex per dose:
- Total no. of animals-20
0 mg/kg- 5 male and 5 female
20 mg/kg-5 male and 5 female - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed daily and weight was taken on 0,7 and 14 day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and pathology were observed - Statistics:
- No data available
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No deaths occurred of either sex during the observation period.
- Clinical signs:
- other: Hypo activity and loose stool was observed in both sexes as an effect of the test substance.
- Gross pathology:
- No significant change was observed in both sexes of treated group compared to control.
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 value was considered to be >2000 mg/kg in male and female Crj:CD(SD) rats for Toluene diisocyanate.
- Executive summary:
In a acute oral toxicity Crj:CD (SD) male and female rats were treated with Toluene diisocyanate in the concentration of 0 and 2000 mg/kg bw orally by gavage in corn oil and observed for 14 days. No effect on survival of treated male and female rats was observed as compared to control. In addition, no effect on body weight and gross pathology of treated male and female rats were observed as compared to control. Therefore, LD50 was considered to be > 2000 mg/kg bw when Crj:CD (SD) male and female rats were treated with Toluene diisocyanate orally by gavage.
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