Registration Dossier
Registration Dossier
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EC number: 284-183-4 | CAS number: 84803-57-6
Acute Toxicity: oral
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:
- other: GLP compliant guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (4-tert-butyl-2,6-dimethylphenyl)acetonitrile
- EC Number:
- 284-183-4
- EC Name:
- (4-tert-butyl-2,6-dimethylphenyl)acetonitrile
- Cas Number:
- 84803-57-6
- Molecular formula:
- C14H19N
- IUPAC Name:
- 2-(4-tert-butyl-2,6-dimethylphenyl)acetonitrile
- Details on test material:
- Name of the test substance used in the study report: 2,6-Dimethyl-4-tert.-butylbenzylcyanid
Constituent 1
Test animals
- Species:
- rat
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% CMC solution in doubly distilled water
- Details on oral exposure:
- - Concentrations used: 3 and 20 g/100 mL
- Administration volume: 10 mL/kg - Doses:
- 300 and 2000 mg/kg/bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: No abnormalities
- Gross pathology:
- Organs without particular findings
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this test, the LD50 was determined to be greater than 2000 mg/kg bw for female rats.
- Executive summary:
In GLP compliant study performed according to OECD guideline 423, six female rats per dose were exposed to 300 or 2000 mg/kg bw of the test substance dissolved in 0.5% CMC solution in doubly distilled water. After an observation period of 14 days the surviving animals were necropsied. No mortality occurred. No clinical signs were observed and gross pathology of the organs showed no particular findings.
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