Registration Dossier
Registration Dossier
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EC number: 604-102-1 | CAS number: 13893-53-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets scientific standards, is well documented and is accepted for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
- Reference Type:
- publication
- Title:
- Robust Summary for Aminoalkylnitrile Category
- Author:
- US EPA HPVIS
- Year:
- 2 006
- Bibliographic source:
- Doc ID: 201-16274
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Rabbits individually quarantined 3 days prior to test. One day prior to test, the animals are shaved. Test substance applied to clipped site and held in place by a plastic wrap and napped filter cloth. Test site is wiped clean after 24 hour exposure period. Animals are observed for physical condition and mortality on the day of test material application and twice daily for 14 days.
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- 2-amino-2,3-dimethylbutanenitrile
- Cas Number:
- 13893-53-3
- Molecular formula:
- C6H12N2
- IUPAC Name:
- 2-amino-2,3-dimethylbutanenitrile
- Details on test material:
- Purity: >95%
brown liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Rabbits individually quarantined 3 days prior to test. Animals fed ad libitum during quarantine and study. One day prior to test, the
animals are shaved.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- Neat 2-amino-2,3-dimethylbutanenitrile was applied at doses of 12.5, 25, 50, 100, and 200 mg/kg to the shaved skin of 5 groups of five male albino rabbits then covered with an occlusive wrap for 24 hours. Test site is wiped clean after 24 hour exposure period.
- Duration of exposure:
- Animals were observed for 14 days.
- Doses:
- 12.5, 25, 50, 100, and 200 mg/kg.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 23 mg/kg bw
- 95% CL:
- 16 - 32
- Mortality:
- 12.5 mg/kg: 0/5
25 mg/kg: 3/5
50 mg/kg: 5/5
100 mg/kg: 5/5
200 mg/kg: 5/5 - Clinical signs:
- other: Signs of toxicity observed in all animals at all dose levels included ataxia and prostration.
- Gross pathology:
- Not performed.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
