Registration Dossier
Registration Dossier
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EC number: 671-709-6 | CAS number: 430-67-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU / OECD-guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2-difluoroethan-1-amine
- EC Number:
- 671-709-6
- Cas Number:
- 430-67-1
- Molecular formula:
- C2H5F2N
- IUPAC Name:
- 2,2-difluoroethan-1-amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item caused mortality (2/6) at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Treatment with the test item at the dose level of 2000 mg/kg bw caused decreased activity (6/6), hunched back (6/6), prone position (1/6), piloerection (5/6) and death (2/6).
- Gross pathology:
- Found dead:
Two females (2/6) were found dead on Day 1. Yellow liquid in the digestive content of the stomach and dark red multifocal discoloration of the stomach glandular mucosa found in these animals at necropsy were considered to be associated with administration of the test item.
Surviving animals:
No macroscopic observations were seen in surviving animals dosed at 2000 mg/kg bw and terminated on Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
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