Registration Dossier
Registration Dossier
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EC number: 620-464-3 | CAS number: 1003859-14-0
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:
- 2 013
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:
- [(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amine
- EC Number:
- 620-464-3
- Cas Number:
- 1003859-14-0
- Molecular formula:
- C8H9ClF2N2
- IUPAC Name:
- [(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- 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 (1/6) 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 (6/6), incoordination (3/6) and death (1/6). Surviving animals were symptom free from Day 3.
- Gross pathology:
- Found dead:
In the female 1162, light yellow, liquid material with or without bedding in the stomach, duodenum, jejunum, ileum and cecum were noted at necropsy and were regarded as potentially related to the administration of the test item. Dark red discoloration of the non-collapsed lungs was also noted in this animal at necropsy.
Surviving animals:
In the surviving animals no test-item related macroscopic changes could be noted.
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.
The study result triggers the following classification/labelling:
- EU Directive 1999/45/EC (as amended): none
- Regulation (EC) No 1272/2008 (CLP): none
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