Registration Dossier
Registration Dossier
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EC number: 429-080-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24th August - 28th September 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Principles of method if other than guideline:
- An additional group of 1 + 1 was exposed at 200 mg/kg.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 429-080-9
- EC Name:
- -
- Cas Number:
- 198904-85-7
- Molecular formula:
- C17 H21 N3 O2
- IUPAC Name:
- Tert-butyl 2-[4-(2-pyridinyl) phenylmethyl] hydrazine carboxylate
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- Identity of test material same as for substance defined in section 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Vehicle:
- arachis oil
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 500 mg/kg bw; Number of animals: 1; Number of deaths: 0
Male: 200 mg/kg bw; Number of animals: 1; Number of deaths: 0
Male: 50 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 1; Number of deaths: 1
Female: 200 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 50 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: In the preliminary study, the female rat died 3 days after dosing. The male rat had significant clinical signs which resolved after 9 days. Clinical signs became apparent 1 hour after dosing and included hunched
- Gross pathology:
- Effects on organs:
There were no abnormalities recorded at necropsy in the main group. Examinations were not performed in the other groups.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The discriminatory dose was identified as 50 mg / kg bodyweight. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley Strain rat was estimated to be greater than 200mg/kg but less than 2000mg/kg bodyweight.
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