Registration Dossier
Registration Dossier
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EC number: 429-080-9 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th - 22nd July 1999
- 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.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
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:
- other: Rat, Crl:WI(Glx
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Substance was applied to skin moistened with water.
- Duration of exposure:
- 24 hrs
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: No signs of toxicity were observed.
- Gross pathology:
- Effects on organs:
There were no remarkable findings during necropsy considered to be treatment related. - Other findings:
- Signs of toxicity (local):
No dermal effects were noted and other than staining of the snout and anogenital soiling in a small number of animals.
These observations are frequent under the conditions of this type of study and are not considered to be toxicity related.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute dermal toxicity: LD50 > 2000 mg/kg
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