Registration Dossier
Registration Dossier
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EC number: 811-477-7 | CAS number: 1446134-16-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Aug - 07 Sep 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-chloro-2-[3-(2-chloroacetyl)-4,5-dihydro-1,2-oxazol-5-yl]phenyl methanesulfonate
- EC Number:
- 811-477-7
- Cas Number:
- 1446134-16-2
- Molecular formula:
- C12H11Cl2NO5S
- IUPAC Name:
- 3-chloro-2-[3-(2-chloroacetyl)-4,5-dihydro-1,2-oxazol-5-yl]phenyl methanesulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD/Crl:CD(SD)
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropyl methylcellulose
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per step
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Oral administration of 2000 mg/kg bw test substance did not induce mortality in female rats and was not associated with clinical signs of toxicity, impairment of body weight development or gross and histopahtological abnormalities. The LD50 value was > 2000 mg/kg bw. No classification is required according to CLP/EU GHS criteria.
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