Registration Dossier
Registration Dossier
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EC number: 451-540-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- - Directive CEE
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: Sprague-Dawley (SPF) ; 5 /sex – 1 treated group
- Age/Bodyweight at start: 6-week old; 175 +/-6g (males); 148+/-6g (females)
- Temperature: 21+/-2°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 5 rats/sex/cage, on sawdust
- Food and water ad libitum, except before dosing
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % MC (Methyl cellulose)
- Details on oral exposure:
- - overnight fasting before dosing
- dose volume: 10ml/kg - Doses:
- 2000 mg / kg.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - 2-week observation period after dosing
- monitoring: clinical signs and mortality, bodyweight
- terminal kill on Day 15: macroscopic examination
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- no clinical signs
- Body weight:
- isolated body weight loss in 1/5 females
- Gross pathology:
- no macroscopic abnormality
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Lethal dose > 2000mg/kg per os.
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