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Registration Dossier
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EC number: 701-199-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline study, some restrictions in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Five male and five female animals were used for each of 5 oral dosage levels and held for a 14-day observation period
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Sample number: 41105731
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Madison WI
- Age at study initiation: 7 weeks
- Weight at study initiation: 202-300 g
- Fasting period before study: overnight
- Housing: 5/cage
- Diet: ad libitum, Purina Rodent Chow
- Water: ad libitum
- Acclimation period: 7 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10.0 ml/kg bw - Doses:
- Males: 2.55, 2.75, 3.00, 3.57, 5.00 g/kg
Females: 1.30, 1.82, 2.55, 3.57, 5.00 g/kg - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality: 1, 2.5 and 4 hrs after administration and daily thereafter. Weighing: before administration and on day 7 and 14
- Gross necropsy of animals which died: yes
- Gross necropsy of survivors performed: no - Statistics:
- Thakur, A.K., and Fezio, W.L., 1891. A computer program for estimating LD50 and its confidence limits using a modified Behrens-Reed-Muench cumulant method. Drug and Chemical Toxicology, 297-305.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 2.72 other: g/kg bw
- 95% CL:
- 2.52 - 2.93
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2.15 other: g/kg bw
- 95% CL:
- 1.61 - 2.89
- Mortality:
- Males: 2.55 g/kg: 0/5 (0 of 5 animals); 2.75 g/kg: 3/5; 3.57-5.00 g/kg: 5/5
Females: 1.30 g/kg: 0/5; 1.82 g/kg: 2/5; 2.55 g/kg: 3/5; 3.57-5.00 g/kg: 5/5 - Clinical signs:
- other: not reported
- Gross pathology:
- In the animals which died histopathological lesions were observed mainly in the gastro-intestinal tract, primarily in the stomach.
Applicant's summary and conclusion
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