Registration Dossier
Registration Dossier
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EC number: 268-596-7 | CAS number: 68130-53-0
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: Comparable to guideline study with acceptable restrictions. Limited documentation but relevant data given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Adopted 24 February 1987
- Deviations:
- yes
- Remarks:
- limited documentation, limited information on test substance given, no necropsy performed
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): [trade name], Trimethylolpropan-C8/10-ester- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 185 g (males), 150 g (females)
- Fasting period before study: 18 h before until 3 h after dosing
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 2 % solution in water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg / kg bw
- 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: observation after 1, 6, 24 and 48 h, weighing after 24 h, 1 and 2 weeks
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/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:
- No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Body weight:
- No effect on body weight was noted.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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