Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
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:
- Other (1981). The method employed in the testing, evaluation, and the scoring of the results was adopted from the U.S. Federal Hazardous Substances Act Regulations study guidelines, 16 CFR, section 1500.3.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Triisodecyl phosphite
- EC Number:
- 246-998-3
- EC Name:
- Triisodecyl phosphite
- Cas Number:
- 25448-25-3
- Molecular formula:
- C30H63O3P
- IUPAC Name:
- Phosphorus acid, triisodecyl ester
- Details on test material:
- - Name of test material (as cited in study report): Triisodecyl phosphite - Commercial, purity: > 97% (Phosphorus content = 6.17 %)- Lot/batch No.: TDPx-003-04070A- Supplier: Borg Warner Company, Parkersburg, WV
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sherman/Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Weight at study initiation: 200 and 300 grams - Fasting period before study: fasted overnight, but were not deprived of water. - Housing: The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR, Part 3. - Diet (e.g. ad libitum): Following administration the animals were allowed food ad libitum - Water (e.g. ad libitum): Following administration the animals were allowed water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The sample was dosed as supplied (described as a colorless to straw-colored liquid).
- Doses:
- 5 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days The LD50 was calculated using the method described by Finney, D.J. 1971. ‘Statistical Methods in Biological Assay, 2nd Edition, London Griffen Press.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Mortality:
- No animals died during the experiment.
- Gross pathology:
- Gross pathological examination revealed no remarkable findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- No signs of acute toxicity at a limit dose of 5 g/kg.
- Executive summary:
Not acutely toxic via the oral route at the limit dose of 5 g/kg. Not classified as acutely toxic.
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