Registration Dossier
Registration Dossier
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EC number: 947-930-1 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-05 to 2003-05-27
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Tris(2-ethylhexyl) 2-hydroxypropane-1,2,3-tricarboxylate
- EC Number:
- 230-457-3
- EC Name:
- Tris(2-ethylhexyl) 2-hydroxypropane-1,2,3-tricarboxylate
- Cas Number:
- 7147-34-4
- Molecular formula:
- C30H56O7
- Test material form:
- other: Colourless liquid
- Details on test material:
- Bernel Ester TCC (Tricapryl Citrate) Lot #1585
100%
Test substance was expected to be stable for the duration of testing
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 5 female rats, 9-10 weeks old (160-192g) at experimental start. Housed singly. Temperature range 20-24C with 12/12 hour light/dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Animals were fasted overnight night prior to receiving a single oral dose of test substance at 2,000 mg/kg bw. Feed was replaced approximately 3-4 hours after dosing.
- Doses:
- single oral dose at 2,000 mg/kg bw
- No. of animals per sex per dose:
- 5 female
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: None observed
- Gross pathology:
- unremarkable
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Under the conditions of this study the test substance has an acute oral LD50 of > 2,000 mg/kg bw in female rats.
- Executive summary:
5 female rats were fasted overnight night prior to receiving a single oral dose of test substance at 2,000 mg/kg bw. Feed was replaced approximately 3-4 hours after dosing. All animals survived and gained bodywieght. No signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour were observed. Under the conditions of this study the test substance has an acute oral LD50 of > 2,000 mg/kg bw in female rats.
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