Registration Dossier
Registration Dossier
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EC number: 231-306-4 | CAS number: 7491-02-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Feb - 18 Feb 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (no necropsy performed, limited documentation)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- lack of study details; no necropsy performed
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diisopropyl sebacate
- EC Number:
- 231-306-4
- EC Name:
- Diisopropyl sebacate
- Cas Number:
- 7491-02-3
- Molecular formula:
- C16H30O4
- IUPAC Name:
- 1,10-bis(propan-2-yl) decanedioate
- Details on test material:
- - Name of test material (as cited in study report): Di-Isopropyl Sebacate
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young adult, not further specified
- Weight at study initiation: 215-267 g
- Fasting period before study: 24 h
- Housing: common cages
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
- Doses:
- 5 mL/kg bw equivalent to 4685 mg/kg bw (recalculated dose based on a density of 0.937 g/mL as given in chapter 4.4)
- 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: observations were made daily for two weeks
- Other examinations performed: eating patterns, behavior patterns
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 685 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Slight diarrhoea was accompanied with wet, oily coats, which normally prevailed within 96 hours. Eating habits and behaviour patterns remained normal throughout the observation period.
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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