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
- Study period:
- 17 March 1995 to 07 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers
- Cas Number:
- 61788-89-4
- Molecular formula:
- C36H64O4 (representative)
- IUPAC Name:
- Fatty acids, C18-unsatd., dimers
- Reference substance name:
- Fatty acids, tall-oil
- Cas Number:
- 61790-12-3
- Molecular formula:
- C18H32O2 (representative)
- IUPAC Name:
- Fatty acids, tall-oil
- Reference substance name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- Cas Number:
- 61791-39-7
- Molecular formula:
- C22H40N2O (representative)
- IUPAC Name:
- 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
- Specific details on test material used for the study:
- Description: reddish-brown liquid
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Test animals approximately 5 weeks of age; 6 weeks old at study start
- Animals were quarantined 9 days prior to test article administration
- Housing: polycarbonate cages
- Diet: Purina Certified Rodent Chow No. 5002
- Water: Tap water, analyzed at least annually
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Single dose
- Doses:
- 2 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- All animals observed twice on Test Day 1 approximately 1 and 3 hours following test article administration, and once daily thereafter until necropsy on Day 15.
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
- Clinical signs:
- other: No adverse signs
- Gross pathology:
- No gross lesions observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the tes material is not toxic to male and female Sprague-Dawley (SD) rats when administered as a single oral dose of 2000 mg/kg
- Executive summary:
A single oral dose of 2 g/kg (2000 mg/kg), formulated in corn oil, was administered to a group of five male and five female Sprague-Dawley (SD) rats. All animals of each sex survived until the time of terminal sacrifice on Day 15. No clinical signs of toxicity were noted in any animal and no abnormal findings were noted at necropsy. Based on the results of this study, the test material is not toxic to male and female Sprague-Dawley (SD) rats.
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