Registration Dossier
Registration Dossier
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EC number: 453-490-7 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only 2 male and 2 female rats were used, details on test substance not documented.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : Only two male and two female animals used
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C5-10, esters with pentaerythritol
- EC Number:
- 270-291-9
- EC Name:
- Fatty acids, C5-10, esters with pentaerythritol
- Cas Number:
- 68424-31-7
- Molecular formula:
- C25H44O8 to C45H84O8
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alderley Park SPF albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: males: 215 g - 237 g; females: 145 g - 163 g
- Fasting period before study: 24 h
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Duration of observation period following administration: not stated
- Other examinations performed: body weight, macroscopic abnormalities (post mortem)
Results and discussion
Effect levels
- 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:
- other: No significant signs of toxicity in females but males showed slight toxicity following a 2000 mg/kg bw dose.
- Body weight:
- other body weight observations
- Remarks:
- Initial loss of weight (due to predose fasting) with normal weight gain after dosing.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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