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Registration Dossier
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EC number: 286-075-2 | CAS number: 85186-89-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Jan - 01 Feb 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limited data on test material given
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane
- EC Number:
- 286-075-2
- EC Name:
- Fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane
- Cas Number:
- 85186-89-6
- Molecular formula:
- C30H56O6, C60H116O6 and C60H110O6
- IUPAC Name:
- Fatty acids, C8-18 (even numbered) and C18-unsatd., esters with trimethylolpropane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd/Cpb:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: males: 212 - 220 g; females: 165 - 205 g
- Housing: 5 animals per Makrolon type III cage
- Fasting period before study: 16 h before treatment until 3 - 4 h after dosing
- Diet: Ssniff-R Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany, ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.15 mL/kg
- Doses:
- 2000 mg/kg bw (taking into account the specific gravity of 0.93 g/mL)
- 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: 10 min, 1 h, 6 h, 24 h, and thereafter once daily up to 14 days; weighing: Days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology
Results and discussion
- Preliminary study:
- Single application of 2000 mg/kg bw in 2 female rats.
No deaths occurred.
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 clinical sings of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
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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