Registration Dossier
Registration Dossier
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EC number: 306-085-3 | CAS number: 95912-89-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 June - 28 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- (adopted Oct. 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- (adopted Dec 2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe interministeriel des produits chimiques
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane
- EC Number:
- 306-085-3
- EC Name:
- Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane
- Cas Number:
- 95912-89-3
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Fatty acids, C8-10 (even numbered), mixed esters with adipic acid and trimethylolpropane
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: 100%
- Physical state: viscous liquid, amber
- Batch no.: ES 090146
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle, France)
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 200 - 209 g
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: individual boxes
- Diet (M20 (SDS)): ad libitum
- Water (tap): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-74
- Air changes (per hr): 15
- 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: 4.99 mL/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed 0.5, 2, 2.5, 3 and 5 h p.a. and daily thereafter, individual body weights were determined on prior to administration and on Day 2, Day 7 and Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy and histopathological examination 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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