Registration Dossier
Registration Dossier
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EC number: 270-560-0 | CAS number: 68443-84-5
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:
- key study
- Study period:
- 07 Dec - 26 Mar 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions (no data on analytical purity).
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- secondary source
- Title:
- Test Plan for the polyol esters category of the aliphatic esters chemicals
- Author:
- US-EPA (American Chemistry Council’s Aliphatic Esters Panel)
- Year:
- 2 004
- Bibliographic source:
- High Production Volume (HPV)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- no data on analytical purity
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C5-9, hexaesters with dipentaerythritol
- EC Number:
- 267-021-7
- EC Name:
- Fatty acids, C5-9, hexaesters with dipentaerythritol
- Cas Number:
- 67762-52-1
- IUPAC Name:
- 67762-52-1
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow liquid
- Analytical purity: no data
- Lot/batch No.: CRU 98433
- Expiration date of the lot/batch: 05 Nov 2003
- Storage condition of test material: room temperature
- Other: Density: 1.0 g/mL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino Rats (Outbred). Stock: Sprague-Dawley – derived (CD ®) [Crl: CD ® (SD) IGS BR]
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, New York, USA
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 279 – 318 g (males); 204 – 219 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: 2 – 6/ cage during acclimation. Individually housed in suspended and stainless steel cages with wire mesh bottoms during study.
- Diet: Certified Rodent Diet, No. 5002, ad libitum
- Water: automatic watering system, ad libitum.
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24
- 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: 2.0 mL/kg
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality was observed twice daily for 14 days. Clinical signs were observed several times on the day 1, and daily until day 14. Body weights were measured on day 0 (at time of fasting), 1 (just prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes (on day 15)
- Other examinations performed: clinical signs, body weight, food consumption, gross pathology and histopathology
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 clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy examination revealed no substance-related findings.
- Other findings:
- - Histopathology: there were no treatment-related effects on histopathology.
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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