Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 306-248-9 | CAS number: 96690-53-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Sunflower oil, ester with sorbitol
- EC Number:
- 306-248-9
- EC Name:
- Sunflower oil, ester with sorbitol
- Cas Number:
- 96690-53-8
- IUPAC Name:
- sunflower seed oil sorbitol esters
- Test material form:
- liquid
- Details on test material:
- Batch Number: P08/002
Expiry Date: 2010-03-01
Stability of Polyethyleneglycol: stable for hours
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- no effect
- Clinical signs:
- other: One hour after dosing, a slightly ruffled fur was observed in all females which persisted up to the 3- or 5-hour observation. Otherwise, no clinical signs were observed in any animal at any observation time point.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of the registration substance was investigated according to the Guideline OECD 423. Total six females were treated once per gavage at dose of 2000 mg/kg bw. No significant effect was found. The LD50 is higher than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the registration substance was investigated according to the Guideline OECD 423. Total six females were treated once per gavage at dose of 2000 mg/kg bw. No significant effect was found. The LD50 is higher than 2000 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
