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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-020-4 | CAS number: 9005-67-8 1 - 6.5 moles ethoxylated
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Authoritative database
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Acute oral toxicity by using test chemical
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- ChemIDplus
- Reference Type:
- other: Data is from authoritative database
- Title:
- Acute oral toxicity of test chemical in rats
- Author:
- RTECS
- Year:
- 2 018
- Bibliographic source:
- RTECS (registry of toxic effect of chemical substance data base), 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Acute oral toxicity of test chemical in rats
- GLP compliance:
- not specified
- Test type:
- other: not specified
Test material
- Reference substance name:
- Sorbitan monostearate, ethoxylated
- Cas Number:
- 9005-67-8
- Molecular formula:
- C64H126O26
- IUPAC Name:
- Sorbitan monostearate, ethoxylated
- Test material form:
- solid
- Details on test material:
- IUPAC name: Sorbitan monostearate, ethoxylated
Smiles: CCCCCCCCCCCCCCCCCC(=O)OCCOC[C@H]([C@@H]1[C@H]([C@@H](CO1)OCCO)OCCO)OCCO
InChI: 1S/C32H62O10/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-30(36)40-25-24-37-26-28(38-21-18-33)32-31(41-23-20-35)29(27-42-32)39-22-19-34/h28-29,31-35H,2-27H2,1H3/t28-,29-,31+,32-/m1/s1
- Name of test material :Polysorbate 60
- Molecular formula :C64H126O26
- Molecular weight :606.8318 gm/mol
- Substance type:Organic
- Physical state:Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- >60000 mg /kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 60 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality observed
- Mortality:
- No mortality observed at 60000 mg/kg bw dose
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral LD50 value was considered to be >60000 mg/kg bw when rats were treated with test chemical via oral route.
- Executive summary:
Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 60000 mg/kg bw. The test chemical was administered via oral unspecified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. No mortality and clinical signs were observed during 14 days observation period. Therefore, LD50 value was considered to be >60000 mg/kg bw, when rats were treated with test chemical via oral route.
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.
