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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-568-8 | CAS number: 26266-57-9
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Unsuitable test system (a product containing 4% test substance was evaluated, no data on analytical purity, repeated application).
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Triolate
- Author:
- Elder, R.L., ed.
- Year:
- 1 985
- Bibliographic source:
- Journal of the American College of Toxicology 4(3): 65-121
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- Three products containing 4 % of the test substance were tested for skin irritation in a 21-day cumulative irritancy test.
- GLP compliance:
- no
Test material
- Reference substance name:
- 26266-57-9 [4 %]
- IUPAC Name:
- 26266-57-9 [4 %]
- Details on test material:
- - Name of test material (as cited in study report): Sorbitan palmitate
Constituent 1
Method
- Details on study design:
- Each of the three products, containing 4% test substance, were tested for skin irritation in a 21-day cumulative irritancy test on a varying number of panelists (10 (first product), 15 (second product), 9 (third product)). Skin irritating effects were observed. A value of 630 was given as maximum product irritation score.
Results and discussion
- Results:
- First product: 3 of 10 panelists developed minimal primary irritation toward the end of the patch series, with a product score of 80. The product was assumed to be "slightly irritating".
Second product: An irritation score of 70.7 was observed and the product was assumed to be "slightly irritating".
Third product: Very mild irritation occured in 3 of 9 panelists, the irritation score was 47.78 and the product was assumed to be a "mildly irritating".
Applicant's summary and conclusion
- Conclusions:
- Three products containing 4 % test substance induced mild to slight irritation when administered repeatedly on humans in a 21-day cumulative irritancy test.
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.
