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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 810-432-9 | CAS number: 1487263-87-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,3-bis(acetyloxy)propyl 8-(3-octyloxiran-2-yl)octanoate
- Cas Number:
- 1487263-87-5
- Molecular formula:
- C25H44O7
- IUPAC Name:
- 2,3-bis(acetyloxy)propyl 8-(3-octyloxiran-2-yl)octanoate
- Test material form:
- other: oily liquid
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: RECONSTRUCTED HUMAN EPIDERMIS (RHE)
Results and discussion
Any other information on results incl. tables
INTERPRETATION OF RESULTS According to EU classification, the irritancy potential of test substances is predicted to distinguish between R38 skin irritating and no-label (non-skin irritating) test substances OECD404 and Regulation (EC) No 1272/2008. In this study the irritancy potential of test substances is predicted by mean tissue viability of tissues exposed to the test substance. The test substance is considered to be irritant to skin (R38), if the mean relative viability after 10 minutes exposure and 42 hours post incubation is less or equal to 50% of the negative control. |
ACCEPTABILITY CRITERIA |
The
negative control data meet the acceptance criteria if the mean OD value
from 3 tissue replicates at 570 nm is: OD>1.2
The positive control data meet the acceptance criteria if the mean viability, expressed as % of the NC, is < 40%. In both cases, the standard deviation value will be considered valid if it is < 18% according to the performance standard (ECVAM SIVS, 2007). |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
