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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 948-047-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- The exposure period was for 24 hours as opposed to 4 hours as stated in the TG.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fatty acids, C16-18, esters with ethylene glycol
- EC Number:
- 292-932-1
- EC Name:
- Fatty acids, C16-18, esters with ethylene glycol
- Cas Number:
- 91031-31-1
- Molecular formula:
- C18H36O3, C20H40O3, C34H66O2, C36H70O4, C38H74O2
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Olive oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml of a 40% solution.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Six
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: All animals
- Time point:
- 24/48 h
- Score:
- 0.29
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary dermal irritation index was 0.29 following dermal application of the subtance. Therefore, the substance is not expected to be a skin irritant under the conditions of this study.
- Executive summary:
In an in vivo skin irritation study New Zealand White rabbits (n=6) were exposed to the substance by application of a 40% solution on clipped skin. The substance was left on the skin for 24 hours. The treated skin was examined at 1 hour, 24- and 48 hours post-exposure. The substance produced slight erythma at 24 hours post-exposure. At 72 hours there was no erythma or oedema. The primary dermal irritation index was 0.29 and therefore the substance is not expected to be a skin irritant under the conditions of this study.
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.
