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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 264-705-7 | CAS number: 64147-40-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The study was run according to an official French method in place at the time and detailed in an earlier publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Etude de tolérances oculaires et cutanée chez le lapin, de différentes matières premières utilisées en cosmétologie et provenant de fabrications diverses (2e partie)
- Author:
- Guillot JP, Giauffret JY and Martini MC
- Year:
- 1 979
- Bibliographic source:
- Int. J Cosmet. Sci. 1: 27-57
Materials and methods
- Principles of method if other than guideline:
- The study was run according to the official French method detailed in an earlier publication (Journal Officiel de la République Française du 21/4/71, Edition Lois et Décrets et du 5/6/73, 6d. Documents administratifs. Methodes officielles d’analyse des cosmetiques et produits de beauté). The eye irritation potential of undiluted castor oil was determined over a period of 24 h in rabbits after single ocular administration.
- GLP compliance:
- no
Test material
- Reference substance name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- IUPAC Name:
- Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Castor oil (CAS N° 8001-79-4, EC N° 232-293-8). Under the SDA nomenclature, the name of this substance is ‘Glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy'
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Undiluted
- Duration of treatment / exposure:
- SIngle application, no rinsing.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 8
- Details on study design:
- The specifications of the test materials were verified analytically before test start.
Instillation of the undiluted test substance in the eyes, then observations at 1 and 24h then 2, 3, 4 and 7 days.
All eyes were examined for direct motor reflex, corneal ulcerations and opacification (under photometer by addition of fluoresceine (2%)), ulcerations and granulous dystrophies (qualitative). Use of slit lamp.
Ocular irritation indices reported only for the 1, 24 and 48h time points. All indices were equal to zero for the other time points.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- :castor oil (stabilised)
- Time point:
- other: 48 h
- Score:
- 0.67
- Max. score:
- 110
- Remarks on result:
- other: No irritation was observed
- Irritation parameter:
- overall irritation score
- Remarks:
- :castor oil (codex)
- Time point:
- other: 48 h
- Score:
- 0.33
- Max. score:
- 110
- Remarks on result:
- other: No irritation was observed
- Irritation parameter:
- overall irritation score
- Remarks:
- :castor oil (pure)
- Time point:
- other: 48 h
- Score:
- 0.17
- Max. score:
- 110
- Remarks on result:
- other: No irritation was observed
- Irritation parameter:
- overall irritation score
- Remarks:
- :castor oil (USP)
- Time point:
- other: 48 h
- Score:
- 1.67
- Max. score:
- 110
- Remarks on result:
- other: No irritation was observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, undiluted castor oil was found to be non-irritating to rabbit eyes.
- Executive summary:
In an ocular irritation test conducted according to official French methods, undiluted castor oil was instilled into the eyes of five rabbits.
Corneas were evaluated over a period of 48 h. No irritation was observed.
Under the test conditions, the substance was found to be non-irritating to the eye.
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.
