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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 931-242-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- Federal Register, Vol 38, No . 187 (27 .09 .73), § 1500 .42 and
Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin-, Texas 1959, p .51 - GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- Vitamin A acetate Mutterlaugenoel
Vitamin A Acetat-Mutterlaugenöl, 1.50 mio IU/g (ca. 520 mg Vitamin A acetate/g or 52%); 40% all-trans retinol acetate (CAS No. 127-47-9), remainder isomeric retinol acetate(s); no further data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye of each rabbit
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: not rinsed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
RS-Freetext:
Primary irritation score was 2.6 (possible maximum score = 110).
The test substance produced some signs of irritation; however, the severity
of these symptoms do not imply a classification as "irritant to the eyes").
Table: Individual Draize scores for cornea (opacity, area involved), iris, and
conjunctivae (redness, swelling, discharge) and total individual scores.
animal cornea iris conjunctivae total
no op. area redn. swell. disc. score
---------------------------------------------------------
24-hour reading
1 0 0 0 1 0 1 4
2 0 0 0 1 0 1 4
3 0 0 0 2 0 1 6
4 0 0 0 1 0 0 2
5 0 0 0 1 0 1 4
6 0 0 0 1 0 0 2
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 0 0 0 1 0 1 4
2 0 0 0 1 0 0 2
3 0 0 0 1 0 1 4
4 0 0 0 1 0 0 2
5 0 0 0 1 0 1 4
6 0 0 0 1 0 0 2
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 0 0 0 0 0 0 0
2 0 0 0 1 0 2 2
3 0 0 0 1 0 2 2
4 0 0 0 1 0 2 2
5 0 0 0 0 0 0 0
6 0 0 0 0 0 0 0
---------------------------------------------------------
Total mean score = 2.6 (mean of 6)
---------------------------------------------------------
total individual score = [corneal opacity x area x 5] + [iris x 5] +
[(redness + swelling + chemosis) x 2]; maximum total individual score = 110
Mean scores 24 - 72 h reading
Animal Cornea Iris Conjunctivae
Redness Chemosis
---------------------------------------------
1 0 0 0.7 0
2 0 0 1.0 0
3 0 0 1.3 0
4 0 0 1.0 0
5 0 0 0.7 0
6 0 0 0.7 0
Mean scores 24 - 72 h reading
Animal Cornea Iris Conjunctivae
Redness Chemosis
---------------------------------------------
1-6 0 0 0.9 0
Applicant's summary and conclusion
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.
