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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 291-759-9 | CAS number: 90480-27-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-10-05 to 1983-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA, USA
- Age at study initiation: not stated
1 rabbit per cage, stainless steel with elevated wire mesh flooring.
temperature - 60 - 75 degrees F, 40 - 45% humidity, 12 hr ligh/dark photoperiod. Ad libitum Wayne 15% rabbit ration & tap water.
Rabbits acclimated prior to dosing
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye acted as control
- Amount / concentration applied:
- 0.1 g ground material
- Duration of treatment / exposure:
- 7 day exposure and observation period.
- Observation period (in vivo):
- 1, 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: none specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.78
- Max. score:
- 3
- Reversibility:
- other: reversible in 5/6 rabbits.
- Remarks on result:
- other: Score of 1 for redness in one animal for all observations. Redness reversible in 5/6 rabbits by 72 hours or 4 days. 2/5 rabbits which showed reversible effects had score of 1 at 7 day observation. The material was not washed from the eye.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: 3/6 rabbits which showed reversible effects at the Day 4 observation had a score of 1 at the 7 day observation. The test material was not washed from the eye.
- Irritant / corrosive response data:
- No other observations were recorded
- Other effects:
- No other observations were recorded
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not an irritant to the eyes of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008
- Executive summary:
Test Guidance
In a study similar to US EPA OPP 81-4, ground test chemical (0.1 g) was placed into the conjunctival sac of one eye of each of 6 New Zealand White rabbits. The untreated eye acted as a control. The eyes were not washed after instillation. Treated eyes were examined at 1, 2, 3, 4 and 7 days after treatment.
Results
Slight conjunctival effects (redness and chemosis) were noted in all 6 animals. Effects were reversible by the 4 -day observation except for redness in one animal which persisted to the 7-day observation. Effects which had reversed at the 4 -day observation reoccurred at the 7 -day observation (2/5 animals (redness) and 3/5 animals (chemosis). This was considered to be due to the presence of the test material throughout the full 7 -day period in comparison to the current OECD guideline which requires washing of the eye at the 1 hour exposure observation if the material has not been removed by physiological mechanisms.
Conclusion
The test material is not an irritant to the eye of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008
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.
