Registration Dossier
Registration Dossier
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: 908-381-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD Guideline n° 405 and in compliance with UK GLP standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- reaction mass of calcium sulfate,magnesium dihydroxide,calcium carbonate
- IUPAC Name:
- reaction mass of calcium sulfate,magnesium dihydroxide,calcium carbonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of the test material
- Duration of treatment / exposure:
- the test material was not removed
- Observation period (in vivo):
- 1, 24, 48, 72 hours and after 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 16.3
- Max. score:
- 17
- Reversibility:
- fully reversible
- Remarks:
- All treated eyes appeared normal at the 7-day observation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 15.7
- Max. score:
- 29
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 9.7
- Max. score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 7.7
- Max. score:
- 15
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to Commission Directive 93/21/EEC.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance should not be classified for eye irritation/corrosion using the criteria of Directive 67/548/EEC (DSD) or the criteria of Regulation No 1272/2008 (CLP).
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.
