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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 480-190-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 2004/73/EG, B.5; OECD 405 (2002)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Nature of substance: melted substance (<50°C)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ML
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 27, 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
Any other information on results incl. tables
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with
minimal conjunctival irritation in all treated eyes at the 24-hour observation. Minimum
conjunctival irritation was noted in one treated eye at the 48-hour observation.
Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye
appeared normal at the 72-hour observation.
The test material produced a maximum group mean score of 9.3 and was classified as a
MILD IRRITANT (CLASS 4 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 EU labelling
regulations Commission Directive 2001l59/EC.
The test material does not meet the criteria for classification according to GHS classification
scheme.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 9.3 and was classified as a
MILD IRRITANT (CLASS 4 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 EU labelling
regulations Commission Directive 2001l59/EC.
The test material does not meet the criteria for classification according to GHS classification
scheme.
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.
