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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-366-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reactive Orange 011:1 - Similar Substance 02
- IUPAC Name:
- Reactive Orange 011:1 - Similar Substance 02
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- 100 mg
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean value 24, 48 and 72h
- Score:
- ca. 0
- Irritant / corrosive response data:
- changes fully reversible within 14 days
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not eye irritant
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.
