Registration Dossier
Registration Dossier
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EC number: 453-180-1 | CAS number: 1235552-58-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No deviation from OECD-405 guideline, not GLP, but competent authorities agency accreditation of the lab.
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)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- But lab has accreditations from COFRAC and the French Food Safety Agency.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- >= 0 - <= 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- >= 0.3 - <= 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Only some redness during 3 days, but reversible and all other irritation symptoms are absent. Criteria used for interpretation of results: EU
- Conclusions:
- APP-6669 is not irritating to eyes according to OECD-405 test.
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.
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