Registration Dossier
Registration Dossier
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EC number: 943-381-7 | CAS number: 2156594-85-1
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: Scientifically well performed and well documented. Guideline study: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- Fatty acids, C18-unsatd., compd. with 2-propanol, 1,1’-iminobis-, N-C12-18-(even numbered) alkyl derivs.
- Cas Number:
- 2156594-85-1
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C18-unsatd., compd. with 2-propanol, 1,1’-iminobis-, N-C12-18-(even numbered) alkyl derivs.
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- a single application of 0.1 ml of test substance into the eye
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registration substance induced transient conjunctivae redness and chemosis in rabbits. According to EU criteria, no classification is warranted for the registration substance.
- Executive summary:
The registration substance was investigated for its eye irritation property according to Guideline OECD 405. Three rabbits were used. The undiluted registration substance was applied into eye. Conjuctivae redness of scores up to 2 and chemosis of scores of 1 were observed within the first three days of the observation period. The observed effects were fully reversible within 7 days of observation period.
No classificaiton is warranted for the registration substance according to the EU criteria.
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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