Registration Dossier
Registration Dossier
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EC number: 811-711-8 | CAS number: 14952-06-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize Test
- Version / remarks:
- DRAIZE-TEST: Food Drug Cosmetic Law J. 10: 722, 1955
- Deviations:
- yes
- Remarks:
- Single instillation of 0.1ml of test material into 1 eye of 3 rabbits
- GLP compliance:
- no
Test material
- Reference substance name:
- (E)-methyl non-2-enoate
- EC Number:
- 811-711-8
- Cas Number:
- 14952-06-8
- Molecular formula:
- C10H18O2
- IUPAC Name:
- (E)-methyl non-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1ml
- Observation period (in vivo):
- Observations of the eyes are made immediately after exposure and then 1, 24 48 and 72 hours and then 7 and 14 days later.
- Number of animals or in vitro replicates:
- 3 rabbits per concentration group
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 100% concentration
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 100% concentration
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 30% concentration
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- 30% concentration
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Single application of Neofolione undiluted (at 100% concentration) caused shortlasting conjunctival irritation of the rabbit eye. No alteration of the cornea could be observed macroscopically.
Single application of a 30% solution of Neofolione in Diethylphthalate caused weak conjunctival irritation. No alteration of the cornea could be observed macroscopically.
Single applicatinon of a 10% solution of Neofolione in Diethylphthalate caused weak conjunctival irritation of the rabbit eye. No alteration of the cornea could be observed macroscopically. - Executive summary:
Based on the current guidance (GHS and EU), the scores at 24h, 48h and 72h (Mean score 1.2 for conjunctival redness) do not require Neofolione to be classified as an eye irritant.
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