Registration Dossier
Registration Dossier
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EC number: 480-410-8 | CAS number: 13482-23-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May - July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1967
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 480-410-8
- EC Name:
- -
- Cas Number:
- 13482-23-0
- Molecular formula:
- Hill formula: C7H12O2 CAS formula: C7H12O2
- IUPAC Name:
- 4-methoxycyclohexan-1-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.76
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.53
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Conclusions:
- According to classification criteria the test item is irritating to eyes with full reversibility within 14 days.
There were no systemic intolerance reactions. - Executive summary:
The irritant / corrosive effects of the test item were tested on the eye of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002; EEC Directive 67/548 Annex V - Method B.5. (1967) in its current version, and the principles of the EPA Health Effects Test Guidelines (OPPTS 870.2400), United States, EPA 712-C-98-195 (1998), with the exception that recognized differences exist between OECD - Guideline 405 and EPA - Guideline OPPTS 870.2400.
According to classification criteria the test item is irritating to eyes with full reversibility within 14 days.
There were no systemic intolerance reactions.
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