Registration Dossier
Registration Dossier
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EC number: 604-591-1 | CAS number: 147622-83-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo Study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2, 2002 - August 9, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 8-[4-(3,4-difluorophenyl)cyclohex-3-en-1-yl]-1,4-dioxaspiro[4.5]decane
- EC Number:
- 604-591-1
- Cas Number:
- 147622-83-1
- Molecular formula:
- C20H24F2O2
- IUPAC Name:
- 8-[4-(3,4-difluorophenyl)cyclohex-3-en-1-yl]-1,4-dioxaspiro[4.5]decane
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Before application, the test material was ground in a mortar using a pestle.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: approx. 30 - 32 weeks
- Weight at study initiation: 4.37 kg (range from 4.06 to 4.67 kg)
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 20 °C
- Humidity (%): 41 to 77 %.
- Air changes (per hr): --
IN-LIFE DATES: From: day 1 To: day 8
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1g per animal
- Observation period (in vivo):
- 24, 48, and 72 hours, then daily up to day 8 of the experimental part
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according OECD-Guideline
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed at the cornea or iris. The conjunctivae showed redness (score 1) in one animal at the first reading (1 hour after treatment). At later times no signs of irritation were observed. The untreated eyes were unchanged.
- Other effects:
- none
Any other information on results incl. tables
Study design
The test item was tested for its toxicological properties. For the test of primary eye irritation, 0.1 g of the test material was applied into the conjunctival sac of rabbits.
The study started with 1 animal and 2 animals were treated later.
The first examination of the eyes followed 1 hour after instillation. The examinations were performed daily for a further 7 days.
Results
No signs of irritation were observed at the cornea or iris. The conjunctivae showed redness (score 1) in one animal at the first reading. At later times no signs of irritation were observed. The untreated eyes were unchanged.
Conclusion
According to the EEC-Directive 91/325 the test material should not be regarded as an irritant for the eyes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.
- Executive summary:
The study was performed according to OECD 405 under GLP conditions. According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.
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