Registration Dossier
Registration Dossier
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EC number: 610-847-3 | CAS number: 524709-77-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 21, 2015 - March 15, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted on October 02, 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
- EC Number:
- 610-847-3
- Cas Number:
- 524709-77-1
- Molecular formula:
- C28H26OF6
- IUPAC Name:
- 4-[3,5-difluoro-4-(trifluoromethoxy)phenyl]-3-fluoro-4'-[(1s,4r)-4-propylcyclohexyl]-1,1'-biphenyl
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Before application, the test item was grounded 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 Laboratories, France
- Age at study initiation: 19 - 21 weeks
- Weight at study initiation: 3.32 - 3.96 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): 15.8 to 18.4 °C
- Humidity (%): 44.7 to 71.9 %.
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12h dark : 12h light
IN-LIFE DATES: From: day 1 To: day 4
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- The solid test item was administered at a volume of 0.1 ml. The volume of the solid test item was measured after gently compacting it.
- Observation period (in vivo):
- Any clinical alterations were recorded 1 hour and 6 hours after treatment and then twice daily up to experimental day 4.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: The grades of ocular reaction were evaluated according to Draize (1944), OECD and EC recommendations.
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:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No clinical symptoms and no signs of eye irritation were observed.
- Other effects:
- none
Any other information on results incl. tables
Objective
The objective of the present study was to investigate the eye irritation potential of the test item in rabbits.
Study design
The test item was applied into the conjunctival sac of the left eye of rabbits, the untreated right eye served as control. The degree of eye irritation was evaluated by scoring lesions of conjunctiva, cornea and iris at specific intervals. The first examinations of the eyes followed 1 and 6 hours after treatment. Subsequently, the eyes were investigated twice daily for a further 3 days. In addition, potential systemic effects and the body weight development was determined.The study was performed initially with one animal, followed by the confirmatory test with two further animals.
Results
No mortality occurred during the experimental phase of the study.
The body weight development of the treated rabbits was inconspicuous.
No clinical symptoms and no signs of eye irritation were observed.
Conclusion
Under the conditions of the present study, no eye irritation potential was detected for the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, no eye irritation potential was detected for the test item.
- Executive summary:
The study was performed according to OECD 405 under GLP conditions. Under the conditions of the present study, no eye irritation potential was detected for the test item.
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