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EC number: 603-782-7 | CAS number: 133937-72-1
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 07, 1992 - June 12, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- OECD 1981, updated Guideline adopted Februaty 24, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene
- EC Number:
- 603-929-5
- Cas Number:
- 135734-59-7
- Molecular formula:
- C21H29F3O
- IUPAC Name:
- 1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch: E919140
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 28 weeks
- Weight at study initiation:3.24 (3.13 - 3.43) kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 32°C
- Humidity (%): 39 - 61%
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 (1 male & 2 female)
- 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:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in all animals at 24 h which was fully reversibke wihtin 48 hours.
- Other effects:
- none
Any other information on results incl. tables
Study design
To test for primary eye
irritation, the test material was instilled into the conjunctival say of
rabbits. The first examination of the treated eye followed 1 hour after
instillation. The examinations were performed daily for further 7 days.
Results
In the primary eye irritation test, no abnormalities of the cornea and iris were observed. The conjunctivae showed redness (score 1) in all animals at 24 h which was fully reversible within 48 hours. The animal's individual mean scores (considering readings at 24 h, 28 h, and 72 h after installation of the test material) were below 1.0.
Conclusion
According to these results, for regulatory purposes the test material has to be classified as non-irritant for the eyes.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to these results, the test item is not considered to be classified as eye irritant as all animal's individual mean scores (considering readings at 24 h, 48 h and 72 h after installation of the test material) were below 1.0.
- Executive summary:
The study was performed according to OECD 405 under GLP conditions. According to these results, for regulatory purposes there is no need for classification for eye irritation.
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