Registration Dossier
Registration Dossier
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EC number: 282-104-8 | CAS number: 84100-23-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-07-14 to 1981-07-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- according to Fed. Reg. No. 38, No. 187, § 1500.42, 1973 (Draize test)
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-(1,1-dimethylethyl)cyclohexyl acrylate
- EC Number:
- 282-104-8
- EC Name:
- 4-(1,1-dimethylethyl)cyclohexyl acrylate
- Cas Number:
- 84100-23-2
- Molecular formula:
- C13H22O2
- IUPAC Name:
- 4-tert-butylcyclohexyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach/Main, FRG
- Weight at study initiation: males (mean): 2.3 kg; females (mean): 2.79 kg
- Housing: individually (Cage made of stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm)
- Diet: ad libitum, Ovator Solikanin 4 mm (Muskator-Werke Düsseldorf, FRG); about 130 g per animal daily
- Water: ad libitum, fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimation period: about 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Test substance was not washed out of the treated eye.
SCORING SYSTEM
According to J .H . Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity, pp. 46 - 59, 1959. Austin Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- A slight and reversible redness of the conjunctivae was observed in all but one animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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