Registration Dossier
Registration Dossier
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EC number: 220-668-9 | CAS number: 2855-27-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-Jan-1985 to 11-Jan-1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Cyclohexane-1,2,4-triyltris(ethylene)
- EC Number:
- 220-668-9
- EC Name:
- Cyclohexane-1,2,4-triyltris(ethylene)
- Cas Number:
- 2855-27-8
- Molecular formula:
- C12H18
- IUPAC Name:
- 1,2,4-triethenylcyclohexane
- Details on test material:
- IUCLID4 Test substance: other TS: 1,2,4-Trivinylcyclohexan; purity: 99.5 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: kleine weiße Russen, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Species/Strain: Rabbit (Kleine weiße Russen), Chbb-SPF
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: single housing
- Diet: K4 Alleindiät für Kaninchen, SSniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days befor the first test-substance application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1°C
- Humidity (%): 60 +/-5 %
- Air changes (per hr): 15fold
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml, undiluted
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male / 3 female
- Details on study design:
- Undiluted test substance (0.1 ml) was placed in the conjunctival sac of one eye, the other served as control. Test substance was not removed. Evaluation of results 1, 24, 48 and 72 hours after instillation of the test substance.
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:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- 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:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Following the instillation of the test substance into the rabbit eye no effects on cornea and iris were observed. In all 6 test animals the conjunctivae was reddened one hour after instiillation and a slight swelling and discharge were observed. After 24 hours, only a slight reddening could still be observed in 3 animals. All findings were resolved after 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating to the eye. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
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