Registration Dossier
Registration Dossier
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EC number: 238-620-0 | CAS number: 14576-08-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- See justification of information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 February 1980 - 27 February 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- An in vitro eye irritation was not conducted because information from an OECD TG 405 was availabel carried out before 2016.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-(1-methoxy-1-methylethyl)-1-methylcyclohexene
- EC Number:
- 238-620-0
- EC Name:
- 4-(1-methoxy-1-methylethyl)-1-methylcyclohexene
- Cas Number:
- 14576-08-0
- Molecular formula:
- C11H20O
- IUPAC Name:
- 4-(2-methoxypropan-2-yl)-1-methylcyclohex-1-ene
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0 – 3.5 kg
- Housing: singly under standard laboratory conditions (as specified in “guide for the care and use of laboratory animals” DHEW Publication No. 78-23, Revised 1978). The suspended pans beneath the cage were littered with prepared bedding (Easi Litter)
- Diet: 100 g Purina rabbit Chow supplemented by whole oats daily
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Single instillation to the right eye
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: substance was not removed
SCORING SYSTEM: according to the Method of Draize at 24, 48 and 72 hours and at 4 and 7 days after dosings.
TOOL USED TO ASSESS SCORE: fluorescein
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, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- 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
Applicant's summary and conclusion
- Interpretation of results:
- other: criteria are not met
- Remarks:
- according to EU CLP (1272/2008 and its updates)
- Conclusions:
- Under the test conditions the test substance is not considered to be an eye irritant in accordance with EU CLP and GHS criteria.
- Executive summary:
To determine the eye irritation potential 0.1 mL of the test substance was instilled once into the right eye of each of six New Zealand White rabbits. Both eyes were examined before testing, at 24, 48 and 72 hours and at 4 and 7 days. The irritation was scored by the method of Draize. The corneal opacity, iritis and chemosis scores were determined to be 0 for all animals. The conjunctival redness scores were determined to be 0.66, 0.66, 0.66, 0.33, 0, and 0.33 for animal 1, 2, 3, 4, 5, and 6, respectively. Based on these scores the test substance was considered not to be irritating to the eyes in accordance with EU CLP and GHS criteria..
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