Registration Dossier
Registration Dossier
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EC number: 212-572-0 | CAS number: 827-52-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study according to international guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cyclohexylbenzene
- EC Number:
- 212-572-0
- EC Name:
- Cyclohexylbenzene
- Cas Number:
- 827-52-1
- Molecular formula:
- C12H16
- IUPAC Name:
- cyclohexylbenzene
- Details on test material:
- - Name of test material (as cited in study report): MCS-2805
- Description: clear colourless liquid
- Composition: cyclohexylbenzene: 92.6%; bicyclohexyl: 6.9%
- Lot No.: ABDR-016
- Date received: 2001-08-06
- Storage conditions: room temperature, in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum (LABDIET 5322, PMI Nutrition International, Nottingham, UK)
- Water: ad libitum
- Acclimation period: ≥ 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70
- Air changes (per hr): ≥ 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize JH (1977)
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
Any other information on results incl. tables
Individual scores and individual total scores for ocular irritation.
Rabbit n° and sex |
61 Male |
155 Male |
156 Female |
|||||||||
Time after treatm. |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
Cornea E = Degree of opacity F = Area of cornea |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Score (E x F) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae A = Redness B = Chemosis C = Discharge |
2 1 2 |
1 0 1 |
0 0 0 |
0 0 0 |
2 1 2 |
1 0 1 |
0 0 0 |
0 0 0 |
2 1 1 |
1 0 0 |
0 0 0 |
0 0 0 |
Score (A + B + C) x 2 |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
8 |
2 |
0 |
0 |
Total Score |
10 |
4 |
0 |
0 |
10 |
4 |
0 |
0 |
8 |
2 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced an overall average score of 3.3 after 1 h.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit.
A single application of the test material to the non-irrigated eye of 3 rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48 h observation. The test material produced an overall average score of 3.3 after 1 h.
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