Registration Dossier
Registration Dossier
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EC number: 212-595-6 | CAS number: 830-13-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-10-18 to 1983-11-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
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:
- Cyclododecanone
- EC Number:
- 212-595-6
- EC Name:
- Cyclododecanone
- Cas Number:
- 830-13-7
- Molecular formula:
- C12H22O
- IUPAC Name:
- cyclododecanone
- Details on test material:
- cyclododecanone of Hüls AG, purity > 99.5 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: small white Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.3 - 2.8 kg
- Number of animals: 3 males, 3 females
Environmental conditions:
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times/hour
- Light: 12 hour light/dark rhythm
- Diet: K4 complete feed for rabbits (Ssniff, Soest, Germany) ad libitum
- Water: tap water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animals, left eyes remained untreated
- Amount / concentration applied:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: ground in a mortar
- Amount of substance instilled: 0.05 g undiluted
- Vehicle: none - Duration of treatment / exposure:
- not rinsed - no removal of test substance
- Observation period (in vivo):
- Postexposure observation period: 3 weeks
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 10, 13, 16, and 21 days after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 8.04
- Max. score:
- 110
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.94
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 6 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.25
- Iris: 0
- Conjunctivae (Redness): 1.06
- Conjunctivae (Chemosis): 1.00
- Overall irritation score: 8.04/110
REVERSIBILITY: yes - Other effects:
- OTHER EFFECTS: brightness reduced in 2 animals (at 48 hours), very slight circumcorneal injection in 1 animal (days 8-17)
Any other information on results incl. tables
no further information
Applicant's summary and conclusion
- Conclusions:
- According to the outcome of the study with rabbits cyclododecanone is not classified as an eye irritant according to present EU legislation.
- Executive summary:
Eye irritation properties of cyclododecanone were tested with rabbits. The substance showed only very slight irritating effects on eyes and mucosa. Therefore according to present EU legislation cyclododecanone is not classified as an eye irritant.
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