Registration Dossier
Registration Dossier
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EC number: 212-855-9 | CAS number: 873-94-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1985-07-09 to 1985-07-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP Guideline study
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:
- 3,3,5-trimethylcyclohexan-1-one
- EC Number:
- 212-855-9
- EC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Cas Number:
- 873-94-9
- Molecular formula:
- C9H16O
- IUPAC Name:
- 3,3,5-trimethylcyclohexan-1-one
- Details on test material:
- 3,3,5-trimethylcyclohexanone of Hüls AG, no further data
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
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male/female
- Weight at study initiation: 2.3 - 2.7 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tab water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 +/- 1 °C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount applied: 0.1 ml
- undiluted - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: rinsed after (see exposure time)
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 8, and 10 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 5.83
- Max. score:
- 110
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24,m 48, 72 hours
- Score:
- 0.05
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.28
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.50
- Iris: 0.06
- Conjunctivae (Redness): 0.89
- Conjunctivae (Chemosis): 0.28
- Overall irritation score: 5.83/110
REVERSIBILITY: complete within 10 days - Other effects:
- OTHER EFFECTS: vocalization and defense reaction in 1 animal just after treatment
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Conclusions:
- Based on a mean irritation score of 5.83/110 3,3,5-trimethylcyclohexanone is not irritant to the eye in this study.
- Executive summary:
In a primary eye irritation study according to OECD 405, 0.1 ml of undiluted 3,3,5-trimethylcyclohexanone was instilled into the conjunctival sac of one eye per animal of 3 rabbits/sex for 72 hours followed by rinsing. Animals then were observed for 10 days. Irritation was scored by the method of Draize (1959).
Directly after treatment one female animal showed vocalization and defense reaction. The overall irritation score was 5.83/110.
In this study, 3,3,5-trimethylcyclohexanone is not an eye irritant.
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