Registration Dossier
Registration Dossier
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EC number: 239-360-0 | CAS number: 15323-35-0
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:
- 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:
- yes
Test material
- Reference substance name:
- 1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone
- EC Number:
- 239-360-0
- EC Name:
- 1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone
- Cas Number:
- 15323-35-0
- Molecular formula:
- C17H24O
- IUPAC Name:
- 1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Description: White, crystalline solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, The Netherlands
- Weight at study initiation: 2500 - 3500 g
- Housing: Individually in suspended, galvanized cages, fitted with wire-mesh floor and front
- Diet: Standard laboratory rabbit diet, ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 40-70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other untreated eye
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- The eyes of the rabbits were examined 24 hours prior to testing and only those animals without observable eye defects were used. 0.1 g of the undiluted test material was allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower lid were then carefully closed and subsequently held together for about 1 second. The eyes were not washed out following administration. Ocular reactions were judged using the scoring scale from OECD guideline 405. Eye effects were examined 1 hour, 24, 48, 72 hours and 7 days.
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:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- After one hour the eye effects observed in all three rabbits consisted of moderate redness and swelling of the conjunctivae. During the 7-day observation period these eye effects cleared partly or completely. After 7 days, only slight redness of the conjunctivae was observed in 2 out of 3 rabbits. On the basis of observations in earlier experiments with comparable effects it is expected that these effects are fully reversible.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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