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EC number: 213-426-9 | CAS number: 947-19-3
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Sep. 14, 1981 to Sep. 21, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- -comparable to OECD 405, at the last time point of 7 days, one animal still had a redness of conjunctivae score of 1 (observation period should be up to 21 days)
- GLP compliance:
- no
Test material
- Reference substance name:
- Hydroxycyclohexyl phenyl ketone
- EC Number:
- 213-426-9
- EC Name:
- Hydroxycyclohexyl phenyl ketone
- Cas Number:
- 947-19-3
- Molecular formula:
- C13H16O2
- IUPAC Name:
- 1-benzoylcyclohexan-1-ol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred and raised rabbits on the premises (Ciba-Geigy Ltd. - Exp. Toxicology Sisseln GU 2.1)
- Age at study initiation: Not reported
- Weight at study initiation: 2 to 3 kg
- Housing: Housed individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
- Time after start of exposure: Approximately 30 seconds after treatment in 3 of the 6 rabbits
SCORING SYSTEM: Same scale as the one provided in the OECD guideline, with the exception of 1 criteria (changes related to discharge were included in addition to the other parameters evaluated)
TOOL USED TO ASSESS SCORE: slit lamp
The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4, and 7 and was scored for each individual rabbit. The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4, and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed and rinsed eyes.
Index:
0 = none
0.1 - 10.9 = minimal
11.0 - 25.9 = slight
26.0 - 55.9 = moderate
56.0 - 84.0 = marked
above 84.0 = extreme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 80
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 4.7
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0.7
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0.7
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- other: 4 days
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test item was found to cause minimal irritation at cornea and conjunctiva (redness, chemosis, discharge) when applied to the rabbit eye mucosa (primary irritation index 3.8). When the application site was rinsed, irritation was minimized (primary irritation index 0.8) with effects at conjunctiva (redness, chemosis). Findings in cornea were observed in one animal and healed by the second day. Redness of the conjunctiva occurred in all animals with unrinsed eyes and a score 1 effect was still observed in one animal at the last observation time point.
Any other information on results incl. tables
Table 1. Calculation of the primary eye irritation index
Time after exposure (days) |
Mean Reaction Score |
|||||
Unrinsed eyes |
Rinsed eyes |
|||||
Cornea |
Iris |
Conjunctiva |
Cornea |
Iris |
Conjunctiva |
|
1 |
5 |
0 |
7.3 |
0 |
0 |
2 |
2 |
0 |
0 |
4.7 |
0 |
0 |
2 |
3 |
0 |
0 |
0.7 |
0 |
0 |
0 |
4 |
0 |
0 |
0.7 |
0 |
0 |
0 |
7 |
0 |
0 |
0.7 |
0 |
0 |
0 |
Subtotal |
5 |
0 |
14.1 |
0 |
0 |
4 |
Total |
19.1 |
4 |
||||
Primary irritation index in unrinsed eyes
19.1 / 5 = 3.8
Primary irritation index in rinsed eyes
4 / 5 = 0.8
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not irritant to the eyes when rinsed 30 seconds after application.
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