Cyclohexanone oxime

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29. Jan 1979 to 8 Feb. 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to guideline OECD 405 with acceptable restrictions, limited documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EPA requirements for hazard evaluation (not further specified)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Observation period only 10 days

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexanone oxime

EC Number:

202-874-0

EC Name:

Cyclohexanone oxime

Cas Number:

100-64-1

Molecular formula:

C6H11NO

IUPAC Name:

cyclohexanone oxime

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): cyclohexanone oxime
- Substance type: white crystalline powder
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Bunnyville Farm, Littlestown, USA
- Housing: individually
- Diet (ad libitum): Purina rabbit chow
- Water (ad libitum): automated water supply

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as internal control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

Eyes of 6 animals remained unrinsed, eyes of 3 animals were washed 30 sec after instillation for 1 minute with lukewarm tap water

Observation period (in vivo):

up to 10 days post instillation

Number of animals or in vitro replicates:

9

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 6 animals unwashed, 3 washed (see "duration of treatment")
- Time after start of exposure:

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4-7 days

Remarks on result:

other: unwashed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0.61

Max. score:

2

Reversibility:

fully reversible within: 24h - 4 days

Remarks on result:

other: unwashed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

2.16

Max. score:

3

Reversibility:

fully reversible within: 7-10 days

Remarks on result:

other: unwashed

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0.95

Max. score:

4

Reversibility:

fully reversible within: 72 h - 7 days

Remarks on result:

other: unwashed

Irritant / corrosive response data:

Corneal opacity, involving from less than 25% to 100% of the cornea, was noted in four unwashed eyes through Day 4, in two unwashed eyes through seventy-two hours, in one washed eye at twenty-four hours only, and in one washed eye through forty-eight hours. Iritis was noted in one unwashed eye at twenty-four hours only, in one unwashed eye at twenty-four and seventy-two hours, in one unwashed eye at forty-eight and seventy-two hours, and in two unwashed eyes through seventy-two hours. Slight conjunctival redness to diffuse beefy redness was noted in five unwashed eyes through Day 7, one unwashed eye through Day 4, in one washed eye through seventy-two hours, and at twenty-four and seventy-two hours in two unwashed eyes. Slight to moderate chemosis, with
paraial eversion of the eyelids, was noted in two unwashed eyes through forty-eight hours, in two unwashed eyes through seventy-two hours, in two unwashed eyes through Day 4, and at twenty-four hours only in one washed eye. Slight to moderate discharge was observed in four unwashed eyes through forty-eight hours, through seventy-two hours in the two remaining unwashed eyes, and at twenty-four hours only in one washed eye.

Any other information on results incl. tables

Individual scores (mean of 24, 48 and 72 h) for animals with unwashed eyes:

Cornea: 1 for all 6 test animals

Iris: 2 x 1, 2 x 0.67, 1 x 0.33, 1 x 0.0

Conjunctivae redness: 1 x 3, 1 x 2.67, 1 x 2.33, 2 x 2, 1 x 1

Chemosis: 1 x 1.33, 3 x 1, 2 x 0.67

The scores for washed eyes were markedly lower (data not reported here)

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test substance was irritating to the eyes of rabbits. The observation period was 10 days (shorter than 21 days as as demanded in guideline OECD 405), but as all effects were fully reversible within 10 days, this is sufficiently long to exclude corrosive properties (irreversible effects) of the test substance.

Executive summary:

Six New Zealand white rabbits were tested in an eye irritation study according to EPA requirements of hazard evaluation (Draize test, similar to OECD guideline 405). 0.1 g of the test substance were applied to the left eye of each animal, the other eye served as internal control. The irritating properties were examined 24, 48 and 72 h as well as on days 4, 7 and 10 after application. The following mean scores (6 animals, 24, 48 and 72 h) were reported: Cornea score of 1, iris score of 0.61, conjunctivae redness score of 2.16 and chemosis score of 0.95. Within 24 h to10 days (depending on endpoint and individual variability) all signs of irritation had fully recovered.

Therefore under the conditions of this study, the test substance was irritating, but not corrosive to the eyes of rabbits. This is based on a mean cornea score >/= 1 and a conjunctivae score >/= 2 (according to classification in CLP-Regulation (EC) No. 1272/2008).

Additional 3 animals were tested after rinsing the eyes 30 sec after application. The irritation scores were markedly lower.