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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23. Jan 1979 to 26. Jan 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Similar to guideline OECD 404 with acceptable restrictions, limited documentation
Qualifier:
according to guideline
Guideline:
other: EPA guideline (not further specified)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Observation period only up to 48 h after end of exposure
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bunnyville Farm, Littlestown, USA
- Housing: individually
- Diet (ad libitum): Purina rabbit chow
- Water (ad libitum): automated water supply
Type of coverage:
other: covering by polyethylene tubing and elastic bandage
Preparation of test site:
other: 4 shaved application sites per animal, two of it abraded
Vehicle:
other: application sites were premoistened with physiological saline before application of the test substance
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per application site
Duration of treatment / exposure:
24 h
Observation period:
up to 72 h after application (48 h after end of exposure)
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: one square inch
- % coverage: 100
- Type of wrap if used: gauze patch held in place with transparent tape, fixed by a nonabsorbent binder composed of polyethylene tubing and elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance was wiped off (no further details)

SCORING SYSTEM: according to Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 h after application (0 or 48 h after end of exposure)
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 h after application (0 or 48 h after end of exposure)
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
No irritating effects were observed neither for intact nor abraded skin
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test substance was not irritating
Executive summary:

Six New Zealand white rabbits were exposed dermally to the test substance according to EPA guidelines (similar to guideline OECD 404). 0.5 g of test item were applied to four shaved application sites per animal, two of which were abraded. After 24 h of exposure the substance was wiped off and the effects evaluated at 24 and 72 h after application. No erythema or edema were observed at any time point, neither on intact nor on abraded skin. Under the conditions of this study, the test substance was not irritating to the skin of rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
other: EPA requirements for hazard evaluation (not further specified)
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
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

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
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
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
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
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.

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)

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Dermal irritation

Rabbits were exposed dermally to Cyclohexanone oxime (CHO) according to EPA guidelines (similar to guideline OECD 404). No erythema or edema were observed at any time point, neither on intact nor on abraded skin. Under the conditions of this study, CHO was not irritating to the skin of rabbits.

Eye irritation

Rabbits were tested in an eye irritation study according to EPA requirements of hazard evaluation (Draize test, similar to OECD guideline 405). The following mean scores (6 animals, 24, 48 and 72 h) were reported: Cornea score:1, iris score: 0.61, conjunctivae redness score: 2.16 and chemosis score: 0.95. All signs of irritation fully recovered within 24 h to10 days (depending on endpoint and individual variability).

Therefore under the conditions of this study, CHO was irritating, but not corrosive to the eyes of rabbits.

Respiratory irritation

No information is available.


Justification for selection of skin irritation / corrosion endpoint:
Only reliable study available

Justification for selection of eye irritation endpoint:
Only reliable study available

Effects on eye irritation: irritating

Justification for classification or non-classification

CHO has not to be classified for skin irritation according to Regulation (EC) No 1272/2008, based on a reliable study.

Based on a reliable study, CHO was irritating to the eyes of rabbits. As all effects were fully reversible within at most 10 days, it was not corrosive. Therefore, a classification as eye irritant is necessary: Eye Irrit. 2, H319, according to Regulation (EC) No 1272/2008)

 

No information is available on respiratory irritation, but inhalation is not expected to be an exposure route of concern.