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EC number: 202-874-0 | CAS number: 100-64-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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. - 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.
Reference
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)
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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