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EC number: 600-028-9 | CAS number: 1001254-87-0
- 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
Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked is not irritating to skin (NOTOX B.V., 2001). The test substance is slightly irritating to eyes (NOTOX B.V., 2001), which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".
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:
- 2001-05-22 - 2001-05-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.4
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River Deutschland (Germany)
- Sex: male
- Age: at least 6 weeks old
- Controls: untreated skin surrounding the application area
- Diet: ad libitum, Altromin special diet for rabbits
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g test substance, moistened with 0.8 ml vehicle
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
- Number of animals:
- 3 males
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance, approx. 10 x 15 cm2
- Vehicle: water
- Preparation of test substance: fine grinding in mortar, 500 mg test substance was moistened with 0.8 ml water to ensure close contact with skin
- Occlusion: metalline patch (2x3 cm) held in place by semi-occlusive non-irritating tape dressing
- Duration: 4 h , after application was removed, skin was cleaned with water
EXAMINATIONS
- Examination time points: 60 minutes, 24, 48, and 72 hours after patch removal
- Scoring system: Draize (0-4 possible scores each for erythema/eschar and for edema) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 min, 24 hrs, 48 hrs, 72 hrs
- Score:
- 0.17
- Max. score:
- 8
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0.22
- Edema: 0
REVERSIBILITY: fully reversible within 72 h - Other effects:
- Under the test conditions one of the three rabbits showed very slight erythema between 24 and 48 hours.
- Conclusions:
- Under the test conditions one of the three rabbits showed very slight erythema between 24 and 48 hours. Therefore, the test item is not irritating to skin.
- Executive summary:
The acute skin irritation properties of the test item were estimated according to OECD Guideline 404.
A dose of 500 mg test item per animal was applied to the shaved, intact dorsal skin of 3 male rabbits under semi-occlusive conditions. After the 4 -hour exposure period the patch was removed and the resulting reactions were examined.
The average scores at 60 min, 24, 48 and 72 hours after patch removal are as follows: one of the three rabbits showed very slight erythema between 24 and 48 hours.
Therefore, the test item is not irritating to skin.
Reference
no other information
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:
- 2001-05-28 - 2001-05-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: Charles River Deutschland (Germany)
- Sex: male
- Age: at least 6 weeks old
- Controls: untreated eye
- Diet: ad libitum, Altromin special diet for rabbits
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animal, left eye
- Amount / concentration applied:
- undiluted, test substance was grounded to a powder using a mortar
Amount applied: 0.82 mg, a volume of approximately 0.1 ml/animal - Duration of treatment / exposure:
- not rinsed; no removal of test substance
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- - not rinsed
- Ophthalmoscopic examination with a slit lamp: prior to the administration and 1, 24, 48 and 72 hours after administration; 24 hours after
administration, the eyes were treated additionally with fluorescein and examined.
- Scoring system: Draize - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0
- Conjunctivae (Redness): 0.78
- Conjunctivae (Chemosis): 0.11 - Other effects:
- There were no systemic intolerance reactions.
- Conclusions:
- Under the conditions of this study the test item showed only slightly eye irritating effects in rabbits.
- Executive summary:
A study was performed to examine eye irritating effects of test item according to OECD TG 405.
An amount of 0.82 mg was instilled into the conjunctival sac of the right eye of each of three male rabbits, and the untreated left eye served as control.
Observations were made 1, 24, 48 and 72 hours after instillation.
Under the present test conditions, test item caused the following effects: The iris and conjunctivae was not effected after instillation of the test substance. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 72 hours. There were no systemic intolerance reactions.
Therefore, under the conditions of this study test item showed only slightly eye irritating effects in rabbits.
Reference
no further remarks
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked is not irritating to skin of rabbits (OECD 404; NOTOX B.V., 2001, 2001). The test substance is slightly irritating to eyes in rabbits (OECD 405; NOTOX B.V., 2001), which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".
Justification for selection of skin irritation / corrosion endpoint:
Only one study available.
Justification for selection of eye irritation endpoint:
Only one study available.
Justification for classification or non-classification
Based on the assessment of two animal studies (skin and eye irritating) and according to criteria of EC Regulation 1272/2008 cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked is not irritating to skin and eyes. Therefore, the test substance must not be classified.
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