Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 603-188-8 | CAS number: 127184-53-6
- 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, caprolactam-blocked (IPDI homopolymer, caprolactam blocked) is not irritating to skin (Hüls AG, 1986).
The test substance is slightly irritating to eyes (Hüls AG, 1986), which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".
With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity').
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:
- 1986-03-07 to 1986-03-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.0 - 2.3 kg
Environmental conditions:
- Room temperature: 20°C (+/- 1°C)
- Hhumidity: 60% (+/- 5%)
- Air change: 15 times/hour
- Light: 12 hour light/dark rhythm
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany)
- Water: tap water ad libitum
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g test item was wetted with 0.5 ml water
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Post exposure period: 6 days
- Number of animals:
- 3 males
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm2
- Total quantity applied: 0.5 g wetted with 0.5 ml water
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: The test material had turned solid and stuck to the skin together with the patch, thus some force had to be exerted carefully. After rinsing with water, some small particles remained on the skin.
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours and 6 days after patch removal; evaluation based on readings 1-4
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 min, 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: none of the three rabbits showed any test item related changes; test substance: IPDI homopolymer, caprolactam-blocked, approx. 100%
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 min, 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60 min, 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0 - Other effects:
- no other effects
- Conclusions:
- Under the present test conditions, none of the three male rabbits exposed for 4 hours to 500 mg cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopolymer, caprolactam-blocked) per patch and animal (occlusive condition) showed any test item-related changes at the examination time-points 60 minutes, 24, 48 and 72 hours after patch removal. Therfore, cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked is not irritating to skin.
- Executive summary:
The acute skin irritation properties of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopolymer, caprolactam-blocked) 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 occlusive conditions. The test substance was administered undiluted, wetted with water. 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: erythema/eschar: 0, edema: 0. Therefore, cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked is not irritating to skin.
Reference
no further results
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:
- 1986-03-07 to 1986-03-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: female
- Weight at study initiation: 2.4 - 2.6 kg
- Controls: untreated eye
Environmental conditions:
- Room temperature: 20°C (+/- 1°C)
- Hhumidity: 60% (+/- 5%)
- Air change: 15 times/hour
- Light: 12 hour light/dark rhythm
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany)
- Water: tap water ad libitum
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 g - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- Postexposure observation period: 6 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Vehicle: none
- rinsed after 72 h
- Postexposure observation period: 6 days
EXAMINATIONS
- Ophtalmoscopic examination: 60 min, 24, 48, 72 hours, and 6 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 8
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.67
- 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: 0.56
- Iris: 0.33
- Conjunctivae (Redness): 0.67
- Conjunctivae (Chemosis): 0.11
- Overall irritation score: 8
REVERSIBILITY: complete within 72 hours - Other effects:
- no other effects
- Conclusions:
- Under the conditions of this study cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopoymer, caprolactam blocked) showed slightly eye irritating effects in rabbits, which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritant to eyes".
- Executive summary:
A study was performed to examine eye irritating effects of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopoymer, caprolactam blocked) according to OECD TG 405. An amount of 0.1 g of the undiluted test substance was instilled into the conjunctival sac of the right eye of each of three female rabbits, and the untreated left eye served as control. The fluorescein test was performed 72 hours after instillation and thereafter the treated eyes were rinsed with warm NaCl solution. The eye reactions were monitored until the changes observed have completely subsided, however not for more than 21 days after application. Eye irritation index was assessed using Draize scale.
The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 0.56, iris: 0.33, conjunctivae: redness: 0.67 and chemosis: 0.11 (mean scores on Draize scale). All irritating effects were fully reversible within 72 hours. Therefore, under the conditions of this study Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked showed slightly eye irritating effects in rabbits, which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".
Reference
no other results
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked (IPDI homopoymer, caprolactam blocked) is not irritating to skin of rabbits (OECD 404; Hüls AG, 1986).
The test substance showed slightly eye irritating effects in rabbits (OECD 405, Hüls AG, 1986), which do not meet citeria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".
With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1 (see chapter 'Repeated Dose Toxicity').
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, caprolactam-blocked (IPDI homopoymer, caprolactam blocked) is not irritating to skin and eyes.
With regard to local effects in the respiratory tract the substance is classified for repeated toxicity with STOT RE 1.
Thus, according to EU Regulation 1272/2008 no classification for respiratory tract irritation is warranted.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
