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EC number: 606-423-2 | CAS number: 200295-52-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 3,5-dimethyl-1H-pyrazole
- EC Number:
- 606-423-2
- Cas Number:
- 200295-52-9
- Molecular formula:
- >= C51H78N12O6 (IPDI-Isocyanurate n=3, blocked with 3,5-dimethylpyrazole)
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 3,5-dimethyl-1H-pyrazole
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Albino rabbits Crl: KBL(NZW)BR
- Sex: female
- Source: Charles River, 88353 Kisslegg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 2.6 - 2.7 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: unchanged (no vehicle), but moistened with corn oil to ensure good contact with the skin
- Controls:
- other: the contralateral skin area of the same animal, treated with 0.5 mL corn oil, was used as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals were monitored until changes had completely subsided, however, for not more than 14 days after application.
- Number of animals:
- 3
- Details on study design:
- On the day before the test, the fur was shorn on the right and left side from the dorso-Iateral area of the trunk of each of the rabbits. Care was taken to avoid abrading the skin. Only animals with healthy and intact skin were used.
0.5 g of the pulverized test substance moistened with com oil (to ensure good contact with the skin) was applied to the skin of the animal under a gauze patch. 0.5 mL com oil was applied as control on the contra lateral skin area for the 4 hour treatment period. The treated skin area was approximately 2.5 cm by 2.5 cm in size. The patch was placed on the dorso-Iateral areas of the trunk of each animal and was held in place with non-irritating tape for the duration of the exposure period.
Due to a possible irritant potential of the test substance, in the first step only one animal was used and three test patches were applied successively to this animal, as described above. The first patch was removed after three minutes. As no serious skin reactions were observed, the second patch was applied and removed after one hour. At this stage the observations indicated that with respect to animal welfare the exposure can be allowed to extend to four hours, therefore the third patch was applied and removed after four hours and the responses were graded one hour later. The test was completed using two additional animals, exposed for four hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 4 hours the exposed skin area was carefully washed with water.
- Time after start of exposure: After the exposure period (4 hours) the dressing and patch were removed.
OBSERVATION TIME POINTS
- 1, 24, 48 and 72 hours after patch removal. If no irritation indices were observed after 72 h, the study was finished. If dermal irritation was observed, animals were monitored usually on day 7 and 14 after patch removal until the changes had completely subsided, however for not more than 14 days after application.
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (redness and eschar formation)
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There were no relevant systemic intolerance reactions.
Applicant's summary and conclusion
- Executive summary:
An acute skin irritation/corrosion test according to OECD TG 404 was conducted on 3 rabbits receiving each 0.5 g of the unchanged test substance on the previously shorn but healthy and intact skin. Corn oil was used to moisten the test substance in order to ensure a good contact with the skin. Due to a possible irritant potential of the test substance a stepwise approach was chosen. In the first step only one animal was used and three test patches were applied to this animal. After three minutes the first patch was removed and if no skin reactions were observed, the second patch was applied and removed after one hour. If at this stage the observations indicated that with respect to animal welfare the exposure can be extended to four hours, the third patch was applied and removed after four hours and the responses were graded one hour later. The test was then completed using two additional animals, each exposed for four hours. Skin irritation was scored and recorded approx. at 1, 24, 48 and 72 hours after patch removal. If no irritation indices were observed after 72 h, the study was finished. If dermal irritation was observed, animals were monitored usually on day 7 and 14 after patch removal until the changes had completely subsided, however for not more than 14 days after application.
As result a single application of 0.5 g test substance to the skin did not cause any changes (erythema and edema scores all zero after 24, 48, and 72 hours). No relevant systemic intolerance reactions were noted.
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