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Diss Factsheets
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EC number: 946-383-6 | CAS number: -
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to a recognised guideline in accordance with generally accepted scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA Procedure - Draize Scoring method (Federal Register, Vol. 38, No. 187, Sept. 27, 1973, §1500.41)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction mass of 2-Ethylhexyl N-(5-isocyanato-2-methylphenyl)carbamate and 2-Ethylhexyl N-(3-isocyanato-4-methylphenyl)carbamate and N,N'-(4-Methyl-1,3-phenylene)bis(carbamic acid) C,C'-bis(2-ethylhexyl) ester
- EC Number:
- 937-955-6
- Molecular formula:
- components with the molecular formulae C25H42N2O4 and C17H24N2O3
- IUPAC Name:
- Reaction mass of 2-Ethylhexyl N-(5-isocyanato-2-methylphenyl)carbamate and 2-Ethylhexyl N-(3-isocyanato-4-methylphenyl)carbamate and N,N'-(4-Methyl-1,3-phenylene)bis(carbamic acid) C,C'-bis(2-ethylhexyl) ester
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Diet (e.g. ad libitum): Appropriate Wayne diet ad libitum.
- Water (e.g. ad libitum): ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: both intact and abraded sited clipped free of hair.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- No further detail on the study design is given, but the guideline is quoted: Federal Register, Vol. 38, No. 187, Sept. 27, 1973, §1500.41: Method of testing primary irritant substances
Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects are used in abraded and intact skin tests. Introduce under a square patch, such as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 millilitre (in the case the of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in a appropriate solvent and apply the solution as for liquids.
The animals are immobilised with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberised cloth for the 24 hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances.
After 24 hours of exposure, the patches are removed and the resulting reactions evaluated on the basis of the designated values in the following table.
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptable) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4
Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours. Add values for erythema and eschar formation at 24 and 72 hours for intact skin to the value son abraded skin at 24 and 72 hours.
Similarly, add the values for oedema formation at 24 and 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: Overall score
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Irritation parameter:
- erythema score
- Basis:
- animal: mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Not specified
- Irritation parameter:
- edema score
- Basis:
- animal: mean
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks on result:
- other: Not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Primary Irritation Score equal to 1.2.
- Executive summary:
The skin irritation potential of the test material was assessed in New Zealand White rabbits according to the FHSA Procedure - Draize Scoring method (Federal Register, Vol. 38, No. 187, Sept. 27, 1973, §1500.41)
The material was applied to the clipped intact and abraded skin of 6 animals and occluded for 24 hours. Skin reactions were observed and evaluated after 24 and 72 hours, resulting in a primary irritation score equal to 1.2.
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