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Diss Factsheets
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EC number: 500-734-6 | CAS number: 162492-01-5
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Mar - 01 Apr 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in 2008
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM INVITTOX Protocol No 118: "EpiSkinTM Skin Corrosivity Test"
- Version / remarks:
- adopted in 2011
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
Test material
- Reference substance name:
- Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate
- EC Number:
- 500-734-6
- EC Name:
- Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate
- Cas Number:
- 162492-01-5
- Molecular formula:
- C39 H60 N6 O15
- IUPAC Name:
- Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: normal human epidermal keratinocytes (NHEK)
- Source strain:
- other: reconstructed three-dimensional human epidermis model (SkinEthic)
- Justification for test system used:
- This test uses the EPISKIN-SMTM reconstructed human epidermis model (SkinEthic) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. This method allows the identification of corrosive and non-corrosive substances and mixtures in accordance with UN GHS. It further allows a partial sub-caregorisation of corrosives in optional sub-category 1A or a combination of optional sub-categories 1B and 1C.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstituted three-dimensional human skin model EPISKIN-SMTM (SkinEthic) consisting of normal human epidermal keratinocytes
- Tissue batch number: 16-EKIN-013
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37 ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 mL, about 15 times
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h ± 15 min
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
For historical control data see table 1.
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin in accordance with Regulation EC 1272/2008 and UN GHS "Category 1" if the relative tissue viability after 4 h treatment is decreased below 35%: if viability is reduced to less than 35% after 4 h treatment and to more than 35% after 60 min treatment or to less than 35% viability after 60 min but not more than 35% after 3 min treatment, the test item is classified as corrosive, in accordance with optional UN GHS sub-categories 1B and 1C. A test item which decreases viability below 35% after 3 min treatment is classified as corrosive in accordance with optional UN GHS sub-category 1A.
- The test substance may be considered as non-corrosive to skin in accordance with UN GHS "No Category" if realtive tissue viability after 4 h treatment is not decreased to less than 35% of the corresponding negative control tissues. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 ± 2 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 0.9%
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 h, 60 min and 3 min
- Duration of post-treatment incubation (if applicable):
- Not applicable
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 59
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- other: no indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 102
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- other: no indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 4 h
- Value:
- 58
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 2% tissue viability
- Remarks on result:
- other: no indication of corrosion
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: A mixture of 20 mg test item per 2 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn purple/blue. Therefore, the non-specific reduction of MTT equaled 0%.
- Colour interference with MTT: A mixture of 10 mg of the test item per 90 µL aqua dest. and per 90 µL isopropanol showed no colouring as compared to the solvent. Therefore, non-specific colour of additional viable tissues equaled 0%.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The controls confirmed the validity of the study.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: See table 1 for historical control data.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/208
- Conclusions:
- CLP: not classified
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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