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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Jul 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted in 2013
- Deviations:
- no
- 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
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: abattoir A. Moksel AG, Buchloe, Germany
- Storage, temperature and transport conditions of ocular tissue: Fresh eyes were transported in Hanks´balanced salt solution containing penicillin/streptomycin on ice. Immediately after arrival of the eyes at the laboratory, cornea preparation was initiated.
- Indication of any existing defects or lesions in ocular tissue samples: no (visual examination)
- Indication of any antibiotics used: no
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 10 min at 32 ± 1°C
- Observation period (in vivo):
- Not applicable
- Duration of post- treatment incubation (in vitro):
- 2 h at 32 ± 1°C
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The eyes were carefully visually examined for defects and any defective eyes were discarded. The tissue surrounding the eyeball was carefully pulled way and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS and mounted in corneal holders with the endothelial side against the O-ring of the posterior chamber. The anterior chamber was then positioned on top of the cornea and tightened with screws. The chambers were filled with RPMI medium (without phenol red) containing 1% fetal bovine serum and 2 mM L-glutamine (complete RPMI). The corneas were equilibrated for 1 h at at 32 ± 1°C. After the equilibration period, the medium was replaced with fresh complete RPMI.
QUALITY CHECK OF THE ISOLATED CORNEAS
An initial measurement was performed on each of the corneas using the opacitometer.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
0.9% NaCl (physiological saline)
POSITIVE CONTROL USED
100% ethanol
APPLICATION DOSE AND EXPOSURE TIME
750 µL of the test substances and control substances for 10 min at 32 ± 1°C
TREATMENT METHOD: open chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times
- POST-EXPOSURE INCUBATION: 2 h at 32 ± 1°C
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: illuminance measurement using a calibrated opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: decision criteria as indicated in the TG was used
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- -0.06
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline: IVIS of the positive control (100% ethanol; 32 replicates): 46.61 (mean value, MV); 9.15 (standard deviation, SD); 28.3 (MV - 2 x SD); 64.92 (MV + 2 x SD)
In vivo
- Irritant / corrosive response data:
- With the negative control (0.9% (w/v) NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (2-ethoxyethanol) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as serious eye damaging. Relative to the negative control, the test item did not cause an increase of the corneal opacity or permeability. The calculated mean in vitro irritancy score (IVIS) was -0.06.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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