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Diss Factsheets
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EC number: - | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- No data
- Deviations:
- no
- Remarks:
- No deviations ocurred that negatively impacted the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate
- Molecular formula:
- C18H30O4 and C14H27O6P
- IUPAC Name:
- Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
3M Company,
- Purity, including information on contaminants, isomers, etc.:
Reaction product as described in the general information section.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage:
NA
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis:
No data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium:
No data
- Reactivity of the test material with the incubation material used (e.g. plastic ware):
No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
: None, dosed neat.
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Spear Products
- Number of animals: No data
- Characteristics of donor animals (e.g. age, sex, weight): No data
- Storage, temperature and transport conditions of ocular tissue: Eyes were transported under refrigeration.
- Time interval prior to initiating testing: The eyes were dosed the same day as they arrived.
- Indication of any existing defects or lesions in ocular tissue samples: Only eyes free of defects were used.
- Indication of any antibiotics used: Penicillin-streptomycin was used.
- Selection and preparation of corneas: The eyes were examined prior to use on the day of dosing. Any eye with a cornea exhibiting evidence of vascularization, pigmentation, opacity or scratches was discarded. Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The corneas were then placed in a container of fresh HBSS.
- Quality check of the isolated corneas: The dissected corneas were mounted in specially designed holders that were separated into anterior and posterior chambers and filled separately. Each cornea was mounted allowing the epithelium of the cornea to project into the anterior chamber. The posterior chamber was filled with MEM solution ensuring contact with the endothelium. The anterior chamber was filled with MEM solution, ensuring contact with the epithelium. Each cornea was visually inspected again to ensure there were no defects. The entire holder was incubated at 32 (±1)°C and allowed to equilibrate for at least one hour, but not longer than two hours. A pre-exposure determination of opacity was made for each cornea by measuring each against the blank supplied by the opacitometer. Any cornea with a value greater than 7 units was discarded.
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): 0.75 mL
- Concentration (if solution): neat
VEHICLE: None - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3 ex vivo replicates
- Details on study design:
- NUMBER OF REPLICATES
: 3
NEGATIVE CONTROL USED : Minimal Essential Media
SOLVENT CONTROL USED: NA
POSITIVE CONTROL USED : 100% Ethanol
APPLICATION DOSE AND EXPOSURE TIME : 0.75 mL for 10 minutes
TREATMENT METHOD: Closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least 2
- POST-EXPOSURE INCUBATION: 2 hours
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: A
measurement of opacity was taken with each treated cornea compared to the blank supplied with the OP-KIT. This reading was used in the final IVIS calculations.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Per OECD 437
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 82.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Run / experiment:
- Mean (OD 490 nm)
- Value:
- 0.264
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Corrected Mean Optical Density
- Remarks:
- Corrected Mean Optical Density
- Run / experiment:
- Mean
- Value:
- 0.241
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- 86.28
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- IVIS = 0.35
- Positive controls validity:
- valid
- Remarks:
- IVIS = 25.83
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None
DEMONSTRATION OF TECHNICAL PROFICIENCY: The lab is proficient in running OECD 437.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: No data
- Acceptance criteria met for positive control: The ethanol positive control IVIS was 25.83, which fell within the acceptance range of 16.96 - 37.00
(± 2 standard deviations of the historical mean).
- Range of historical values if different from the ones specified in the test guideline: Per OECD 437.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results of the study (IVIS = 86.28), MDP is corrosive (GHS Category 1) in the Bovine Corneal Opacity and Permeability Test (BCOP).
- Executive summary:
The eye irritancy/corrosion potential of MDP was evaluated in the Bovine Corneal Opacity and Permeability Test (BCOP). The study was conducted according to OECD 437 in compliance with OECD GLP. Corneas (N=3) were exposed to 0.75 mL of the test article (MDP), negative control (MEM), or positive control (100% Ethanol) for 10 minutes. Corneal opacity was determined at 10 minutes and 2 hours post-exposure. Corneal permeability was determined following a 90 minute incubation with fluorescein on the anterior side of each cornea. The amount of dye that passed through the cornea was measured by spectrophotometer at 490 nm. Exposure to MDP resulted in a mean corneal opacity score of 82.7, mean corneal permeability of 0.264 and mean corrected optical density of 0.241, resulting in an In Vitro Irritancy Score (IVIS) of 86.28. Based on the results of the study (IVIS = 86.28), MDP is corrosive (GHS Category 1) in the Bovine Corneal Opacity and Permeability Test (BCOP).
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