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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: 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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- 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.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Three-dimensional human epidermis model - EpiDerm
- Cell source:
- other: No data
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: Human
- Sex: No data
- Age at study initiation (in days): No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data - Justification for test system used:
- EpiDerm is recommended per OECD 431 guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm
- Tissue batch number(s): 27170 Kit C
- Production date: No data
- Shipping date: No data
- Delivery date: 24 Oct 2017
- Date of initiation of testing: 25 Oct 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 2 washing steps, volume not reported.
- Observable damage in the tissue due to washing: None
- Modifications to validated SOP: None
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 uL at 1 mg/mL MTT
- Incubation time: 3 hours
- Spectrophotometer: uQuant Plate Reader, Bio-Tek Instruments
- Wavelength: 540 nm
- Filter: No data
- Filter bandwidth: No data
- Linear OD range of spectrophotometer: No data
NUMBER OF REPLICATE TISSUES: 3 per group (test, negative control, positive control).
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE : No data
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 experiment in triplicate.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 uL
- Concentration (if solution): Neat
VEHICLE : None
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 uL
- Concentration (if solution): NA
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 uL
- Concentration (if solution): 8.0 N - Duration of treatment / exposure:
- 3 and 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hour incubation with MTT post-exposure
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 Minute Exposure Mean
- Value:
- 80.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 Minute Exposure Mean
- Value:
- 4.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: None
- Colour interference with MTT: None
DEMONSTRATION OF TECHNICAL PROFICIENCY: The laboratory has demonstrated proficiency in running OECD 431 with EpiDerm tissues.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the mean OD of the negative control tissues was 2.246 at 3 minutes and 2.092 at 60 minutes, which met the acceptance criterion (OD greater than or equal to 0.8).
- Acceptance criteria met for positive control: Yes, the mean relative tissue viability of the 60-minute positive control was 2.4%, which met the acceptance criterion (>15%).
- Acceptance criteria met for variability between replicate measurements: Yes, viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 2.9% to 7.7%. Viability differences between the two identically treated tissues at 60 minutes were 0.1 % to 1.3%. Inter-tissue viability differences at both time points met the acceptance criterion (>30%)
- Range of historical values if different from the ones specified in the test guideline: Per OECD 431.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Based on the results of the study (3 minute viability 4.7%, 60 minute viability 80.6%), MDP is corrosive when tested according to OECD 431 with EpiDerm tissues.
- Executive summary:
The skin corrosion potential of MDP was evaluated in MatTek EpiDerm tissues. The study was conducted according to OECD 431 in compliance with OECD GLP. EpiDerm tissues were exposed (N=3) to 50 uL of the test article (MDP), negative control (tissue culture water), and positive control (potassium hydroxide, 8.0 N) for 3 and 60 minutes. Following exposure the tissues were washed and incubated with MTT to determine tissue viability. Relative viability was 80.6% after a 3 minute exposure and 4.7% after a 60 minute exposure. Based on the results of the study (3 minute viability 4.7%, 60 minute viability 80.6%), MDP is corrosive when tested according to OECD 431 with EpiDerm tissues.
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