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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
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- Oxidation reduction potential
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- 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
Endpoint summary
Administrative data
Description of key information
Two in vitro/ex vivo studies were conducted with MDP to determine its skin and eye irritation/corrosion potential. The results of the studies were:
When tested according to OECD 431: Corrosive (GHS Category 1) to the skin.
When tested according to OECD 437: Corrosive (GHS Category 1) to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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)
- 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 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
- 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. - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- 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
- 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)
- 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. - 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. - 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 - 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. - 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).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for classification or non-classification
Based on the results of the studies, MDP meets the GHS Classification Criteria for Category 1 (Corrosive) for both eye and skin.
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