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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Remarks:
- No deviations ocurred that impacted the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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, Lot FiS 18/013
- Purity, including information on contaminants, isomers, etc.: Reaction mass ass described in the general information section.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING : None, dosed neat.
- Treatment of test material prior to testing (e.g. warming, grinding):
FORM AS APPLIED IN THE TEST :The test article was dosed neat.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Inc.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 12 weeks
- Weight at study initiation: 226-237 g
- Fasting period before study: 16-20 hours prior to dosing
- Housing: Animals were individually and group housed in stainless steel or plastic suspended cages identified by a card indicating the lab number, animal numbers, test code, sex and date dosed.
- Diet (e.g. ad libitum): A commercially available rodent feed, PROLAB RMH 1000 - 5P07, was provided daily.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: 30 days
- Microbiological status when known : No data
- Method of randomisation in assigning animals to test and control groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 8 May, 2015 To: 22 May, 2015
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: NA, dosed neat.
MAXIMUM DOSE VOLUME APPLIED: No data
DOSAGE PREPARATION (if unusual): The test article was dosed neat.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:The test article was not expected to be acutely lethal so a starting dose of 2,000 mg/kg was selected. - Doses:
- 2,000 mg/kg.
- No. of animals per sex per dose:
- 5 females were dosed.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded at dosing and at 14 days for survivors.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: Animals were observed immediately after dosing, at 4 hours, and daily for up to 14 days for signs of illness or mortality. Body weights were recorded at dosing and at 14 days for survivors.
- Other examinations performed: clinical signs, body weight,gross necropsy. - Statistics:
- Mean body weights for all animals will be calculated at dosing and for survivors at day 14. Statistical manipulation of data is not applicable to this study.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the 14 day study.
- Clinical signs:
- other: No clinical signs were observed that were related to test article administration.
- Gross pathology:
- No macroscopic findings were noted upon necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, the acute oral LD50 of MDP is greater than 2,000 mg/kg body weight.
- Executive summary:
The acute oral toxicity of MDP was evaluated in female Wistar rats. This study was performed in accordance with US FDA GLP. The study design was based on OECD 423 (2001) and ISO 10993-11: 2006. Five female rats received 2,000 mg/kg MDP via oral gavage at approximately 2 mL/kg (density = 1.002 g/mL). The rats were observed through 14 days post-dose. Body weights were recorded pretest and at termination. All animals were examined for gross pathology. All animals survived. There were no abnormal clinical observations, body weight changes or necropsy findings in any animals. Based on the results of the study, the acute oral LD50 of MDP is greater than 2,000 mg/kg body weight.
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