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EC number: 212-782-2 | CAS number: 868-77-9
- 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

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study, carried out by the Mitsubishi Chemical Safety Institute Ltd. (Japan). Guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-hydroxyethyl methacrylate
- EC Number:
- 212-782-2
- EC Name:
- 2-hydroxyethyl methacrylate
- Cas Number:
- 868-77-9
- Molecular formula:
- C6H10O3
- IUPAC Name:
- 2-hydroxyethyl methacrylate
- Details on test material:
- - Name of test material (as cited in study report): HEMA
- Analytical purity: 99.7%
- Storage condition of test material: cold, dark storage
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc.
- Age at study initiation: 7 weeks old
- Weight at study initiation: 259 to 282 g
- Housing: polycarbonate cages; 5 per cage
- Diet (e.g. ad libitum): pellets; ad libitum
- Water (e.g. ad libitum): flitered tap water; ad libitum
- Acclimation period: six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 to 23.2 deg C
- Humidity (%): 47.2 to 60 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 2000-11-28 To: 2000-12-03
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Dosing volume: 10 mL/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance was dissolved in water for injection. Then, this solution was diluted with the same solvent. Dosing solutions were administered to rats immediately after preparation.
- Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- Twice at 24 hour interval
- Post exposure period:
- Animals were sacrificed 24 hours after final administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000 and 2000 mg/kg
Basis:
- No. of animals per sex per dose:
- 5/group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: intraperitoneal
- Doses / concentrations: dissolved in water for injection at 1 mg/mL just before use.
Examinations
- Tissues and cell types examined:
- The femurs were dissected out and the bone marrow cells were collected.
The animals were weighted just before administration and before preparation of specimen. The animals were observed once or more per day of administration and preparation of specimen. - Details of tissue and slide preparation:
- The animals in each group were sacrificed 24-hours after the final administration.
Each rat was sacrificed by exsanguination from the abdominal aorta under anesthethesia with Ravonala (Tanabe Seiyaku Co.,Ltd. lot no. 07004) and the femurs were dissected out. The bone marrow cells were collected with PBS(-) (Nissui Pharmaceutical Co., Ltd.). The cells were centrifuged at 200 rpm for 5 min and were taken the supernatant. It wasresuspended in 10 % buffered formalin (Muto Pure Chemicals,Co., Ltd.) and was centrifuged at 1000 rpm for 5 min. After centrifugation, the cells were washed twice. Then, the cells were resusupended in a small amount of 10 % buffered formalin, and was stocked. The bone marrow suspension was stained with acridine orange, and was spread on a clean slide glass.
Slides were examined under blind condition and scored under a fluorescent microscope with B-2 excitation filter. One thousand erythrocytes were scored from each slide in order to determine the ratio of polychromatic erythrocytes (PCE's) to the total erythrocytes [PCE's and normochromatic erythrocytes (NCE's)]. PCEs were further scored up to 2000 cells, the number of micronucleated PCE's (MNPCE's) in a slide were examined (2 area, Total 2000 cells). PCE's and NCE's were identified according to the method of Hayashi et al 1. - Evaluation criteria:
- Only when a test substance induced a significant increase in the total number of dose-dependent MNPCEs, the test substance was considered positive in this assay.
- Statistics:
- For the analysis of the percentage of PCEs, Student's t-test were applied. For the incidence of MNPCEs, tables of Kastenbaum and Bowman were applied.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- There were no significant differences in the incidence of MNPCE's between any treatment group and the negative control group. There were significant increases in the incidences of PCE's between 1000 mg/kg group and the negative control group (p < 0.05). Clinical signs were not observed with all of test substance groups. The negative control incidences of MNPCE's among tests was within the range of our laboratory background data and positive control ones showed remarkable increase. These findings indicated that the test was conducted appropriately. This chemical does not induce micronuclei under the test conditions employed.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of this study, the test substance did not induce micronuclei. - Executive summary:
A bone marrow micronucleus study in seven week old, Sprague Dawley rats was conducted to assess the mutagenic potential of the test substance. The test substance was administered twice at 24 -hour interval by oral gavage at three doses of 500, 1000 and 2000 mg/kg. Twenty four hours after the final administration bone marrow samples were prepared, and were examined for incidence of micronucleated polychromatic erythrocytes. The test substance did not induce significant increases in the micronucleated polychromatic erythrocytes in any treated groups.
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