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EC number: 676-712-6 | CAS number: 68890-85-7
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 02, 1998 to January 16, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-066-5
- EC Name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- Cas Number:
- 28961-43-5
- Molecular formula:
- n.a.
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[(1-oxo-2- propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
- Reference substance name:
- 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate
- EC Number:
- 239-701-3
- EC Name:
- 2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate
- Cas Number:
- 15625-89-5
- Molecular formula:
- C15H20O6
- IUPAC Name:
- 2,2-bis(prop-2-enoyloxymethyl)butyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Identification: PURIFIED TMPEOTA
Test Substance: Code PRO-2687
Chemical name (IUPAC): ETHOXYLATED TRIMETHYLOL PROPANE TRIACRYLATE
Description: Clear slightly yellow liquid
Batch: CLX 598/1
Purity: treated as 100% pure
Test substance storage: In refrigerator in the dark
Stability under storage conditions: Stable
Expiry date: 12 May 1999
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 5-7 weeks old
- Weight at study initiation: 27.2-34.8
- Housing: housed in labelled polycarbonate cages containing purified sawdust
- Diet (e.g. ad libitum): standard pelleted laboratory animal diet; ad libitum
- Water (e.g. ad libitum):tap-water; ad libitum
Environmental conditions
- Temperature: 21 ± 3°C
- Humidity: 30-70%.
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Concentration of test substance in vehicle: 250mg/10mL, 125mg/10mL and 62.5mg/10mL - Details on exposure:
- The mice received a single intraperitoneal injection of a maximum tolerated (high), of an intermediate and of a low dose of the test substance. The route of administration was chosen to maximize the chance of the test substance to reach the target tissue. The dosing volume was 10 mL/kg bw.
- Duration of treatment / exposure:
- Single dose
- Frequency of treatment:
- Once
- Post exposure period:
- - 24h and 48h: treatment groups
- 48h: positive conrol
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- nominal concentration
- Dose / conc.:
- 62.5 mg/kg bw/day (actual dose received)
- Remarks:
- nominal concentrations
- Dose / conc.:
- 125 mg/kg bw/day (actual dose received)
- Remarks:
- nominal concentrations
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Remarks:
- nominal concentrations
- No. of animals per sex per dose:
- 5 (two groups per dosage)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - positive control: cyclophosphamide (CPA)
- Route of administration: intraperitoneal
- Doses / concentrations: 50mg/kg bw
Examinations
- Tissues and cell types examined:
- - Bone marrow
- The number of micronucleated polychromatic erythrocytes was counted in 2000 polychromatic erythrocytes. - Details of tissue and slide preparation:
- The slides were automatically stained using the "Wright-stain-procedure" in an "Ames" HEMA-tek slide stainer (Miles, Bayer Nederland B.V.). The dry slides were dipped in xylene before they were embedded in MicroMount and mounted with a coverslip.
- Evaluation criteria:
- - A test substance is considered positive in the micronucleus test if:
It Induced a biologically as well as a statistically significant (Wilcoxon Rank Sum Test; two-sided test at P < 0.05) increase in the frequency of micronucleated polychromatic erythrocytes (at any dose or at any sampling time) in the combined data for both sexes or in the data for male or female groups separately.
- A test substance is considered negative in the micronucleus test if:
None of the tested concentrations or sampling times showed a statistically significant (P < 0.05) increase in the incidence of micronucleated polychromatic erythrocytes neither in the combined data for both sexes nor in the data for male or female groups separately. - Statistics:
- yes, e.G, Wilcoxon Rank Sum Test; two-sided test at P < 0.05
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- lethargic and rough coat; no abnormalities at 62.5 mg/kg bw
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: toxicity signs (at 125 and 250 mg/kg bw): lethargic behaviour and rough coat
- Remarks:
- no abnormalities at 62.5 mg/kg bw
- Additional information on results:
- - No increase in the frequency of micronucleated polychromatic erythrocytes was observed in the polychromatic erythrocytes of the bone marrow of the animals treated with the test substance. The animals of the groups that received 250 mg/kg bw showed slight decreases in the ratio of polychromatic to normochromatic erythrocytes at the 48 hours sampling time compared to the ratio observed in the animals treated with 62.5 mg/kg bw. This result reflected a toxic effect of the test substance on the erythropoiesis, implying that it reached the bone marrow cells of the mouse.
- Several toxicity signs such as lethargic behaviour and rough coat were observed in mice following the administration of 125.0 and 250.0 mg/kg bw. No abnormalities was recorded in the groups that had received 62.5 mg/kg bw test substance.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was considered to be not clastogenic in mouse (in vivo Mammalian Erythrocyte Micronucleus Test).
- Executive summary:
A study was conducted to determine the in vivo toxicity of the test substance according to OECD Guideline 474 (in vivo Mammalian Erythrocyte Micronucleus Test), in compliance with GLP. Six groups each comprising 5 male and 5 female NMRI mice, received a single intraperitoneal injection of 10 mL/kg bw test substance. Two groups were dosed with 250 mg/kg bw, two groups were dosed with 125 mg/kg bw and two groups were dosed with 62.5 mg/kg bw. One group treated with the vehicle alone (corn oil) or with cyclophosphamide (CPA) at 50 mg/kg bw served as negative and positive controls, respectively. The tissue examinated was the bone marrow. The number of micronucleated polychromatic erythrocytes was counted in 2000 polychromatic erythrocytes. Mortality and toxicity signs were recorded daily. No increase in the frequency of micronucleated polychromatic erythrocytes was observed in the polychromatic erythrocytes of the bone marrow of the animals treated with the test substance. The animals of the groups that received 250 mg/kg bw showed slight decreases in the ratio of polychromatic to normochromatic erythrocytes at the 48 hours sampling time compared to the ratio observed in the animals treated with 62.5 mg/kg bw. This result reflected a toxic effect of the test substance on the erythropoiesis, implying that it reached the bone marrow cells of the mouse. Several toxicity signs such as lethargic behaviour and rough coat were observed in mice following the administration of 125.0 and 250.0 mg/kg bw. No abnormalities was recorded in the groups that had received 62.5 mg/kg bw test substance. Under the study conditions, the test substance was considered to be not clastogenic in mouse (Bertens, 2001).
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