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EC number: 219-606-3 | CAS number: 2478-10-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
- Reference Type:
- secondary source
- Title:
- OECD SIDS Hydroxypropyl acrylate, CAS No. 25584-83-2.
- Author:
- OECD SIDS
- Year:
- 2 006
- Bibliographic source:
- OECD SIDS for SIAM 20, UNEP Publications, October 2006.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Acrylic acid, monoester with propane-1,2-diol
- EC Number:
- 247-118-0
- EC Name:
- Acrylic acid, monoester with propane-1,2-diol
- Cas Number:
- 25584-83-2
- Molecular formula:
- C6H10O3
- IUPAC Name:
- Reaction mass of 2-hydroxy-1-methylethyl acrylate and 2-hydroxypropyl acrylate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-Hydroxypropylacrylate
- Analytical purity: 97.8 %
- Batch No. 790201167; Lot No. 32114707
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman, D-33178 Borchen
- Assigned to test groups randomly: yes
- Housing: 5 animals of identical sex/cage
- Diet (ad libitum): pelleted standard diet (Altromin, D-32791 Lage/Lippe)
- Water (ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle/solvent used: CMC (carboxymethyl cellulose)
- Amount of vehicle: 33 mL/kg bw - Duration of treatment / exposure:
- single doses
- Frequency of treatment:
- once
- Post exposure period:
- not applicable
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 600 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: single i.p. injection of 10 mL/kg bw cyclophosphamide in 0.9 % NaCl.
- Doses / concentrations: 30 mg/kg b.w
Examinations
- Tissues and cell types examined:
- One bone marrow smear was prepared per animal from the tissue cleared from each femur.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
An initial experiment to determine the toxicity of the test substance was conducted. Three male and three female mice were administered the test
substance orally at 1000 mg/kg b.w. This dose resulted in only slight toxicity and was therefore chosen as the top dose. In the main experiment,
two animals died within the first 6 hours of dosing at 1000 mg/kg b.w. so a dose of 600 mg/kg b.w. was chosen as the highest dose that could be used for analysis of micronuclei. All 10 mice at 1000 mg/kg b.w. died within 24 hours of dosing.
TREATMENT AND SAMPLING TIMES:
Five males and five females from each group were sacrificed 24 hours after dosing. Forty eight hours after dosing five animals per sex from the 600 mg/kg dose level were killed.
DETAILS OF SLIDE PREPARATION:
Stained smears were examined by light microscopy for incidence of micronucleated cells per 2000 polychromatic erythrocytes per animal. To describe a cytotoxic effect, the ratio of polychromatic to normochromatic erythrocytes was assessed by the examination of at least 1000 erythrocytes.
- Evaluation criteria:
- Evaluation of Results:
Cells were evaluated for large (aneugenic effects) and small (clastogenic effects) micronuclei. The test substance was classified as mutagenic if it induced either a statistically significant (Mann-Whitney test), dose-related increase in the number of micronucleated polychromatic erythrocytes or a reproducible, statistically significant positive response for at least one of the test points. - Statistics:
- Mann-Whitney test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- 600 mg/kg bw
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
The ratio of normochromatic to polychromatic erythrocytes was slightly affected by the treatment with 2-hydroxypropyl acrylate at a dose of 600 mg/kg bw (at 24 and 48 hours in male mice and at 48 hours in female mice). At this dose level, only slight toxic effects, as evidenced by reduced spontaneous reactivity, were obtained up to 6 hours after dosing. There was no increase in the frequency of micronuclei at any dose level at either 24- or 48-hours after dosing compared to the negative control group.
The positive control compound, cyclophosphamide, produced significantly increased frequencies of micronucleated polychromatic and normochromatic erythrocytes.
Following are the results:
Males sacrificed at 24 hours:
|
Mean Micronuclei/2000 PCE |
|
|
Dose group |
All (%) |
Small (%) |
Mean PCE/NCE |
Negative control |
3.2 (0.16) |
2.8 (0.14) |
1000/873.6 |
600 mg/kg bw |
4.4 (0.22) |
3.8 (0.19) |
1000/1056.8 |
300 mg/kg bw |
5.4 (0.27) |
5.4 (0.27) |
1000/1177.6 |
100 mg/kg bw |
4.8 (0.24) |
3.8 (0.19) |
1000/974.6 |
Positive control |
20.2 (1.01) |
18.8 (0.94) |
1000/739.6 |
Females sacrificed at 24 hours:
|
Mean Micronuclei/2000 PCE |
|
|
Dose group |
All (%) |
Small (%) |
Mean PCE/NCE |
Negative control |
3.2 (0.16) |
2.8 (0.14) |
1000/737.4 |
600 mg/kg bw |
2.8 (0.14) |
2.0 (0.10) |
1000/854.6 |
300 mg/kg bw |
5.2 (0.26) |
4.8 (0.24) |
1000/773.8 |
100 mg/kg bw |
3.2 (0.16) |
2.8 (0.14) |
1000/918.8 |
Positive control |
19.6 (0.98) |
18.4 (0.92) |
1000/688.6 |
Males and Females sacrificed at 48 hours:
|
Mean Micronuclei/2000 PCE |
|
|
Dose group |
All (%) |
Small (%) |
Mean PCE/NCE |
600 mg/kg bw males |
2.2 (0.11) |
2.0 (0.10) |
1000/986.2 |
600 mg/kg bw females |
2.2 (0.11) |
1.8 (0.09) |
1000/1065.4 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.