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EC number: 225-306-3 | CAS number: 4767-03-7
- 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
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- 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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May 1998 - 10 June 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed to OECD and EC test guidelines and according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Netherlands GLP Compliance Monitoring Programme
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2-bis(hydroxymethyl)propionic acid
- EC Number:
- 225-306-3
- EC Name:
- 2,2-bis(hydroxymethyl)propionic acid
- Cas Number:
- 4767-03-7
- Molecular formula:
- C5H10O4
- IUPAC Name:
- 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid
- Reference substance name:
- 2,2-dimethylol propionic acid (DMPA)
- IUPAC Name:
- 2,2-dimethylol propionic acid (DMPA)
- Reference substance name:
- DMPA
- IUPAC Name:
- DMPA
- Details on test material:
- 2,2-dimethylol propionic acid (DMPA), supplied by Mallinckrodt as a free flowing granular solid, off-white in colour, impurities (identity and concentrations): moisture, 0.13%; ash, 0.008%. Lot/batch No.: DO 374. The material was stored under ambient conditions.
Constituent 1
Constituent 2
Constituent 3
Method
- Target gene:
- TA98: His D3052, TA100: His G46, TA1535: His G46, TA1537: His C3076.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix obtained from the livers of male Wistar rats injected i.p. with Arocolor 1254
- Test concentrations with justification for top dose:
- Nominal concentrations: 0, 62, 185, 556, 1667, 5000 µg/plate
- Vehicle / solvent:
- Water: Just before use, a stock solution of the test substance was prepared in water at 50000 µg/ml, resulting in a clear solution. Thereafter, the stock solution was sterilised by passage through a micorpore filter and serial dilutions were prepared in water.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 1.0 µg/plate; positive control for strains TA1535 and TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 80 µg/plate; positive control for strain TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 2.0 µg/plate; positive control for strain TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 2.0 µg/plate; positive control for strains TA1535, TA98, and TA100 in the presence of S9-mix.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 4.0 µg/plate; positive control for strain TA1537 in the presence of S9-mix.
- Details on test system and experimental conditions:
- Two independent mutagenicity assays were performed. A preliminary toxicity test was not conducted, because excessive toxicity was not expected. Therefore, the toxicity test was incorporated into the first mutagenicity assay.
Frozen stocks of each strain were checked for histidine or tryptophan requirement and for sensitivity to ampicillin, crystal violet and UV radiation.
To 2 ml molten top agar (containing 0.6% agar, 0.5% NaCl and 0.05 mM L-histidine.HCl/0.05 mM biotin), maintained at 46°C, were added subsequently:0.1 ml of a fully grown culture of the appropriate tester strain, 0.1 ml of the appropriate dilution of the test substance or of the negative control (vehicle: water), of or the positive control substance and 0.5 ml S9 mix or 0.5 ml sodium phosphate 100 m (pH7.4) as appropriate. The ingredients were thoroughly mixed and the mix was immediately poured onto minimal glucose agar plates (1.5% agar in Vogel and Bonner medium E with 2% glucose). All determinations were made in triplicate. The plates were incubated at c. 37°C for 3 days. Revertant colonies were then counted. - Evaluation criteria:
- A reproducible two-fold or greater increase in the mean number of revertant colonies appearing in the test plates over and above the background
spontaneous reversion rate observed in the vehicle, or a demonstrable concentration-related effect, was taken to indicate a positive response in this assay system. - Statistics:
- No statistical analysis was performed; not required for this study type
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The substance was not toxic to the bacteria (evidenced by the absence of a drastic decrease in the mean number of revertant colonies).
In both the absence and presence of S9 mix in all strains tested, the test substance did not cause a reproducible two-fold or greater increase in the mean number of revertant colonies appearing in the test plates compared to the background spontaneous reversion rate observed with the vehicle, and did not give evidence of a dose response. The positive controls gave the expected increase in the mean number of his+ revertants both with and without S9. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
It was concluded that 2,2 -dimethylol propionic acid is not mutagenic up to concentrations of 5000 µg/plate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
It was concluded that the results obtained with the test substance 2,2-dimethylol propionic acid (DPMA) in Salmonella typhimurium strains TA 1535,
TA 1537, TA 98, and TA 100, in both the absence and in the presence of the S9-mix indicate that 2,2-dimethylol propionic acid (DMPA) was not
mutagenic under the conditions employed in this study. - Executive summary:
A study was conducted by TNO Nutrition and Food Research Institute, Netherlands on behalf of Mallinckrodt Chemical GmbH, Germany, to assess the potential of the the test substance 2,2 -dimethylol propionic acid (DMPA) to cause genetic damage. A bacterial reverse mutation test was performed in several Salmonella typhimurium strains (TA1535, TA1537, TA98 and TA100), both with and without metabolic activation. The study was performed to GLP and according to OECD 471 and EC B14 Test Guidelines. There was no evidence of toxicity, or mutagenicity up to concentrations of 5000 µg/plate. Therefore it was concluded that 2,2 -dimethylol propionic acid was not mutagenic under the conditions of the study.
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