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EC number: 245-509-0 | CAS number: 23235-61-2
- 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 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:
- 06 August 2020 - 14 August 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- updated 26 June 2020
- Deviations:
- yes
- Remarks:
- An impurity allowance of 2.1% was inadvertently employed for the solubility check and Exp. 1. The error was noted on the day of testing and the experiment was abandoned. There was considered no impact to integrity of the test and the study was repeated.
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S2(R1) guideline adopted June 2012 (ICH S2(R1) Federal Register. Adopted 2012; 77:33748-33749)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Japanese Ministry of Health, Labour and Welfare (MHLW), Ministry of Economy, Trade and Industry (METI), and Ministry of the Environment (MOE) Guidelines of 31 March 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- EC Number:
- 245-509-0
- EC Name:
- 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]
- Cas Number:
- 23235-61-2
- Molecular formula:
- C12H26O5
- IUPAC Name:
- 2-ethyl-2-{[2-ethyl-3-hydroxy-2-(hydroxymethyl)propoxy]methyl}propane-1,3-diol
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): Di-Trimethylolpropane, Di-TMP
- Lot/batch No.: 200504133
- Purity: 97.9%
- Appearance: White flakes
- Storage condition of test material: At room temperature in the dark.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Di-Trimethylolpropane, Di-TMP
- Lot/batch No.: 200504133
- Purity: 97.9%
- Appearance: White flakes
- Storage condition of test material: At room temperature in the dark
Method
- Target gene:
- Tryptophan locus
Species / strain
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver homogenate metabolizing system (10% liver S9 in standard co-factors)
- Test concentrations with justification for top dose:
- 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate (Exp. 1: Plate Incorporation Method)
15, 50, 150, 500, 1500 and 5000 μg/plate (Exp. 2: Pre-Incubation Method) - Vehicle / solvent:
- Vehicle: Sterile distilled water
Justification for vehicle/solvent: The Sponsor stated that test item is fully soluble in sterile distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- 10 μg/plate for WP2uvrApKM101 (Direct acting compound in the absence of S9-mix)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- 0.5μg/plate for WP2uvrApKM101 (Indirect acting compound in the presence of S9-mix)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- First experiment: in agar (plate incorporation)
- Second experiment: pre-incubation
TREATMENT AND HARVEST SCHEDULE:
- Pre-incubation period (Exp. 2): incubated at 37 ± 3°C for 20 minutes, with shaking
- Exposure duration: Plates were incubated at 37 ± 3°C for between 48 and 72 hours
OTHER EXAMINATIONS:
- Other: Observation of the number of revertant colonies and bacterial lawns - Evaluation criteria:
- The test item is considered non-mutagenic (negative) in the test system if the below criteria are not met.
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. A fold increase greater than two times the concurrent solvent control (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).
5. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989). - Statistics:
- Dunnett’s Regression Analysis (* = p < 0.05) to confirm statistical significance in increases in frequency of revertant colonies compared to the concurrent solvent control
Results and discussion
Test results
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: not reported
- Data on osmolality: not reported
- Possibility of evaporation from medium: not reported
- Water solubility: Sponsor stated that substance was completely soluble
- Precipitation and time of the determination: not reported
- Other confounding effects: not reported
RANGE-FINDING/SCREENING STUDIES:
No evidence of toxicity was obtained following exposure to Di-TMP. A maximum exposure concentration of 5000 μg/plate was, therefore, selected for use in the second experiment.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mean revertant colony counts for the vehicle controls were within confidence limits of the current historical control range of the laboratory.
Applicant's summary and conclusion
- Conclusions:
- Negative: under the conditions of this test Di-Trimethylolpropane was considered to be non-mutagenic.
- Executive summary:
A bacterial reverse mutation test was performed by Covance Laboratories Limited, U.K., on behalf of Perstorp Holding AB, Sweden, to determine the potential of the test substance Di-Trimethylolpropane (Di-TMP) to induce gene mutation. The test was performed in accordance with OECD, EC, US EPA, Japanese, and other international test guidelines, and the test was carried out to GLP. Only one strain of Escherichia coli (WP2uvrA pKM101) was tested in this study to compliment previous testing performed on this (Jensen, 1992). No evidence of cytotoxicity or mutagenic activity was observed during two tests, either in the presence or absence of S9 metabolic activation at concentrations up to and including the limit concentration of 5000 ug/plate.
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