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EC number: 406-880-6 | CAS number: 88917-22-0 ACETATE DPMA ACROSOLV; ACROSOLV DPMA ACETAT; ACROSOLV DPMA ACETATE; DOWANOL DPMA; DOWANOL DPMA GLYCOL ETHER; DOWANOL DPMA GLYKOL ETHER; ETHER DE GLYCOL DPMA DOWANOL
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- other: KIHATSU No 603; Test guidelines for bacterial mutagenic testing, (Notice No 77, 1 September 1988, Ministry of Labour, amended subsequently by Notice No 67, 2 June 1997, and KIHATSU No 413, 2 June 1997)
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- his-/his+
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: not specified in the report
- Periodically "cleansed" against high spontaneous background: not specified in the report - Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: not specified in the report
- Periodically "cleansed" against high spontaneous background: not specified in the report - Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: not specified in the report
- Periodically "cleansed" against high spontaneous background: not specified in the report - Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: not specified in the report
- Periodically "cleansed" against high spontaneous background: not specified in the report - Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 metabolic activation system
- Test concentrations with justification for top dose:
- Dose range-finding study: 0, 19.5, 78.1, 313, 1250, or 5000 ug/plate
Main study: 0, 313, 635, 1250, 2500, or 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: As DPMA was easily soluble in water, injection water (Lot No. 99J14A) was used as the solvent. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: AF-2, 9-aminoacridine, sodium azide and 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: 2 per concentration
NUMBER OF CELLS EVALUATED: not specified in the report
DETERMINATION OF CYTOTOXICITY
- Method: number of colonies
Frozen stock cultures of Salmonella typhimurium were transferred to nutrient rich broth and incubated at 37°C until reaching a cell density between 1 and 2E9 cells/ml for each of the four tester strains (TA98, TA100, TA1535, & TA1537).
Results were considered positive if the number of colonies exceeded twice background for any of the strains at any dose and if a dose-response relationship was observed in any strain, with or without S-9 activation. In addition the positive response had to be reproducible in a second experiment. Results were considered negative if the revertant counts did not exceed twice background for any tester strain and the negative response was reproducible in a second experiment - Evaluation criteria:
- For a test to be considered valid, if each value of positive and negative control plates remained within the standard range calculated from the background data and there was no abnormal finding in the sterility test.
If the treatment plate did not show any growth inhibition caused at least a doubling of mean revertany colonies over the negative control and the reproducible positive results were observed in dose dependent way, it was concluded as a mutagenic activity. - Species / strain:
- other: Salmonella typhimurium (strains TA98, TA100, TA1535 and TA1537) and Escherichia coli, strain (WP2uvrA)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Not toxic at highest concentration.
- Remarks on result:
- other: strain/cell type: Salmonella typhimurium (strains TA98, TA100, TA1535 and TA1537) and Escherichia coli, strain (WP2uvrA)
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
DPMA did not induce a mutagenic response in any tester strain at any concentration, with or without S-9 metabolic activation and toxicity did not interfere with the assay and negative and positive controls fell within historical control limits - Executive summary:
Test substance, DPMA was tested for mutagenic potential using histidine dependent autotrophic mutants of Salmonella typhimurium, strains TA 98, TA1537, and TA100, and a tryptophan dependent mutant of Escherichia coli, strain WP2uvrA in two independent mutation tests in the presence (with metabolic activity) and absence (without metabolic activity) of liver preparations (S9-mix) by preincubation method.
DPMA dissolved in the distilled water for injection (Japan Pharmacopoeia) up to 5000 μg/plate were tested, and 6 dose levels were separated by 2 of common ratio in the preliminary study. In the definitive study, 5000μg/plate was a highest dose level and then 5 dose levels were selected by 4 of common ratio as set those in the preliminary test.
No evidence of mutagenic activity to show the increases in the reverse mutation colonies exceeding 2 folds of those of negative control value was seen at any dose level off DPMA in either mutation test. The values calculated for the concurrent negative and positive controls of each strain were within the range of the background data.
Under the conditions of the study, it was concluded that DPMA shows no evidence of mutagenic activity in this bacterial system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
DPMA was negative for genotoxicity in all available studies.
Justification for selection of genetic toxicity endpoint
An OECD guideline, reliability 1 GLP study
Justification for classification or non-classification
All in vitro mutagenicity studies with the test substance were negative, therefore dipropylene glycol methyl ether acetate is not classified for genotoxicity.
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