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EC number: 213-139-9 | CAS number: 926-63-6
- 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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 June 1999 - 14 July 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Dimethyl(propyl)amine
- EC Number:
- 213-139-9
- EC Name:
- Dimethyl(propyl)amine
- Cas Number:
- 926-63-6
- Molecular formula:
- C5H13N
- IUPAC Name:
- dimethyl(propyl)amine
- Details on test material:
- - Name of test material (as cited in study report): Dimethylpropylamin
- Physical state: liquid, colourless, clear
- Analytical purity: 99.4% (GC)
- Lot/batch No.: K 322/1
- Storage condition of test material: room temperature, under N2
Constituent 1
Method
- Target gene:
- his operon for S. typhimurium strains
trp operon for the E. coli strain
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: TA 98: rfa-, uvrB-, R-factor; TA 100: rfa-, uvrB-, R-factor; TA 1535: rfa-, uvrB-; TA 1537: rfa-, uvrB; WP2: trp-; uvr A-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver mix prepared from Sprague-Dawley rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- First experiment (standard plate test, with and without metabolic activation): 0, 20, 100, 500, 2500 and 5000 µg/plate
Second experiment (preincubation test with and without metabolic activation): 0, 20, 100, 500, 2500 and 5000 µg/plate
Third experiment (preincubation test without metabolic activation): 0, 125, 250, 500, 1000 and 1500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (sterility control)
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with S9-mix
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- 2.5 µg/plate, in DMSO, for TA 1535, TA 1537, TA 100, TA 98; 60 µg/plate, in DMSO, for E. coli WP2 uvrA
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- 5 µg/plate, in DMSO, for TA 1535 and TA 100
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 100 µg/plate, in DMSO, for TA 1537 Migrated to IUCLID6: (AAC)
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 5 µg/plate, in DMSO, for E. coli WP2 uvrA Migrated to IUCLID6: (4-NQO)
- Positive controls:
- yes
- Remarks:
- (without S9-mix)
- Positive control substance:
- other: 4-nitro-o-phenylendiamine (NOPD)
- Remarks:
- 10 µg/plate, in DMSO, for TA 98
- Details on test system and experimental conditions:
- In the standard plate test, tubes were filled with 2mL portions of soft agar and kept in a water bath at 45°C. This soft agar consisted of 100 mL agar and 10 mL amino acid solution. As amino acid solution for the soft agar was used 0.5 mM histidine and 0.5 mM biotin for TA strains and 0.5 mM tryptophan for the E. coli strain.
Then following components are added:
0.1 ml test solution or vehicle
0.1 ml fresh bacterial culture
0.5 ml S9 -mix or phosphate buffer
After mixing samples were poured onto Vogel-Bonner (minimal glucose agar plates) plate and incubated for 48 - 72 hrs in the dark at 37°C.
For the preincubation test 0.1 mL test solution or vehicle, 0.1 mL bacterial suspension and 0.5 mL of the S9 mix were incubated at 37°C for 20 minutes. After addition of 2 mL soft agar samples were poured onto agar plates and incubated again at 37°C for 48 to 72 hrs.
For the E. coli strain, plate test differed again in mixture of amino acid solution of the soft agar, the histidine component used for the TA strains being replaced by tryptophan.
Triplicate testing is done. - Evaluation criteria:
- An assay is accepted when the following criteria are met:
1.) number of colonies in the negative control is in the historical control range
2.) no indication of bacterial contamination (checked by sterility control)
3.) number of colonies in the positive controls are in the range of historical control data
4.) titer of viable bacteria is ≥ 10 E+9/mL
Toxicity is detected by:
1.) decrease in the number of revertants
2.) titer reduction
3.) clearing or diminution of the background lawn
Precipitation:
As long as no interference between precipitation and colony counting occurs is 5 mg/plate set as maximum dose even for relatively insoluble compounds.
A test chemical is to be considered as mutagenic when:
1.) increase of number of revertant colonies is reproducible and dose-related.
2.) in at least 1 tester strain doubling of colony counts with or without S-9 mix or after adding a metabolizing system is seen.
A test chemical is to be considered as non-mutagenic when:
1.) the number of revertants is inside the range of historical negative control data in 2 experiments performed independently from each other.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no increase in number of revertants was observed
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in preincubation test only (for detail see 'additional information on results')
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Precipitation: no precipitation detected
Cytotoxicity: no cytotoxic effects were seen in the standard plate-incorporation test with and without metabolic activation. In the tests with preincubation but without metabolic activation cytotoxicty occurred at
1.) 1500 µg/ plate (ratio of number of revertants for test and control data < 0.5 ) for strain TA98
2.) 5000 µg/ plate (ratio of number of revertants for test and control data < 0.5 ) for strain E. coli WP2
3.) 2500 µg/ plate (reduced background growth) for strains TA 1535, TA 100, TA 1537 and TA 98
In the tests with preincubation and metabolic activation cytotoxicty occurred at 5000 µg/plate (reduced background growth) for strains TA 1535, TA 100, TA 1537 and TA 98
Any other information on results incl. tables
Experiment 1: Standard plate-incorporation test
SPT without S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/plate] | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA |
Solvent control | 18 | 120 | 11 | 32 | 27 |
20 | 17 | 119 | 12 | 28 | 25 |
100 | 19 | 133 | 13 | 28 | 25 |
500 | 17 | 118 | 13 | 25 | 26 |
2500 | 18 | 120 | 13 | 29 | 28 |
5000 | 20 | 116 | 17 | 27 | 33 |
Positive control | 689 | 1252 | 988 | 1218 | 1028 |
SPT with S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/ plate] | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA |
Solvent control | 19 | 131 | 17 | 41 | 28 |
20 | 19 | 135 | 17 | 32 | 26 |
100 | 19 | 130 | 12 | 35 | 27 |
500 | 21 | 139 | 11 | 32 | 27 |
2500 | 15 | 118 | 11 | 36 | 25 |
5000 | 14 | 126 | 12 | 33 | 30 |
Positive control | 203 | 1088 | 141 | 1070 | 202 |
Experiment 2: Preincubation test PIT without S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/ plate] | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA |
Solvent control | 20 | 125 | 11 | 28 | 27 |
20 | 17 | 132 | 10 | 27 | 24 |
100 | 18 | 144 | 13 | 25 | 36 |
500 | 17 | 136 | 9 | 24 | 32 |
2500 | B | B | B | B | 24 |
5000 | B | B | B | B | 13 |
Positive control | 1174 | 1082 | 759 | 1230 | 558 |
PIT with S9-Mix [mean no. of mutations/ plate] |
|||||
Dosage [µg/ plate] | TA 1535 | TA 100 | TA 1537 | TA 98 | WP2 uvrA |
Solvent control | 19 | 136 | 10 | 40 | 37 |
20 | 17 | 140 | 10 | 37 | 35 |
100 | 18 | 136 | 9 | 31 | 39 |
500 | 16 | 132 | 11 | 32 | 45 |
2500 | 16 | 132 | 9 | 30 | 44 |
5000 | B | 75 | 3 | 25 | 35 |
Positive control | 100 | 640 | 96 | 722 | 244 |
Experiment 3: PIT without S9-mix | |||||
Dosage [µg/ plate] | TA 1535 | TA 100 | TA 1537 | TA 98 | |
Solvent control | 20 | 136 | 8 | 27 | |
125 | 19 | 124 | 10 | 30 | |
250 | 19 | 117 | 7 | 20 | |
500 | 15 | 118 | 8 | 19 | |
1000 | 16 | 110 | 7 | 23 | |
1500 | 15 | 92 | 7 | 14 | |
Positive control | 1027 | 1177 | 717 | 1158 | |
B: reduced background growth, cytotoxicity |
Applicant's summary and conclusion
- Conclusions:
- A test of bacterial gene mutagenicity was conducted for DMPA according to the OECD TG 471 (1997), with following strains: TA 98, TA 100, TA 1535 and TA 1537 and E. coli WP2 uvrA . The test concentrations were 20, 100, 500, 2500 and 5000 µg/plate for the standard plate test with and without S9 mix, and for the first preincubation test with and without S9 mix. The concentrations were 125, 250, 500, 1000 and 1500 µg/plate for second preincubation test conducted without S9 mix.
In none of the tests any mutagenic effect could be detected. Therefore the substance is to be considered as non-mutagenic in bacteria.
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