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EC number: 201-155-9 | CAS number: 78-90-0
- Life Cycle description
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- Ecotoxicological Summary
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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:
- 04 Feb 2014 - 21 Feb 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- yes
- Remarks:
- only E. coli strain tested
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Propylenediamine
- EC Number:
- 201-155-9
- EC Name:
- Propylenediamine
- Cas Number:
- 78-90-0
- Molecular formula:
- C3H10N2
- IUPAC Name:
- propane-1,2-diamine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 1,2-Propylendiamin techn.
- Physical state: colorless clear liquid
- Analytical purity: 99.7 %
- Lot/batch No.: 000STD77L0
- Storage condition of test material: room temperature
- Stability: The stability of the test substance under storage conditions throughout the study period was guaranteed by the manufacturer until 04 Nov 2015; the manufacturer holds this responsibility
Constituent 1
Method
- Target gene:
- trp operon for the E. coli strain
Species / strain
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver mix prepared from Wistar rats treated with 80 mg/kg bw phenobarbital i.p. and β-naphthoflavone orally, each on three consecutive days.
- Test concentrations with justification for top dose:
- First experiment (standard plate test, with and without metabolic activation, 3 plates/dose or control): 0, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Second experiment (preincubation test with and without metabolic activation, 3 plates/dose or control): 0, 33, 100, 333, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: due to the limited solubility of the test substance in water, DMSO was used as vehicle.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- sterility control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with S9-mix
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- 60 µg/plate in DMSO
- Positive controls:
- yes
- Remarks:
- without S9-mix
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- 5 µg/plate in DMSO
- Details on test system and experimental conditions:
- STANDARD PLATE TEST (SPT)
According to Ames et al., Mut Res 31: 347-364 (1975) and Maron & Ames, Mut Res 113: 173-215 (1983)
In the standard plate test, tubes were filled with 2mL portions of soft agar and kept in a water bath at 42 to 45°C. This soft agar consisted of 100 mL agar and 10 mL amino acid solution.
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 Merckoplate® (minimal glucose agar plates) plate and incubated for 48 - 72 hrs in the dark at 37°C.
PREINCUBATION TEST (PIT)
According to Yahagi et al. Mut Res 48: 121-129 (1977) and Matsushima et al., In: Norpoth, K.H. and R.C. Garner, Short-Term Test Systems for Detecting Carcinogens, Springer Verlag Berlin, Heidelberg, New York (1980)
For the preincubation test 0.1 mL test solution or vehicle, 0.1 mL bacterial suspension and 0.5 mL of either S9 mix or phosphate buffer 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. - Evaluation criteria:
- Acceptance criteria
Generally, the experiment was considered valid if the following criteria were met:
• The number of revertant colonies in the negative controls was within the range of the
historical negative control data for the tester strain.
• The sterility controls revealed no indication of bacterial contamination (see Appendix 3).
• The positive control substances both with and without S9 mix induced a distinct increase in
the number of revertant colonies within the range of the historical positive control data or
above.
• Fresh bacterial culture containing approximately 109 cells per mL were used.
Assessment criteria
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least
doubling of the spontaneous mutation rate in at least in the tester strain either without
S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for the tester strains were within the historical negative control
data range under all experimental conditions in at least two experiments carried out
independently of each other.
Results and discussion
Test results
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- no increase in number of revertants was observed
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from about 2500 µg/plate onward
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- other: sterility control, yes
- Positive controls validity:
- valid
- Additional information on results:
- A biologically relevant increase in the number of trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.
No bacteriotoxic effect was observed in the standard plate test.
In the preincubation assay bacteriotoxicity (reduced trp- background growth, slight decrease in the number of trp+ revertants) was occasionally observed depending on the test conditions from about 2 500 μg/plate onward.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance is not mutagenic in the Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of Escherichia coli WP2 uvrA, in a reverse mutation assay. The test concentrations were 0, 33, 100, 333, 1000, 2500, and 5000 µg/plate for the standard plate test with and without S9 mix, and for the preincubation test with and without S9 mix, respectively. Negative (sterility and solvent) and positive controls were considered.
Precipitation of the test substance was found from about 2 500 μg/plate onward with and without S9 mix. A weak bacteriotoxic effect was occasionally observed depending on the test conditions from about 2 500 μg/plate
onward.
A biologically relevant increase in the number of trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.
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