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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. The strains E.Coli WP2 or TA102 are missing. However the study is still suficient for evaluation of nutagenicity in bacterial testsystems

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
E.Coli WP2 or TA102 are missing
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3-dimethylaminopropiononitrile
EC Number:
217-090-4
EC Name:
3-dimethylaminopropiononitrile
Cas Number:
1738-25-6
Molecular formula:
C5H10N2
IUPAC Name:
3-(dimethylamino)propanenitrile
Details on test material:
TS-Freetext:
3-Dimethylaminopropionitril
- Name of test material (as cited in study report): Dimethylaminopropionitril
- Analytical purity: >=98%
- Storage condition of test material: Room temperature

Method

Target gene:
his-
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:
S-9 mix from Aroclor 1254 induced rat liver
Test concentrations with justification for top dose:
20 µg - 5000 µg/plate
Vehicle / solvent:
Aqua dest.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: see free text
Details on test system and experimental conditions:
Experiment 1: Standard plate test
Test tubes containing 2 ml soft agar kept in a water bath at 45°C, and remaining
components added in the following order:
0.1 ml test solution or vehicle
0.1 ml bacterial suspension
0.5 ml S-9 mix (in tests with metabolic activation) or 0.5 ml phosphate buffer (in tests
without metabolic activation).
After mixing, the samples are poured onto Vogel-Bonner agar plates.

Experiment 2: Preincubation assay
0.1 ml test solution or vehicle, 0.1 ml bacterial suspension and 0.5 ml S-9 mix are
incubated at 37°C for the duration of 20 minutes. Subsequently, 2 ml of soft agar is added
and, after mixing, the samples are poured onto the Vogel-Bonner agar plates.

Experiment1&2
In each experiment 3 test plates per dose or per control used; after incubation at 37°C for
48 hours in the dark, the bacterial colonies (his+ revertants) are counted.
Positive control:
with metabolic activation: 10 μg/plate 2-aminoanthracene for each strain;
without metabolic activation: 5 μg/plate N-methyl-N'-nitro-N-nitrosoguanidine for TA 100 and TA 1535, 10 μg/plate 4-nitro-o-phenylendiamine
for TA 98, 100 μg/plate 9-aminoacridine chloride monohydrate for TA 1537; all substances were dissolved in DMSO.
The titer was determined and in regularly intervals the strain characteristics were checked. Sterility control was performed.
Evaluation criteria:
Positive results
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the result

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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Complete solubility of the test substance in aqua dest.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA 98 TA 100 TA 1535 TA 1537

Applicant's summary and conclusion