N,N-diethyl-2-propynylamine

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:

Not specified

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-diethyl-2-propynylamine

EC Number:

223-804-5

EC Name:

N,N-diethyl-2-propynylamine

Cas Number:

4079-68-9

Molecular formula:

C7H13N

IUPAC Name:

diethyl(prop-2-yn-1-yl)amine

Specific details on test material used for the study:

- Name of the test substance used in the study report: Golpanol DEP
- Batch No.: Partie 5-6-7
- Test substance No.: 90/309
- Purity: > 98%
- Storage: Room temperature

Method

Target gene:

his and trp

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9 mix

Test concentrations with justification for top dose:

20, 100, 500, 250 and 5000 µg/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

other: with S-9: 2-aminoanthracene; without S-9: N-methyl-N'-nitro-N-nitrosoguanidine (TA 100 and TA 1535), 4-nitro-o-phenylendiamine (TA 98), 9-aminoacridine chloride monohydrate (TA 1537)

Details on test system and experimental conditions:

STANDARD PLATE
Test tubes containing 2 mL portions of soft agar which consists of 100 mL agar (0.6% agar + 0.6 % NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at 45°C, and the remaining components are added in the following order:
0.1 mL test solution
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 (minimal glucose agar plates) within approx. 30 seconds.

PREINCUBATION TEST
0.1 mL test solution, 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 agar plates within approx. 30 seconds.

BOTH TESTS
In each experiment 3 test plates per dose or per control were used. After incubation at 37°C for 48 hours in the dark, the bacterial colonies (his+ / trp+ revertants) are counted. The titer is determined only in the experiments with S-9 mix both without test substance (solvent only) and after adding the two highest amounts of substance. Sterility control was performed.

Evaluation criteria:

A substance to be characterized as positive in the bacterial tests, has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results

Key result

Species / strain:

other: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA

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:

An increase in the number of his+ or trp+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolisation system.

Applicant's summary and conclusion

Conclusions:

According to the results of the present study, the test substance is not mutagenic in the Ames test and in the Escherichia coli reverse mutation assay under the experimental conditions chosen here.