Ethyldimethylamine

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:

from 1989-10-12 to 1989-12-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD N°471 Guideline (1983 May 26th)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ethyldimethylamine

EC Number:

209-940-8

EC Name:

Ethyldimethylamine

Cas Number:

598-56-1

Molecular formula:

C4H11N

IUPAC Name:

ethyldimethylamine

Details on test material:

- Name of test material (as cited in study report): Dimethylethylamine (DMEA)
- Physical state: liquid
- Analytical purity: 99.54%
- Purity test date: 1989-07-20
- Lot/batch No.: 8907P0193
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: stable under standard conditions
- Other: origin: Usine La Chambre

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix from Aroclor 1254-induced rat liver (10%)

Test concentrations with justification for top dose:

100, 500, 1000, 2500, 5000 ug/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: solubility

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S9: sodium azide (TA100, TA1535), 2-nitrofluorene (TA98, TA1538), 9-aminoacridine (TA1537). +S9: 2-aminoanthracene (all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20minutes at 37°C (0.1mL of the test item solution + 0.5mL of phosphat e buffer 0.2M or S09mix + 0.1mL of bacteria)
- Fixation time (start of exposure up to fixation or harvest of cells): 48hours

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, number of revertant colonies

Evaluation criteria:

dose dependent increase in the number of revertant colonies

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 2500 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

negative.

Under these experimental conditions, DMEA is not mutagenic
in S.typhimurium in Ames test.

Executive summary:

The genotoxic activity of Dimethylethylamine DMEA is evaluated in the Ames test on Salmonella typhimurium according to the OECD 471 guideline. Doses of 100, 500, 1000, 2500, 5000 ug/plate are tested on five strains (TA 98, TA 100, TA 1535, TA 1537 and TA 1538) according to the preincubation method (20 min at 37°C). The number of revertants colonies is evaluated 48 to 72 hours later.

Cytotoxicity was observed for the highest dose (5000µg/plate) with and without metabolic activation in all strain. No genotoxic activity was observed for all doses with and without metabolic activation on the 5 tested strains.

In conclusion, Dimethylethylamine did not induce genotoxicity in the Ames test on Salmonella typhimurium in the absence and presence of metabolic activation.