Ethyl(methyl)amine

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:

July 1994-November 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl(methyl)amine

EC Number:

210-862-1

EC Name:

Ethyl(methyl)amine

Cas Number:

624-78-2

Molecular formula:

C3H9N

IUPAC Name:

ethyl(methyl)amine

Method

Target gene:

no applicable

Species / strain

Species / strain / cell type:

other: strains: TA 1535, TA 1537, TA 98, TA 100, TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9 mix from aroclor 1254-induced rat liver (5%)

Test concentrations with justification for top dose:

Toxicity study (24h): 0.075-0.1-0.1-0.25-0.5-1-5
Toxicity study (48h): 0.5-1-5-10-20/0.05-0.075-0.1-0.25-0.5
Genotoxicity study (48h): 0.05-0.075-0.1-0.25-0.5

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

no

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

mitomycin C

Controls 2

Positive control substance:

other: 9-aminoacridine, with metabolic activation : 2-aminoanthracene and Danthron

Details on test system and experimental conditions:

IUCLID4 Type: Salmonella typhimurium reverse mutation assay

Results and discussion

Test results

Key result

Species / strain:

other: TA1535,TA1537, TA98,TA100, TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

see tables attached

Remarks on result:

other: other: strains: TA 1535, TA 1537, TA 98, TA 100, TA 102

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Toxicity
After 24-pour and 48-hour treatments:
Highly toxic effect on TA 98 and TA 100 without S-9 mix from
0.5% upwards.

Genotoxicity study
No genotoxic effect whatever the concentration tested with
and without S9 mix, on the five tester strains.

Positive controls induced a marked increase in the revertant
colonies/plate for all strains.

Applicant's summary and conclusion

Conclusions:

Ethylmethylamine was not genotoxic in the Ames test.

Executive summary:

The genotoxic potential of ethylmethylamine was assessed by the Ames test on five Salmonella

typhimurium tester strains: TA1535, TA1537, TA98, TAIOO and TA102, both in the absence and

presence of metabolic activation.

Ethylmethylamine, a liquid volatile compound, was tested as a gas at concentrations (v/v)

ranging from 0.05 to 20%.

In the preliminary toxicity assay performed on TA98 and TAIOO with and without metabolic

activation, ethylmethylamine induced a marked toxic effect from 0.5% upwards after a 48-hour

treatment. In a second toxicity study performed on TA98 and TAlOO without S-9 mix at

concentrations of 0.075, 0.1, 0.25, 0.5, l and 5% with a 24-hour treatment, and at 0.05, 0.075,

0.1, 0.25 and 0_.5% with a 48-hour treatment, ethylmethylamine induced a marked toxic effect

from 0.5% upwards whatever the treatment duration.

Consequently, the 48-hour treatment was retained for the two genotoxicity studies and the

concentrations selected were 0.05, 0.075, 0.1, 0.25 and 0.5%.

A slight toxic effect was observ.ed on His+ revertant colonies, at the concentration of 0.5%,

depending on the tester strain.

Whether in the presence or in the absence of metabolic activation, no increase was observed in

the number of His+ revertant colonies/plate at any of the concentrations tested, on the five

Salmonella typhimurium tester strains during the two geno.toxicity studies.

In conclusion, ethylmethylamine was not genotoxic in the Ames test, with and without metabolic

activation, when tested as a gas.