2-chloroacetamide

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:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test was perfomed non-GLP and limited details were available, however it was performed according to valid standard methods at the time of conduct, therefore it is considered relevant, reliable and adequate for classification.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

4 strains

Principles of method if other than guideline:

Hoechst AG Guideline

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-chloroacetamide

EC Number:

201-174-2

EC Name:

2-chloroacetamide

Cas Number:

79-07-2

Molecular formula:

C2H4ClNO

IUPAC Name:

2-chloroacetamide

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Chloracetamid ; compound 128/79
- Other: Technical substance, provided by the manufacturing plant (Gersthofen)

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

4 - 2500 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: Procarbazine-HCl

Remarks:

without S9

Controls 2

Positive controls:

yes

Positive control substance:

other: Streptozotocin

Remarks:

without S9

Controls 3

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without S9

Controls 4

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation

DURATION: Exposure duration: 48 h at 37°C

SELECTION AGENT (mutation assays): histidine

NUMBER OF REPLICATIONS: 4

DETERMINATION OF MUTAGENICITY
- Method: number of colonies growing on each plate

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

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Chloroacetamide tested with bacterial strains Salmonella typhimurium TA 98, TA100, TA1535 and TA1537 showed no mutagenicity neither in the presence nor absence of rat liver preparation at concentrations up to 2500 µg/plate.

Executive summary:

Chloroacetamide solved in DMSO was tested in a Bacterial Reverse Mutation Assay with Salmonella typhimurium TA 98, TA100, TA1535 and TA1537, with and without metabolic activation (S9) at conentrations of 4 to 2500 µg/plate. The plates were incubated for 48 hours at 37°C and then the numbers of reverted bacterial colonies counted.There was no mutagenicity neither in the presence nor absence of rat liver preparation up to 2500 µg/plate.