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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: Procarbazine-HCl
Remarks:
without S9
Positive controls:
yes
Positive control substance:
other: Streptozotocin
Remarks:
without S9
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S9
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.

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