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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP compliance

Data source

Reference
Reference Type:
publication
Title:
Salmonella mutagenicity tests
Author:
Mortelmans, Haworth, Lawlor, Speck, Tainer, Zeiger
Year:
1986
Bibliographic source:
Environ. Mutagen. 8, Suppl 7: 1-119

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Vendor purity: 99.6%
Analytical purity: 99%

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
- Type and identity of media: Oxoid Nutrient Broth
- Properly maintained: No data
- Periodically checked for Mycoplasma contamination: No data
- Periodically checked for karyotype stability: No data
- Periodically "cleansed" against high spontaneous background: No data
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat and hamster S9
Test concentrations with justification for top dose:
In the absence of S9 mix: 10-1000 µg/plate
In the presence of S9 mix: 100-3333 µg/plate
Vehicle / solvent:
H2O
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
H2O
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
without S9 mix Migrated to IUCLID6: for TA1535 and TA100
Untreated negative controls:
yes
Remarks:
H2O
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene for all tester strains
Remarks:
with S9 mix
Untreated negative controls:
yes
Remarks:
H2O
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S9 mix Migrated to IUCLID6: for TA1535
Untreated negative controls:
yes
Remarks:
H2O
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-pheylenediamine for TA98
Remarks:
without S9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

SELECTION AGENT (mutation assays): Histidine

NUMBER OF REPLICATIONS: No data

DETERMINATION OF CYTOTOXICITY
- Method: the reduction of the bacterial background lawn, the availability of pinpoint colonies and the reduction of the revertant colonies
Evaluation criteria:
Mutagenic response:
Dose related, reproducable increase in the number of revertants over background, even if the increase was less than twofold
Nonmutagenic response:
When no increase in the number of revertants was elicited by the chemical
Questionable response:
When there was an absence of a clear-cut dose related increase in revertants, when the dose related increases in the number of revertants were not reproducible or when the response was of insufficient magnitude to support a determination of mutagenicity.
Statistics:
Not applicable

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:
cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Chloroacetic acid showed toxicity in the absence of S9 mix in tester strain TA1535 at concentrations of 333 and 1000 µg/plate resulting in a decrease in the number of revertants. In the presence of S9 mix a slight reduction of the background lawn was observed in tester strains TA100 and TA1537 (both hamster and liver S9 mix) and in tester strain TA1535 (hamster S9 mix). A reduction in the number of revertants was observed at a concentration of 3333 µg/plate in tester strain TA100 and at concentrations of 2000 and 3333 in tester strains TA1535, TA1537 and TA98.

Applicant's summary and conclusion

Conclusions:
Chloroacetic acid was not mutagenic in the Salmonella mutagenicity test.