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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Not specified; published in 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guidelines followed, very limited information provided, no positive controls included.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Treatments with bacteria were performed at a cell density of approximately 3x10E9 cells/ml, at 25°C for 1 hour.
Incubation was terminated by centrifugation and resuspending bacteria in fresh buffer.
Bacteria were then plated with the soft agar technique.
Incubation and scoring as described in another publication (Rannug et al, 1974).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): chloroacetic acid
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Target gene:
histidine
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535
Metabolic activation:
without
Test concentrations with justification for top dose:
0.1, 0.5 and 1.5 mM. Each concentration was tested using 5 plates.
Vehicle / solvent:
water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
water
True negative controls:
no
Positive controls:
no
Positive control substance:
no
Details on test system and experimental conditions:
METHOD OF APPLICATION: ipre-incubation

DURATION
- Preincubation: 1 hour

NUMBER OF REPLICATIONS: 5 per concentration

NUMBER OF CELLS EVALUATED: 10E8 per plate

DETERMINATION OF CYTOTOXICITY
- Method: performed, but not described according to which method.
Evaluation criteria:
No data
Statistics:
Students' t-test

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
not applicable

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Chloroacetic acid did not induce the number of mutants in the absence of S9-mix at concentrations up to 1.5 mM.