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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Key: Thompson et. al. (1983), Genetic toxicity in vitro - Bacterial Reverse Mutation test: Negative. 

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
This study was not conducted in a GLP facility, but was conducted equivalent to OECD Guideline 471 "Bacterial Reverse Mutation Test".
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine auxotroph
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
other: histidine auxotroph
Species / strain / cell type:
E. coli WP2
Additional strain / cell type characteristics:
other: tryptophan auxotroph
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
other: tryptophan auxotroph
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S-9
Test concentrations with justification for top dose:
The study was conducted up to a maximum concentration of 1,000 ug/mL agar.
Vehicle / solvent:
All dilutions were made using reagent-grade dimethyl sulfoxide (DMSO), and a final concentration of 1 % DMSO did not influence toxicity or the genetic endpoints of the test.
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
2-acetylaminofluorene
Remarks:
Migrated to IUCLID6: and Streptozotocin
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:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Conclusions:
Interpretation of results:
negative with and without metabolic activation

The test item exhibited no evidence of inducing bacterial mutation to the strains of bacteria tested in this study, both with and without metabolic activation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

One Key study, the in vitro bacterial reverse mutation test was available (Thompson et. al., 1983).


The study was determined to be a Klimisch 2 score, and outcome was negative. As such, no further testing wass required under the testing strategy for Mutagenicity. The substance is therefore not classified for genetic toxicity according to CLP Regulation (EC) No 1272/2008.