Bromacil

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

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:

September 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Purity: 95%

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain / cell type:

S. typhimurium TA 97

Species / strain / cell type:

S. typhimurium TA 98

Species / strain / cell type:

S. typhimurium TA 100

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

0, 10, 50, 100, 500, 1000 and 5000 µg/plate

Vehicle / solvent:

dimethylsulfoxide (DMSO)

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

other: 2-aminoanthracene, 2-nitrofluorene, Acridine

Details on test system and experimental conditions:

Treatments without activation (nonactivated) were conducted by adding 0.1 mL of the solvent or a solution of Bromacil and 0.1 mL of an overnight culture containing approximately 10^8 bacteria to 2 mL of top agar (0.6% agar, 0.6% NaCl, 0.05 mM L-histidine, 0.05 mM biotin). These components were mixed and poured on the surface of a plate containing 25 mL of Davis minimal agar.
Treatments with activation were conducted by adding 0.5 mL of S-9 mix to the bacteria/test sample/top agar as described above and pouring the mixture onto a minimal agar plate.

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 97

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

Bromacil was tested for mutagenic activity in Salmonella typhimurium strains TA1535, TA97, TA98 and TA100 in the presence and absence of an activation system. Under the conditions of this assay, Bromacil is negative.

Executive summary:

Bromacil was tested for cytotoxicity in Salmonella typhimurium strain TA98 with and without activation. Bromacil exhibited toxicity to strain TA98 without and with activation at levels of 5000 ug/plate. Based on these results, 5000 ug/plate without and with activation was chosen as the highest dose for the mutagenicity assays.

Bromacil was tested for mutagenic activity in Salmonella typhimurium strains TA1535, TA97, TA98 and TA100 with and without activation. No mutagenic activity was detected in any strain either without or with activation at levels up to 5000 ug/plate. Under the conditions of this assay, Bromacil is negative.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

Bromacil was tested for mutagenic activity in Salmonella typhimurium strains TA1535, TA97, TA98 and TA100 with and without activation. No mutagenic activity was detected in any strain either without or with activation at levels up to 5000 ug/plate. Under the conditions of this assay, Bromacil is negative.