Orthosulfamuron

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Directive 92/69/EEC (July 31, 1992) Council Directive 67/548/EEC, Method B.13 and B.14 MAFF 59 Nohsan No. 4200 (January 28, 1985)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial forward mutation assay

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Test material:
IR5878
Batch number: FCF/T/159-99 (ex 20274/71)
Purity: 93.72 ± 1.05 %

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Test concentrations with justification for top dose:

In the preliminary toxicity test performed as part of the first experiment (plate incorporation assay) inhibition of growth of all the Salmonella typhimurium strains but not of Escherichia coli was observed at 6 out of the 7 concentrations tested (5, 15, 50, 150, 500, 1500, 5000 µg/plate, spaced approximately half-log).
A second experiment was therefore repeated on Salmonella typhimurium strains at lower concentrations (0.05, 0.15, 0.5, 1.5, 5 µg/plate).
A third experiment concluded the study, using both the Salmonella typhimurium strains and Escherichia coli, following the pre-incubation method with metabolic activation and the plate test method without metabolic activation (concentrations of 0.05, 0.15, 0.5, 1.5, 5 µg/plate).

Vehicle / solvent:

Negative control (vehicle): dimethyl sulfoxide

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

other:

Details on test system and experimental conditions:

Test material:
IR5878
Batch number: FCF/T/159-99 (ex 20274/71)
Purity: 93.72 ± 1.05 %

Test systems:
Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100
Escherichia coli strain WP2 uvrA

Control articles:
Negative control (vehicle): dimethyl sulfoxide
Positive controls in the test without metabolic activation:
Salmonella typhimurium strains TA 1535: hydrazine sulfate
Salmonella typhimurium strains TA 1537: 9-aminoacridine HCl monohydrate
Salmonella typhimurium strains TA 98 and TA 100: doxorubicine HCl
Escherichia coli strain WP2 uvrA: methyl methane-sulfonate
Positive controls in the test with metabolic activation:
Salmonella typhimurium strains TA 1535 and TA 1537: 2-aminoanthracene
Salmonella typhimurium strains TA 98 and TA 100: 2-aminofluorene
Escherichia coli strain WP2 uvrA-: 2-aminoanthracene

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

positive

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

positive

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

positive

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

In the preliminary toxicity test performed as part of the first experiment (plate incorporation assay) inhibition of growth of all the Salmonella typhimurium strains but not of Escherichia coli was observed at 6 out of the 7 concentrations tested (5, 15, 50, 150, 500, 1500, 5000 µg/plate, spaced approximately half-log). A second experiment was therefore repeated on Salmonella typhimurium strains at lower concentrations (0.05, 0.15, 0.5, 1.5, 5 µg/plate). A third experiment concluded the study, using both the Salmonella typhimurium strains and Escherichia coli, following the pre-incubation method with metabolic activation and the plate test method without metabolic activation (concentrations of 0.05, 0.15, 0.5, 1.5, 5 µg/plate).

Remarks on result:

mutagenic potential (based on QSAR/QSPR prediction)

Any other information on results incl. tables

In the preliminary toxicity test performed as part of the first experiment (plate incorporation assay) inhibition of growth of all theSalmonella typhimuriumstrains but not ofEscherichia coliwas observedout of the 7 concentrations tested (5, 15, 50, 150, 500, 1500, 5000 µg/plate, spaced approximately half-log). A second experiment was therefore repeated onSalmonella typhimuriumstrains at lower concentrations (0.05,0.5, 1.5, 5 µg/plate). A third experiment concluded the study, using both theSalmonella typhimuriumstrains andEscherichia coli, following the pre-incubation method with metabolic activation and the plate test method without metabolic activation (concentrations of0.15, 0.5, 1.5, 5 µg/plate).

Applicant's summary and conclusion

Conclusions:

IR5878 was not mutagenic either in absence or in presence of metabolic activation, up to the concentration of 5 μg/plate when tested on Salmonella typhimurium TA 1535, TA 1537, TA 98, and TA 100 or up to the concentration of 5000 μg/plate when tested on Escherichia coli WP2 uvrA- strain according to Ames.

Executive summary:

In the preliminary toxicity test performed as part of the first experiment (plate incorporation assay) inhibition of growth of all the Salmonella typhimurium strains but not of Escherichia coli was observedout of the 7 concentrations tested (5, 15, 50, 150, 500, 1500, 5000 µg/plate, spaced approximately half-log). A second experiment was therefore repeated on Salmonella typhimurium strains at lower concentrations (0.05,0.5, 1.5, 5 µg/plate). A third experiment concluded the study, using both the Salmonella typhimurium strains and Escherichia coli, following the pre-incubation method with metabolic activation and the plate test method without metabolic activation (concentrations of0.15, 0.5, 1.5, 5 µg/plate).