Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

Genetic toxicity: in vitro

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:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

EC Number:

283-392-8

EC Name:

Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

Cas Number:

84605-29-8

Molecular formula:

Not applicable

IUPAC Name:

Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

Method

Target gene:

Histidine operon (hisG46, hisC3076, hisD3052); Lipopolysaccharide barrier (LPA); DNA excision repar (uvrB)

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

mammalian microsomal enzymes

Test concentrations with justification for top dose:

with s9 mix; 25, 50, 100, 250, 1000, and 5000 ug/plate
without s9 mix: 10, 25, 50, 120, 600, and 3000 ug/plate
Confirmatory assay:
with s9 mix: 100, 250, 500, 1000, 2500 and 5000 ug/plate
without s9 mix: 50, 100, 250, 500, 1000 and 3000 ug/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle:

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: multiple postive controls (depedning on strain and metabolic activation)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Preincubation period:
- Exposure duration: 48 hours
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):


SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):


NUMBER OF REPLICATIONS:


NUMBER OF CELLS EVALUATED:


DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition


OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:


OTHER:

Evaluation criteria:

TA98, TA100, WP2uvrA: A postive result must produce at least a 2-fold increase the mean revertants per plate of at least one tester strain over the mean revertants per plate fo the control. A dose response in the mean number of revertants per plate must also occur.
TA1535 and TA1537: A postive result must produce at least a 3-fold increase the mean revertants per plate of at least one tester strain over the mean revertants per plate fo the control. A dose response in the mean number of revertants per plate must also occur.

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:

valid

Positive controls validity:

valid

Additional information on results:

Test article precipitate was observed on the plates at doses equal to or greater than 3000 ug/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation