Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(strain with AT base pair at the primary reversion site is missing)

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)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)

EC Number:

224-235-5

EC Name:

Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)

Cas Number:

4259-15-8

Molecular formula:

Too complex

IUPAC Name:

1-Hexanol, 2-ethyl-, O,O-diester with phosphorodithioic acid, zinc salt

Method

Target gene:

Histidine operon (hisG46, hisC3076, hisD3052); Lipopolysaccharide barrier (LPA); DNA excision repair (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 µg/plate
without S9 mix: 1, 5, 10, 25, 100, 500 µg/plate
Confirmatory assay:
with S9 mix; 50, 100, 250, 500, 1000, and 5000 µg/plate
without S9 mix: 5, 10, 25, 50, 100, 500 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

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

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition

Evaluation criteria:

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

Results and discussion

Test results

Key result

Species / strain:

other: 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

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The test substance did not show mutagenic properties in TA98, TA100, TA1535 and TA1537 with and without metabolic activation.