Reaction product of propargyl chloride and sodium bisulfite

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:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1992

Deviations:

yes

Remarks:

E.coli not tested

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

E.coli not tested

GLP compliance:

yes

Remarks:

BASF SE, Department of Toxicology, 67056 Ludwigshafen, Germany

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: liquid

Details on test material:

Name of the test substance used in the study report: Golpanol PS
Purity: 15.2%

Specific details on test material used for the study:

new name: Reaction product of propargyl chloride and sodium bisulfite
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Abl.-Nr. 79-0065

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Method

Target gene:

histidine

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: all strains show a considerably reduced hydrophilic polysaccharide layer (rfa), which leads to an increase in permeability to lipophilic substances

Metabolic activation:

with and without

Metabolic activation system:

Aroclor induced rat liver S9-mix

Test concentrations with justification for top dose:

1st Experiment: standard plate test with and without S9-mix
Doses: 0, 2500, 5000, 10000, 15000 and 20000 µg/pIate

2nd Experiment: preincubation test with and without S9-mix
Doses: 0, 2500, 5000, 10000, 15000 and 20000 µg/plate

Vehicle / solvent:

Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (with S9-mix, TA 100, TA 98, TA 1537, TA 1535); N-methyl-N´-nitro-N-nitrosoguanidine (without S9-mix; TA 100 and TA 1535), 4-nitro-o-phenylendiamine (without S9-mix; TA 98), 9-aminoacridine chloride monohydrate (without S9-miix; TA 1537)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 0.1 mL test solution or solvent, 0.1 mL bacterial suspension and 0.5 mL S9-mix are incubated at 37°C
- Exposure duration: 20 min
- Expression time (cells in growth medium): 48 hours on agar plates at 37°C in the dark

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: No bacteriotoxic effect was observed.

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:

negative

Cytotoxicity / choice of top concentrations:

other: No bacteriotoxic effect was observed.

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:

negative

Cytotoxicity / choice of top concentrations:

other: No bacteriotoxic effect was observed.

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:

negative

Cytotoxicity / choice of top concentrations:

other: No bacteriotoxic effect was observed.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: Complete solubility of the test substance in aqua dest.