Propargite

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:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Propargite

EC Number:

219-006-1

EC Name:

Propargite

Cas Number:

2312-35-8

Molecular formula:

C19H26O4S

IUPAC Name:

propargite

Test material form:

liquid

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

Saccharomyces cerevisiae

Details on mammalian cell type (if applicable):

Strain: D4

Metabolic activation:

with and without

Test concentrations with justification for top dose:

0, 0.001, 0.01, 0.1, 1.0 and 5.0 µL/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: deionised water or DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

2-nitrofluorene

other: methylnitrosoguanidine, quinacrine mustard, 2-anthramine, 8-aminoquinoline

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation). Direct to molten agar mixture containing biotin and histidine, plus 0.5 mL activated S-9 liver homogenate reaction mixture in the case of metabolic activation, and then final agar mixture poured into plates.

NUMBER OF REPLICATIONS: One

DURATION
- Exposure duration: 48 hours at 37 ºC

Results and discussion

Test results

Test results 1

Key result

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:

not specified

Remarks:

yes

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

Saccharomyces cerevisiae

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Table 1: Summary of plate test results

	Revertants per plate
	TA 1535	TA 1537	TA 1538	TA 98	TA 100	D4
Non-activation
Solvent control	21	10	16	27	154	29
Positive control*	>1000	968	729	>1000	467	288
0.001 UL test material	22	16	11	22	171	23
0.01 UL test material	15	14	12	36	149	19
0.1 UL test material	28	3	9	25	136	22
1.0 UL test material	18	11	8	36	171	17
5.0 UL test material	13	5	17	45	140	26
Activation
Solvent control	22	13	20	46	141	20
Positive control**	254	299	682	436	465	20
0.001 UL test material	18	9	15	48	68	16
0.01 UL test material	14	15	18	32	153	16
0.1 UL test material	8	6	10	36	92	17
1.0 UL test material	17	13	3	38	102	15
5.0 UL test material	25	17	6	22	146	16

*TA 1535: Methylnitrosoguanidine TA 1537: Quinaracene mustard TA 1538: 2-nitrofluorene TA 98: 2-nitrofluorene TA 100: Methylnitrosoguanidine D4: Methylnitrosoguanidine **TA 1535: 2-anthramine TA 1537: 8-aminoquinoline TA 1538: 2-acetylaminofluorene TA 98: 2-acetlyaminofluorene TA 100: 2-anthramine D4: 2-anthramine  

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

Under the conditions of the test, the test material was determined to be negative for genotoxicity in a bacterial reverse mutation assay.

Executive summary:

In a non-GLP bacterial reverse mutation assay conducted in accordance with a procedure considered to be similar or equivalent to EU Method B.14, the genotoxicity of the test material was determined. Under the conditions of the test, the test substance was determined to be negative for genotoxicity.