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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
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 resultsopen allclose all
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
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
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.

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