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EC number: 255-255-2 | CAS number: 41198-08-7
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
- Study period:
- 13 November 1990 to 11 January 1991
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MHW Japan Part 1, notification no 118
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- EC Number:
- 255-255-2
- EC Name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- Cas Number:
- 41198-08-7
- Molecular formula:
- C11H15BrClO3PS
- IUPAC Name:
- 4-bromo-2-chlorophenyl ethyl (propylsulfanyl)phosphonate
- Test material form:
- liquid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced
- Test concentrations with justification for top dose:
- Toxicity test: 0, 20.6, 61.7, 185.2, 555.6, 1666.7, 5000 ug/mL Mutation assay: 0, 312.5, 625, 1250, 2500, 5000 ug/mL
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO for all strains
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: 5 ug/plate. TA100; TA1535
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Migrated to IUCLID6: 2 ug/plate. E coli
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- -S9Migrated to IUCLID6: 20 ug/plate. TA98
- Positive controls:
- yes
- Remarks:
- -S9
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: 150 ug/plate. TA1537
- Positive controls:
- yes
- Remarks:
- +S9
- Positive control substance:
- other: 2-aminoanthracene. 2.5 ug/plate (TA100; TA98; TA1537) or 50 ug/plate (E coli)
- Positive controls:
- yes
- Remarks:
- +S9
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: 400 ug/plate. TA1535
Results and discussion
Test resultsopen allclose all
- 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
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
INITIAL TOXICITY-MUTATION ASSAY:
Six doses of the test material ranging from 20.6 to 5000 ug/plate±S9 were evaluated in the overlay toxicity test using T100 WP2urA strains. No precipitation was observed up to the limit dose, 5000 ug/plate. Based on the qualitative data generated, cytotoxicity (as indicated by decreased revertants/plate) was evident at the highest dose tested (HDT) with most test conditions. Hence, 5000 ug/plate (the maximum recommended dose in accordance with guidelines) ± S9 was chosen as the HDT for mutagenicity testing using the overlay method.
CONFIRMATORY MUTAGENICITY ASSAY:
Reproducible cytotoxic effects were seen in the confirmatory mutation test in the majority of strains at 5000 mg/plate±S9. Revertant counts in profenofos treated pre-incubation tests did not differ from the negative (DMSO) control data.Owing to a growth-inhibiting effect of the test material in experiments without and with S9 activation, a reduction in the colony numbers by more than 50% was occasionally observed with strains TA1537 and WP2uvrA at the upper concentrations. No precipitate was observed. In contrast, positive controls responded appropriately with at least a three-fold increase in the number of revertants over the mean value of the respective vehicle control.
Table 7.6.1 -1: Bacterial mutation assay, summary of results
Dose (ug/plate) |
0 |
312.5 |
625 |
1250 |
2500 |
5000 |
Positive control |
REVERTANTS/PLATE ± STANDARD DEVIATION |
|||||||
INITIAL MUTATION ASSAY |
|||||||
TA98 -S9 |
24.7±6.1 |
19.7±6.1 |
10.7±6.4 |
16.3±0.6 |
19.3±7.5 |
15.3±3.5 |
616.3±68.3 |
TA98 +S9 |
31.0±8.7 |
21.7±7.0 |
24.7±7.0 |
22.3±8.7 |
22.0±6.2 |
20.0±3.5 |
1582.0±92.5 |
TA100 -S9 |
111.7±1.5 |
104.7±19.5 |
113.3±5.9 |
106.7±12.2 |
112.0±9.2 |
109.3±10.5 |
757.3±78.5 |
TA100 +S9 |
118.0±14.5 |
104.7±7.2 |
101.0±9.0 |
100.7±23.1 |
117.3±8.5 |
119.0±5.0 |
1266.0±412.0 |
TA1535 -S9 |
10.3±3.8 |
14.7±0.6 |
14.7±0.6 |
12.3±3.5 |
11.3. ±3.1 |
13.7±2.1 |
558.3±49.6 |
TA1535 +S9 |
9.7±2.1 |
11.0±4.6 |
7.3±4.5 |
6.0±2.6 |
4.3±3.2 |
8.7±2.3 |
213.3±9.1 |
TA1537 -S9 |
8.7±1.5 |
4.7±2.1 |
5.3±0.6 |
3.3±1.5 |
4.3±1.2 |
3.3±0.6 |
1465.0±229.4 |
TA1537 +S9 |
5.3±2.9 |
3.7±0.6 |
6.7±1.5 |
6.7±1.5 |
2.3±1.2 |
1.7±1.5 |
98.7±12.1 |
WP2uvrA –S9 |
22.3±3.8 |
19.0±1.0 |
17.3±3.1 |
21.7±5.9 |
16.0±4.4 |
18.0±6.0 |
837.7±169.2 |
WP2uvrA +S9 |
28.3±10.1 |
22.0±3.6 |
22.7±3.2 |
14.7±2.5 |
24.3±6.5 |
10.0±2.0 |
1233.7±149.9 |
CONFIRMATORY ASSAY |
|||||||
TA98 -S9 |
36.0±3.6 |
26.7±2.5 |
28.0±4.4 |
42.7±4.6 |
23.7±5.5 |
34.3±2.3 |
850.7±57.7 |
TA98 +S9 |
46.0±3.6 |
40.0±12.5 |
46.3±5.5 |
28.0±3.5 |
37.7±5.1 |
24.0±5.0 |
2590.3±319.9 |
TA100 -S9 |
81.0±4.0 |
77.7±26.3 |
81.7±3.5 |
96.0±8.2 |
92.7±11.0 |
87.3±20.6 |
373.0±24.3 |
TA100 +S9 |
93.3±10.8 |
83.3±18.1 |
77.3±9.7 |
80.3±10.8 |
5.7±1.2 |
53.3±2.9 |
1678.7±56.1 |
TA1535 -S9 |
19.3±2.1 |
16.7±2.1 |
21.0±4.4 |
20.3±4.0 |
19.0±2.6 |
14.0±2.6 |
1337.7±67.3 |
TA1535 +S9 |
10.3±4.7 |
11. 3±4.7 |
12.7±0.6 |
12.7±5.9 |
14.3±0.6 |
9.0±5.3 |
335.3±10.0 |
TA1537 -S9 |
4.7±2.1 |
7.5±0.7 |
6.7±0.6 |
5.7±0.3 |
3.0±1.0 |
3.0±2.0 |
1454.0±234.2 |
TA1537 +S9 |
11.0±5.3 |
7.7±1.5 |
10.0±4.6 |
7.7±1.5 |
4.7±2.1 |
4.7±0.6 |
81.3±11.2 |
WP2uvrA –S9 |
37.3±4.2 |
37.0±1.0 |
36.0±5.6 |
27.0±8.2 |
24.0±4.4 |
17.0±3.6 |
1507.0±103.6 |
WP2uvrA +S9 |
48.7±3.5 |
45.0±7.8 |
38.0±7.2 |
30.7±5.7 |
16.3±3.8 |
12.0±7.8 |
1728.7±103.1 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):negative with metabolic activationnegative without metabolic activationBased on the results from this study, profenofos was not mutagenic in the bacterial strains tested, either in the presence or absence of metabolic activation when tested up 5000 mg/plate (the maximum dose in accordance with regulatory guidelines).
- Executive summary:
In a reverse gene mutation assay in bacteria,Salmonella typhimurium strains TA98, TA100, TA1535, and TA1537 and Escherichia coli strain WP2uvrA were exposed to CGA15324 tech formulated in DMSO. The assay was performed in two phases, using the plate incorporation method.
Following a preliminary toxicity-mutation assay, dose levels of 312, 625, 1250, 2500 and 5000 ug/plate in the presence and absence of S9 activation were assessed in an initial and confirmatory mutagenicity assay. Owing to a growth-inhibiting effect of the test material in experiments without and with S9 activation, a reduction in the colony numbers by more than 50% was occasionally observed with strains TA1537 and WP2uvrA at the upper concentrations. No precipitate was observed.
Based on the results from this study, profenofos was not mutagenic in the bacterial strains tested, either in the presence or absence of metabolic activation when tested up 5000 ug/plate (the maximum dose in accordance with regulatory guidelines).
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