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Diss Factsheets

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:
1980-09-25 to 1981-08-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar go guideline and under GLP with minor restrictions. Only tested to 2500 µg/plate and no cross-linking sensitive tester strain used (e.g. TA102 or E.coli WP2)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
no cross-linking sensitive tester strain used (e.g. TA102 or E.coli WP2)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate
EC Number:
932-389-6
Molecular formula:
C23H19ClF3NO3
IUPAC Name:
Reaction mass of (R)-cyano(3-phenoxyphenyl)methyl rel-(1R,3R)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate and (R)-cyano(3-phenoxyphenyl)methyl rel-(1S,3S)-3-((1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl)-2,2-dimethylcyclopropanecarboxylate

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
Metabolic activation:
with
Metabolic activation system:
S9 mix from Aroclor1254 induced rat liver
Test concentrations with justification for top dose:
4, 20, 100, 500, 2500 µg/plate
Vehicle / solvent:
- Vehicle/solvent used: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene, N-Methyl-N'-nitro-N-nitrosoguanidine, 9-Aminoacridine, 4-Nitroquinoline N-oxide
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 3-4 d

NUMBER OF REPLICATIONS: 3 plates per dose
Evaluation criteria:
A positive response was taken to be a two-fold or greater increase in the mean number of revertant colonies appearing over background reversion rate together with evidence of a dose response.
Statistics:
Mean and standard deviation of three plates per dose group were determined.

Results and discussion

Test results
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
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: observed at 2500 µg/plate in test No. 2

Any other information on results incl. tables

Table: Results of the Ames test with Cyhalothrin

Strain

S9

Concentration [µg/plate]

Test 1

 

Test 2

 

Mean ± SD

Ratio

Mean ± SD

Ratio

TA1535

+

Solvent control

25.2±5.7

 

31.4±6.1

 

2500

14.7±4.6

0.6

24.7±4.6

0.8

500

14.3±4.7

0.6

23.7±5.5

0.8

100

15.3±2.9

0.6

24.3±4.9

0.8

20

19.3±3.2

0.8

28.7±3.2

0.9

4

18.0±6.7

0.7

31.3±0.6

1.0

TA1535

-

Solvent control

43.6±3.5

 

17.6±6.3

 

2500

42.3±9.7

1.0

127.3±129.5

7.2

500

40.7±7.8

0.9

16.7±7.4

0.9

100

48.3±12.1

1.1

22.0±5.2

1.3

20

51.0±12.0

1.2

23.7±8.5

1.3

4

49.3±17.4

1.1

18.7±4.2

1.1

TA1537

+

Solvent control

35.8±5.8

 

23.4±4.0

 

2500

19.3±2.5

0.5

22.7±1.2

1.0

500

21.3±3.1

0.6

20.5±8.7

0.9

100

29.0±6.1

0.8

22.3±4.0

1.0

20

24.0±3.6

0.7

21.0±7.5

0.9

4

28.0±3.6

0.8

21.0±3.0

0.9

TA1537

-

Solvent control

14.8±3.9

 

13.0±2.2

 

2500

10.3±4.5

0.7

10.7±2.9

0.8

500

16.0±5.0

1.1

13.0±3.0

1.0

100

19.3±4.5

1.3

16.0±4.0

1.2

20

12.3±1.2

0.8

12.3±4.0

0.9

4

11.7±4.0

0.8

14.3±2.9

1.1

TA1538

+

Solvent control

58.8±14.1

 

47.4±5.1

 

2500

35.3±2.1

0.6

26.3±10.5

0.6

500

48.7±9.0

0.8

39.0±5.7

0.8

100

56.7±0.6

1.0

62.0±4.0

1.3

20

63.0±9.6

1.1

61.3±5.5

1.3

4

52.3±17.6

0.9

51.0±14.9

1.1

TA1538

-

Solvent control

32.8±1.3

 

15.6±5.0

 

2500

19.0±4.6

0.6

14.0±6.1

0.9

500

25.7±14.6

0.8

13.7±1.2

0.9

100

16.0±7.2

0.5

27.0±18.4

1.7

20

19.0±5.6

0.6

14.3±7.8

0.9

4

27.7±1.2

0.8

22.3±5.0

1.4

TA98

+

Solvent control

50.0±6.7

 

47.0±7.3

 

2500

38.3±5.0

0.8

51.5±6.4

1.1

500

44.0±3.0

0.9

49.3±12.2

1.0

100

42.0±1.7

0.8

48.3±1.2

1.0

20

46.3±10.8

0.9

54.0±2.6

1.1

4

43.7±7.6

0.9

50.7±9.5

1.1

TA98

-

Solvent control

31.8±4.7

 

23.8±5.1

 

2500

20.8±6.9

0.6

29.3±9.0

1.2

500

22.7±4.5

0.7

31.0±10.8

1.3

100

26.3±6.8

0.8

29.3±2.1

1.2

20

19.0±4.4

0.6

29.0±1.0

1.2

4

24.0±1.7

0.8

22.7±4.0

1.0

TA100

+

Solvent control

140.8±9.9

 

195.8±16.4

 

2500

120.0±15.5

0.9

189.7±2.5

1.0

500

125.3±23.9

0.9

176.3±24.0

0.9

100

116.3±15.3

0.8

182.3±16.6

0.9

20

135.3±11.0

1.0

188.5±20.5

0.9

4

113.3±10.7

0.8

171.7±20.4

0.9

TA100

-

Solvent control

116.8±15.4

 

96.8±12.5

 

2500

74.7±6.4

0.6

107.3±15.0

1.1

500

104.3±14.6

0.9

120.0±19.7

1.2

100

85.0±10.4

0.7

107.7±11.6

1.1

20

97.0±11.0

0.8

105.0±18.5

1.1

4

79.0±14.7

0.7

98.3±16.4

1.0

 

Applicant's summary and conclusion

Conclusions:
The test item Cyhalothrin was found to be not mutagenic in the bacterial reverse mutation assay (Ames test) with the tester strains TA1535, TA1537, TA1538, TA98, and TA100 with or without metabolic activation using S9 mix from Aroclor1254 induced rat liver.
Executive summary:

The mutagenic potential of Cyhalothrin was assessed in a bacterial reverse mutation assay (Ames test). The test was performed similar to OECD Guideline 471 using Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98, and TA100. Deviation from the actual guideline was the lack of cross-linking tester strains such as TA102 or E. coli WP2 and only tested to 2500 µg/plate. GLP compliance was stated.

The test item Cyhalothrin was found to be not mutagenic in the bacterial reverse mutation assay (Ames test) with the tester strains TA1535, TA1537, TA1538, TA98, and TA100 with or without metabolic activation using S9 mix from Aroclor1254 induced rat liver.