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Toxicological information

Genetic toxicity: in vitro

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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:
June 13, 1997 to August 08, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: S. typhimurium, other: TA1535, TA1537, TA98, TA100, and TA102
Metabolic activation:
with and without
Metabolic activation system:
Rat Liver S9-Mix
Test concentrations with justification for top dose:
1st series: 5, 15.8, 50, 158, 500, 1580, and 5000 µg/plate
2nd series: 50, 158, 500, 1580, and 5000 µg/plate
Vehicle / solvent:
DMSO or acetone and ethanol
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
Aqua bidest (H2O)
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Daunomycin, N-ethyl-N'-nitro-N-nitrosoguanidine, 9-aminoacridine, Cumene hydroperoixide, 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 37 degrees C for days
Evaluation criteria:
Dose-related response with significant increase over negative controls. Test is valid if there is a significant increase in mutation frequency in positive controls as compared to negative controls.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
not determined
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Any other information on results incl. tables

Results for Experiment I (Mean Revertants/plate (SD)) – Without S9

 

Strain

S9 Mix

TA98

TA100

TA102

TA1535

TA1537

WP2

Solvent

-

16 (2)

99 (9)

218 (19)

9 (3)

5 (3)

82 (16)

5

-

5 (3)

117 (22)

233 (16)

13 (3)

8 (3)

99 (3)

15.8

-

7 (3)

114 (7)

215 (25)

7 (2)

5 (2)

91 (6)

50

-

7 (2)

99 (10)

242 (12)

11 (3)

6 (3)

95 (4)

158

-

6 (3)

104 (3)

233 (10)

10 (3)

5 (1)

87 (15)

500

-

6 (2)

94 (15)

219 (14)

10 (3)

7 (1)

73 (18)

1580

-

12 (5)

102 (34)

231 (42)

10 (1)

7 (4)

76 (10)

5000

-

11 (3)

112 (10)

215 (11)

6 (2)

7 (3)

82 (12)

 

Results for Experiment I (Mean Revertants/plate (SD)) – With S9

 

Strain

S9 Mix

TA98

TA100

TA102

TA1535

TA1537

WP2

Solvent

+

18 (4)

116 (16)

309 (12)

11 (6)

6 (1)

86 (13)

5

+

14 (1)

127 (18)

283 (3)

13 (3)

5 (2)

116 (9)

15.8

+

14 (4)

128 (18)

294 (5)

9 (2)

6 (3)

88 (10)

50

+

15 (3)

127 (8)

288 (16)

12 (5)

6 (2)

102 (15)

158

+

16 (1)

128 (7)

293 (29)

12 (3)

4 (2)

103 (20)

500

+

20 (1)

118 (6)

287 (6)

15 (5)

5 (2)

106 (7)

1580

+

14 (1)

118 (3)

297 (14)

13 (2)

8 (1)

104 (19)

5000

+

15 (5)

116 (38)

280 (22)

12 (5)

8 (2)

112 (19)

 

Results for Experiment II (Mean Revertants/plate (SD)) – Without S9

 

Strain

S9 Mix

TA98

TA100

TA102

TA1535

TA1537

WP2

Solvent

-

16 (3)

84 (9)

208 (36)

7 (3)

6 (1)

82 (5)

50

-

12 (3)

82 (9)

163 (2)

8 (3)

3 (2)

92 (6)

158

-

13 (3)

84 (11)

182 (12)

7 (4)

4 (1)

92 (5)

500

-

13 (2)

86 (13)

177 (26)

6 (3)

4 (3)

76 (4)

1580

-

8 (2)

93 (17)

202 (6)

6 (4)

2 (1)

81 (9)

5000

-

8 (3)

89 (5)

185 (11)

5 (3)

4 (2)

90 (5)

 

Results for Experiment II (Mean Revertants/plate (SD)) – With S9

 

Strain

S9 Mix

TA98

TA100

TA102

TA1535

TA1537

WP2

Solvent

+

20 (3)

115 (7)

209 (32)

10 (3)

6 (1)

99 (12)

50

+

22 (4)

112 (5)

182 (16)

10 (2)

8 (1)

97 (16)

158

+

15 (4)

107 (5)

197 (14)

10 (2)

10 (3)

102 (5)

500

+

20 (2)

121 (15)

201 (3)

9 (3)

6 (2)

108 (16)

1580

+

21 (7)

105 (13)

195 (7)

9 (7)

8 (1)

101 (3)

5000

+

17 (1)

109 (5)

184 (13)

10 (1)

6 (1)

85 (10)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance is not mutagenic in either the presence or absence of metabolic activation.
Executive summary:

This study examined the mutagenic potential of the test substance. Salmonella typhimuirum strains TA1537, TA1535, TA102, TA98, and TA100, were exposed to concentrations ranging from 5 to 5000 ug/plate of test substance in DMSO (or other organic solvent) in both the presence and absence of S9. Positive control substances were Daunomycin, N-ethyl-N'-nitro-N-nitrosoguanidine, 9 -aminoacridine and cumene hydroperoxide. Cultures were tested in triplicate for mutation frequency. No treatment cultures showed mutation frequencies significantly greater than negative controls. Positive controls showed significantly greater mutation frequencies over negative controls, therefore the test was valid. The test substance is not mutagenic in either the presence or absence of metabolic activation.