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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with minor deviations. (No E.coli strains were tested.)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
No E.coli strains were tested.
Qualifier:
according to
Guideline:
EPA OPP 84-2
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ziram technical
- Lot no.: 8331 AA
- Purity: 98.5%

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA 1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from Aroclor-induced rat livers
Test concentrations with justification for top dose:
100, 50, 15, 5, 1.5, 0.5 µg/plate
Controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 9-Aminoacridine, N-Ethyl-N'-nitro-N -nitrosoguanidine, 2-Nitrofluorene, 2-Aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium, other:
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
TA 100
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: Salmonella typhimurium strains TA 1535, TA1537, TA1538, TA98 and TA100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Test 1

Dose level [µg/plate]

Mean Revertant Colony Counts

TA 1535

TA 1537

TA 1538

TA 98

TA 100

+

+

+

+

+

50.0

16

15

11

10

12

10

22

24

116

121

15.0

13

15

10

9

13

10

24

27

101

108

5.0

11

11

12

8

10

9

25

25

100

109

1.5

17

15

12

8

15

12

29

22

99

112

0.5

11

12

10

11

14

14

25

25

99

106

0

13

14

16

14

15

9

21

22

106

101

Solvent

12

16

8

6

14

9

19

25

97

101

Positive control

77

2264

133

1565

115

44

226

81

494

597

 

Test 2

Dose level [µg/plate]

Mean Revertant Colony Counts

TA 1535

TA 1537

TA 1538

TA 98

TA 100

+

+

+

+

+

50.0

16

16

10

12

10

9

19

19

179

117

15.0

19

18

10

6

15

9

18

22

136

103

5.0

10

8

8

6

10

12

20

19

109

100

1.5

11

13

9

8

11

9

23

25

94

102

0.5

11

10

8

8

13

14

24

20

106

97

0

9

13

8

6

12

12

16

21

98

94

Solvent

9

11

9

12

9

11

21

25

90

106

Positive control

93

322

123

1086

81

40

97

68

381

376

Applicant's summary and conclusion