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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: Acceptable, well documented study report which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1982
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: III. Results from the Testing of 255 Chemicals.
Author:
Zeiger E et al.
Year:
1987
Bibliographic source:
Environ. Mutag. 9: Supplement 9: 1-110

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only four strains tested; Salmonella TA102 or E.coli WP2 not tested
Principles of method if other than guideline:
Method: other: preincubation according to Haworth et el. (1983)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): isobutyl acrylate
- Analytical purity: > 99%

Method

Target gene:
histidine operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat and hamster liver S9 fraction (Aroclor-induced)
Test concentrations with justification for top dose:
0; 100; 333; 1000; 3333; 10000 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see "any other information on materials and methods" section

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:
other: 3333 and 10000 ug/plate were slightly cytotoxic
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Salmonella typhimurium TA98, TA100, TA1535, TA1537

Any other information on results incl. tables

Strain TA 1535:

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

15

1.7

8

0.9

20

3.8

9

0.7

12

0.9

6

1.9

33         

 

 

 

 

22

0.3

 

 

18

1.2

 

 

100         

21

3.2

4

0.7

17

0.9

7

1.5

17

0.9

7

0

333         

16

1.3

6

1.8

17

0.7

5

0.9

17

1.9

4

0.3

1000         

15

0.9

2

1.2

17

1.2

4

1.5

15

0.6

4

0.7

3333         

15

1.5

1

0.3

17

1.9

5

0.3

14

1.9

5

1.2

10000         

7t

1.5

0

0

 

 

2

1

 

 

3

0.9

Positive Control

1787

100.6

34

3.2

570

55.9

41

9

454

55.9

37

8.2

Strain TA 100:

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

121

7

98

5.9

169

12.3

120

9.7

167

10.2

140

7.6

33         

 

 

 

 

117

7.7

 

 

149

3.8

 

 

100         

122

6.2

87

5.3

133

1.2

119

0.3

132

2.2

142

6.9

333         

119

1.5

96

2.8

147

2.3

112

7.3

147

2.6

118

10.4

1000         

91

5.2

82

2.2

144

11.4

97

0.9

145

3.3

117

2.7

3333         

69

1.2

74

2.9

141

4.2

94

8.5

136

9.3

118

3

10000         

0

0

91

1.2

 

 

94

11.1

 

 

118

9

Positive Control

1363

82.4

1423

157

2132

77.1

1869

161

2826

91.3

2501

160.8

Strain TA 98:

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

36

1.5

11

1.5

44

3.2

18

1.5

45

0.9

17

1.9

33         

 

 

 

 

39

3.5

 

 

42

2

 

 

100         

36

1.8

12

1.5

38

2.7

14

0.6

37

2

20

4.7

333         

36

2.2

13

5.7

39

3.2

12

0.9

40

1.3

15

1.2

1000         

28

1.9

11

0.9

46

1.8

13

0.7

42

3.2

15

3.1

3333         

24

4.5

10

0.6

42

2

9

1.9

42

0.9

12

0.6

10000         

34

2

9

0.9

 

 

8

1.3

 

 

9

0.9

Positive Control

266

69

253

32

1347

127.2

1442

219.6

1996

10.2

1565

202.9

Strain TA 1537:

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Equivocal)

10% RLI
(Negative)

10% RLI
(Negative)

Dose units

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0         

11

0.7

7

1

22

1.2

9

0.3

22

2

7

1

19

0.9

33         

 

 

 

 

18

0.9

 

 

33

0.9

 

 

 

 

100         

8

1.5

5

1.2

15

1.3

8

1.5

40

1.2

6

0.7

21

2.8

333         

8

0.6

4

1.2

18

3.3

6

0.3

34

6.5

5

1

15

0.7

1000         

7

2.5

6

1.5

15

2.3

7

0.9

22

1.2

6

0.7

13

3.3

3333         

10

0.9

3

0.9

20

2.2

4

0.3

27

0.9

6

0.3

15

1.2

10000         

t

2

1

 

 

3

1.2

 

 

3

0.7

11

1

Positive Control

398

172.5

91

4.1

399

43.7

128

23.4

89

2

131

34.3

351

49.3

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative