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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (E.coli strain is missing)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only four strains were used although OECD 471 orders five. 2-Aminoanthracene was the only positive control for the activation assays, which is not recommended by OECD 471.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Sodium dimethyldithiocarbamate
EC Number:
204-876-7
EC Name:
Sodium dimethyldithiocarbamate
Cas Number:
128-04-1
IUPAC Name:
sodium dimethyldithiocarbamate
Details on test material:
- Name of test material (as cited in study report): Wingstop B
- Lot/batch No.: TT 6-502, 385481
- Purity: no data
- Other: Wingstop B is a rubber chemical used to retard vulcanization.

Method

Target gene:
His auxotrophy, defective DNA repair activity (uvrB) and defective LPS barrier (rfa)

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: Ampicillin resistance (TA 98 and TA 100 only)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from livers of rats treated with Aroclor 1254
Test concentrations with justification for top dose:
–S9: 32, 63, 320 and 630 µg/plate (TA 100 and 1535 additionally: 10, 32, 100 and 320 µg/plate)
+S9: 10, 32, 100, 320 and 1000 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Nitrofluorene (2NF, -S9), Quinacrine mustard (QM, -S9), Sodium azide (NaN3, -S9); strain not reported All strains: 2-aminoanthracene (2-AA, +S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


Results and discussion

Test results
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables


Table 7.6.1 -A1 Gene mutation assay (plate incorporation)
Average revertants per plate in tester strains TA98, TA 100, TA 1535 and TA 1537 without S9-mix

Concentration [µg/plate]

Revertants/plate [mean of 3 plates]

TA 98

TA 100

TA 1535

TA 1537

Solvent control

47

63

14

8

32

57

140

20

17

63

45

204

37

21

320

51

234

59

22

630

47

185

41

21

Pos. control

1168

1191

875

1988

Solvent control

64

8

10

8

32

84

8

100

161

18

320

200

34

Pos. control

1056

931


Table 7.6.1-A2 Gene mutation assay (plate incorporation)
Average revertants per plate in tester strains TA98, TA 100, TA 1535 and TA 1537 with S9-mix (rat)

Concentration [µg/plate]

Revertants/plate [mean of 3 plates]

TA 98

TA 100

TA 1535

TA 1537

Solvent control

21

76

6

6

10

22

150

11

5

32

37

136

18

10

100

34

247

25

12

320

26

75

14

6

1000

23

5

5

Pos. control

1169

1034

128

128

Applicant's summary and conclusion