Sodium dibutyldithiocarbamate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dibutyldithiocarbamate

EC Number:

205-238-0

EC Name:

Sodium dibutyldithiocarbamate

Cas Number:

136-30-1

Molecular formula:

C9H19NS2.Na

IUPAC Name:

sodium (dibutylcarbamothioyl)sulfanide

Details on test material:

- Physical state: straw-coloured liquid
- Analytical purity: 47.5% aqueous solution of density 1.086 g/ml
- Lot/batch No.: 8905275
- Storage condition of test material: kept at room temperature, in the original container and protected from light.

Method

Target gene:

DNA base pairs

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:

derived from rat liver (S-9 mix)

Test concentrations with justification for top dose:

50, 158, 500, 1580 and 5000 µg per plate (for 47.5% aqueous solution of the substance), corresponding to 23.75, 75.05, 237.5, 750.5 and 2375 µg per plate for pure (anhydrous) substance

Vehicle / solvent:

- Solvent used: distilled water

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

with and without S-9

Controls 2

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Controls 3

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Controls 4

Positive controls:

yes

Positive control substance:

9-aminoacridine

Controls 5

Positive controls:

yes

Positive control substance:

sodium azide

Controls 6

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Incubation period: 2 days

NUMBER OF REPLICATIONS: Triplicate

DETERMINATION OF CYTOTOXICITY
- Method: examination for the presence of a background lawn of non-revertant colonies

Evaluation criteria:

No data

Statistics:

No data

Results and discussion

Test results

Key result

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:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

CYTOTOXICITY:
The lowest level of SDBC causing visible thinning of the background lawn of non-revertant cells was 5000 µg/plate. This was therefore selected as the top exposure level for use in the main assays.

Any other information on results incl. tables

Summary of the revertant colony means:

Plate N°		Addition (µg)	S-9mix: + present; - absent	Revertant colony means
				TA98 (Test 1)	TA98 (Test 2)	TA100 (Test 1)	TA100 (Test 2)	TA1535 (Test 1)	TA1535 (Test 2)	TA1537 (Test 1)	TA1537 (Test 2)
1	None; sterility check		+	0	0	0	0	0	0	0	0
2	SDBC sterility check	5000	-	0	0	0	0	0	0	0	0
3	SDBC	5000	+	14	24	29	28	6	7	8	6
4	SDBC	1580	+	28	33	70	55	14	12	7	7
5	SDBC	500	+	34	32	108	109	15	13	7	7
6	SDBC	158	+	38	32	111	108	15	13	7	6
7	SDBC	50	+	36	33	113	111	14	14	7	7
8	Distilled water		+	37	32	110	110	13	13	8	7
9	SDBC	5000	-	18	29	109	109	13	12	5	8
10	SDBC	1580	-	29	34	109	111	14	14	8	7
11	SDBC	500	-	33	35	112	111	15	15	8	6
12	SDBC	158	-	34	31	112	111	14	15	7	8
13	SDBC	50	-	33	34	112	111	14	16	7	7
14	Distilled water		-	36	31	110	111	14	16	8	8
15	Benzo(a)pyrene		-	31	26	104	102	12	16	6	6
16	Benzo(a)pyrene		+	260	393	590	470	846	494	218	171
17	2-Nitrofluorene		-	440	909	531	673	644	416	167	146
18	None; 10E-6 dilution of bacterial culture only		-	115	113	115	113	114	116	114	113

Applicant's summary and conclusion

Conclusions:

Negative in the Ames test.

Executive summary:

The ability of sodium dibutyldithiocarbamate (SDBC) in its manufactured form (as 47.5% aqueous solution) to induce gene mutations in bacteria was studied in Ames test with Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at test concentrations 50, 158, 500, 1580 and 5000 µg per plate (corresponding to 23.75, 75.05, 237.5, 750.5 and 2375 µg per plate for pure (anhydrous) substance), in the presence and absence of metabolic activation (Life Science Research Ltd, 1990). The study was performed in accordance with OECD Guideline 471 and EPA OTS 798.5265 and under GLP. The lowest level of SDBC causing visible thinning of the background lawn of non-revertant cells was 5000 µg/plate. The substance did not induce a statistically significant increase in the number of revertants in any strain, both with and without metabolic activation, indicating that sodium dibutyldithiocarbamate (SDBC) is not mutagenic in Ames test.