Ziram

Genetic toxicity: in vitro

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

No E.coli strains were tested.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 84-2

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ziram

EC Number:

205-288-3

EC Name:

Ziram

Cas Number:

137-30-4

Molecular formula:

C6H12N2S4Zn

IUPAC Name:

ziram

Constituent 2

Reference substance name:

zinc bis dimethyldithiocarbamate

IUPAC Name:

zinc bis dimethyldithiocarbamate

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

Untreated negative controls:

no

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

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 µg/plate was bacteriotoxic. Therefore, 50 µg/plate was chosen as the highest concentration.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 µg/plate was bacteriotoxic. Therefore, 50 µg/plate was chosen as the highest concentration.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 µg/plate was bacteriotoxic. Therefore, 50 µg/plate was chosen as the highest concentration.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Remarks:

genotoxicity was observed in the presence of metabolic activation above 50 µg/plate

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 µg/plate was bacteriotoxic. Therefore, 50 µg/plate was chosen as the highest concentration in the first tests. In later tests, 150 µg/plate were used as the highest concentration.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

not examined

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

500 µg/plate was bacteriotoxic. Therefore, 50 µg/plate was chosen as the highest concentration.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

True negative controls validity:

not examined

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