Ziram

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

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 positive control.)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

yes

Remarks:

No positive control.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 84-2

GLP compliance:

yes

Type of assay:

micronucleus 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: 98.8%

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River, USA
- Age at study initiation: 5-6 weeks
- Weight at study initiation: no data

Administration / exposure

Route of administration:

oral: feed

Duration of treatment / exposure:

89 days

Frequency of treatment:

daily

Post exposure period:

none

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 25, 75, 225 and 675 ppm
Basis:
nominal in diet

No. of animals per sex per dose:

50

Control animals:

yes, plain diet

Examinations

Tissues and cell types examined:

Peripheral blood

Details of tissue and slide preparation:

Peripheral blood smears were prepared from 5 male and 5 female animals in each group. The smears were stained using Giemsa then examined by light microscopy for the presence of micronuclei in normochromatic and polychromatic erythrocytes (1000 cells of each type were examined from each animal). The ratio of polychromatic to normochromatic erythrocytes was assessed by examination of at least 1000 erythrocytes from each animal.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

not examined

Any other information on results incl. tables

Dose level [ppm]	Ration p/n (mean)	Incidence mnp (mean)	Incidence mnn (mean)
Control	0.108	0.9	1.1
25*	0.143	0.6	1.7
75**	0.124	1.2	2.0
225	0.095	0.8	0.7
675	0.135	0.5	1.2

p/n Ratio of polychromatic to normochromatic erythrocytes

mnp No. of micronucleated cells observed per 1000 polychromatic erythrocytes

mnn No. of micronucleated cells observed per 1000 normochromatic erythrocytes

* Prepared at 29 ppm initially to allow for loss during storage

** Prepared at 83 ppm initially to allow for loss during storage