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EC number: 205-288-3 | CAS number: 137-30-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Animals were not observed daily after week 4 and histopathology was carried out on a limited number of organs. Additionally urinalysis and functional observations were not made because the protocol is conform to the OECD 408 guideline of 1981.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Ziram
- EC Number:
- 205-288-3
- EC Name:
- Ziram
- Cas Number:
- 137-30-4
- Molecular formula:
- C6H12N2S4Zn
- IUPAC Name:
- ziram
- 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
- Lot/Batch number: 8331 AA
- Description: White powder
- Purity: 98.7%
- Stability: Confirmed as 98.7%. Sample taken 1990-11-30, analysis 1991-01-04.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Portage, Portage, Michigan, USA
- Age at study initiation: 28 days
- Weight at study initiation: 157-188 g (♂) and 117-144 g (♀)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 ppm/day. The concentration of test material in the low dose level was increased by 15% above nominal to compensate losses during storage.
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CLINICAL SIGNS
- Once daily on working days for the first four weeks, then once weekly.
MORTALITY
- Twice daily.
BODY WEIGHT
- On allocation, day 0 and then once weekly.
FOOD CONSUMPTION
- Once daily
FOOD EFFICIENCY
- Where appropriate, calculation from bodyweight and food consumption.
COMPOUND INTAKE
- Group mean was calculated weekly from group mean bodyweight, food consumption data and dietary inclusion levels of the test material.
WATER CONSUMPTION
- Once daily
OPHTHALMOSCOPIC EXAMINATION:
- For control and high-dose animals at pre-test and during week 13.
HAEMATOLOGY:
- During week 13.
- Parameters: haematocrit, erythrocyte count, haemoglobin, mean corpuscular volume, mean corpuscular haemoglobin concentration, platelet count, total leukocyte count, differential leukocyte count, cell morphology, thrombotest
CLINICAL CHEMISTRY:
- During week 13.
- Parameters: glucose, blood urea nitrogen, creatinine, total bilirubin, total cholesterol, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, calcium, phosphorus, sodium, potassium, chloride, albumin, total protein, albumin/globulin ratio - Sacrifice and pathology:
- ORGAN WEIGHTS
- Brain, heart, liver, spleen, thyroid, kidneys, adrenals, uterus, testes, pituitary, ovaries
GROSS PATHOLOGY:
- All dose groups.
HISTOPATHOLOGY:
- The following tissues were removed from all animals and preserved in buffered 10% formalin (except eyes: Davidson’s fixative):
adrenals, aorta, brain (medullary, cerebellar, cortical sections), caecum, colon, duodenum, eyes, femur (with joint), Harderian gland, head (nasal cavity, paranasal sinuses, oral cavity, nasopharynx, middle ear, teeth, lachrymal gland, Zymbal’s gland), heart, ileum, jejunum, kidneys, larynx, liver, lungs (all lobes and mainstem bronchi), lymph nodes (cervical, mesenteric), mammary glands, oesophagus, ovaries, pancreas, pharynx, pituitary, prostate, rectum, salivary glands, sciatic nerve, seminal vesicles, skeletal muscle, skin, spinal cord (cervical, thoracic, lumbar), spleen, sternum, stomach, testes with epididymides, thymus, thyroid/parathyroid, tongue, trachea, urinary bladder, uterus (corpus, cervix), vagina and other macroscopically abnormal tissues - Statistics:
- All analyses were carried out separately for male and female.
Data relating to food and water consumption were analysed on a cage basis. All other parameters were carried out using the individual animal as basis.
Histopathological findings were analysed using Fisher’s exact analysis.
The following tests were used for food and water consumption, bodyweight, relative organ weight and clinical pathology data:
- If the data consisted predominantly of one particular value (relative frequency of the mode exceeds 75%), the proportion of animals with values different from the mode was analysed by appropriate methods. Otherwise:
- Bartlett’s test was applied to test for heterogeneity of variance between treatments. Where significant (at the 1% level) heterogeneity was found, a logarithmic transformation was tried to see if a more stable variance structure could be obtained.
- If no significant heterogeneity was detected (or if a satisfactory transformation was found), a one-way analysis of variance was carried out. If significant heterogeneity of variance was present, and could not be removed by a transformation, the Kruskal-Wallis analysis of ranks was used.
- Except for pre-dose data, analyses of variance were followed by Student’s ‘t’ test and Williams’ test for a dose-related response, although only the one thought most appropriate for the response pattern observed has been reported. The Kruskal-Wallis analyses were followed by the non-parametric equivalents of the ‘t’ test and Williams’ test (Shirleys’ test).
Where appropriate, during absolute organ weight analysis, analysis of covariance was used in place of analysis of variance.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS
Slightly higher incidence of hair loss in males/females given 300 and 1000 ppm. Not apparent among controls or low-dose group and not confirmed at post mortem examination.
MORTALITY
One control female during week 13. Examinations revealed congestion in the lungs, the smell of ether in the thoracic cavity and a pale subcapsular area on the median liver-lobe.
BODY WEIGHT AND WEIGHT GAIN
Dosage-dependent reduction among males and females at 300 and 1000 ppm during week 1. At the dosage of 1000 ppm trend continued though less markedly.
FOOD CONSUMPTION
Dosage-related reduced among males and females given 300 and 1000 ppm during week 1. At 1000 ppm trend continued to a lesser degree.
COMPOUND INTAKE
Means over the treatment period are:
7.4, 21.4, 67.8 mg/kg bw/day for males
8.8, 24.2, 76.9 mg/kg bw/day for females
HAEMATOLOGY
Significant decrease in mean RBC (red blood cell) values for animals given 1000 ppm. Corresponding increases in mean corpuscular haemoglobin concentration (MCHC) values were also noted.
CLINICAL CHEMISTRY
Urea nitrogen increase in animals given 1000 ppm and females given 100 and 300 ppm.
Dosage-related decrease in total protein in females, mainly due to reduction in albumin, and a lowering in serum calcium in all treated groups.
Increase in serum alkaline phosphatase (AP) in females given 1000 ppm.
ORGAN WEIGHTS
Higher brain weight in animals given 300 or 1000 ppm. In addition higher spleen weights were apparent for rats given 1000 and females given 300 ppm. Greater testes and ovary weights were also noted at 1000 ppm.
HISTOPATHOLOGY: NON-NEOPLASTIC
Stomach: Minimal epithelial hyperplasia of the non-glandular stomach was observed in animals given 1000 and one female given 300 ppm. Because of lacking significance according to Fisher’s exact analysis the effect was considered to be of no toxicological relevance.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 7.4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Decrease in serum calcium and blood proteins and increase in urea nitrogen
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- < 7.4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effects observed at the lowest concentration tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 7.5.1 -B1 Oral 90 day toxicity in rats by ziram |
||||||||||
Endpoint / Dose |
Control |
100 ppm |
300 ppm |
1000 ppm |
Dose-response +/– |
|||||
♂ |
♀ |
♂ |
♀ |
♂ |
♀ |
♂ |
♀ |
♂ |
♀ |
|
Mortality |
1 |
– |
– |
|||||||
Clinical signs |
hairloss |
– |
– |
|||||||
Food consumption |
↓ 13% |
↓ 17% |
↓ 25% |
↓ 25% |
+ |
+ |
||||
Food efficiency |
Impaired week 1 |
– |
+ |
|||||||
Body weight gain |
↓ 18% |
↓ 18% |
↓ 33% |
↓ 32% |
+ |
+ |
||||
Haematology |
||||||||||
RBC |
↓ |
↓ |
+ |
+ |
||||||
MCHC |
↑ |
↑ |
↑ |
↑ |
+ |
+ |
||||
Blood chemistry |
||||||||||
Urea nitrogen |
↑ |
↑ |
↑ |
↑ |
+ |
+ |
||||
Total protein |
↓ |
↓ |
↓ |
– |
+ |
|||||
Serum Ca2+ |
↓ |
↓ |
↓ |
↓ |
↓ |
↓ |
– |
+ |
||
Serum AP |
↑ |
– |
+ |
|||||||
Organ weight |
||||||||||
Brain |
↑ |
↑ |
↑ |
↑ |
– |
– |
||||
Spleen |
↑ |
↑ |
↑ |
+ |
+ |
|||||
Testes or ovary |
↑ |
↑ |
↑ |
– |
– |
|||||
↑, ↓: statistically significant increase and decrease, respectively |
Applicant's summary and conclusion
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