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EC number: 283-381-8 | CAS number: 84604-96-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Over 10 weeks
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Mammalian metabolic systems are expected to transform both dithiocarbamates and test substance by the same pathway, and both metabolites share the key thiuram disulphide functionality which will be the toxicologically-active portion of the molecules. Thus, it is considered to be a health-precautionary approach to read-across the mammalian cell gene mutation (mouse lymphoma) data on ziram & smaller dithiocarbamates to fill the corresponding gap in the Zinc diisononyldithiocarbamate dataset as the information is in the public domain with added benefit of reduction in further animal testing.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Ziram
- EC Number:
- 205-288-3
- EC Name:
- Ziram
- Cas Number:
- 137-30-4
- Molecular formula:
- C6H12N2S4Zn
- IUPAC Name:
- zinc bis(dimethyldithiocarbamate)
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- Over a 10 week period
- Details on study schedule:
- Not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/L air (nominal)
- Remarks:
- For two generations
- Dose / conc.:
- 72 mg/kg bw/day (nominal)
- Remarks:
- For two generations
- Dose / conc.:
- 207 mg/kg bw/day (nominal)
- Remarks:
- For two generations
- Dose / conc.:
- 540 mg/kg bw/day (nominal)
- Remarks:
- For two generations
- Dose / conc.:
- 5.3 mg/kg bw/day (actual dose received)
- Remarks:
- F0 males
- Dose / conc.:
- 14.8 mg/kg bw/day (nominal)
- Remarks:
- F0 males
- Dose / conc.:
- 37.5 mg/kg bw/day (nominal)
- Remarks:
- F0 males
- Dose / conc.:
- 6.1 mg/kg bw/day (nominal)
- Remarks:
- F0 females
- Dose / conc.:
- 16.8 mg/kg bw/day (nominal)
- Remarks:
- F0 females
- Dose / conc.:
- 42.8 mg/kg bw/day (nominal)
- Remarks:
- F0 females
- Dose / conc.:
- 5.6 mg/kg bw/day (nominal)
- Remarks:
- F1 males
- Dose / conc.:
- 16.7 mg/kg bw/day (nominal)
- Remarks:
- F1 males
- Dose / conc.:
- 42.7 mg/kg bw/day (nominal)
- Remarks:
- F1 males
- Dose / conc.:
- 6.3 mg/kg bw/day (nominal)
- Remarks:
- F1 females
- Dose / conc.:
- 18.4 mg/kg bw/day (nominal)
- Remarks:
- F1 females
- Dose / conc.:
- 47.5 mg/kg bw/day (nominal)
- Remarks:
- F1 females
- No. of animals per sex per dose:
- 30
- Control animals:
- yes
- Positive control:
- None listed
Examinations
- Parental animals: Observations and examinations:
- Food consumption, weight change, hair loss, sores, water consumption, lactation.
- Oestrous cyclicity (parental animals):
- Not listed
- Sperm parameters (parental animals):
- Not listed
- Litter observations:
- Weight
- Postmortem examinations (parental animals):
- No histopathological effects. Weight loss
- Postmortem examinations (offspring):
- No histopathological effects. Weight loss
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Body weight gains in high-dose males were significantly less than the controls during study weeks 18-10, 20-21 (83% cf) and 21-22 (90% cf).
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Males showed initial weight loss during the first week. Following that the was no significant difference during the test only at the highest dose.
Females showed significant weight loss compared to controls during the entire period of the test. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced compared to control
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No gross treatment related effects.
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No gross treatment related effects.
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No gross treatment related effects.
Effect levels (P0)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 37.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower body weights compared to controls beginning at day 4 precull up till day 14 and through lactation up to day 21.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower body weights compared to controls beginning at day 4 precull up till day 14 and through lactation up to day 21.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P1)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 37.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Absolute body weights for high-dose F1 females were significantly lower than the controls for the entire premating period (89-92%, study weeks 19-23, p<0.05; weeks 24-30, p<0.01). Significnatly lower body weight gains (67-87%) occurred only during study weeks 18-19 (p<0.05, 23-24 and 24-25 (p<0.01).
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption by the high-odse F1 females was also significantly less than the controls throughout remating (p<0.01; weeks 21-22 and 28-29, p<0.05).
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Diferences in absolute and relative organs weights of the high-dose male and female F0 and F1 groups as compared to controls are consistent with reduced body weights of these animals.
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Key result
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 37.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 37.5 mg/kg bw/day (nominal)
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
Applicant's summary and conclusion
- Executive summary:
This structural analogue has been used to typify the behaviour of zinc dithiocarbamate compounds. As the ligands in Arbestab Z are far larger there is less likelihood that there will be as significant effects on developmental toxicity from the dimethyl analogue compared to the isononyl ligands in Arbestab Z. This is a worsst case scenario but typifies the possible biochemical interations in mammalian foetal development.
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