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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 1990- 29Oct 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- Adopted in 1981
- Deviations:
- no
- Principles of method if other than guideline:
- - Principle of test:Assess systemic toxicity of Zinc Diisononyldithiocarbamate (ZDiD) to the rat
- Short description of test conditions: ZDiD was administered to groups of twenty rats (10 males & 10 females for up to 13 weeks by admixture with the diet at fixed dose levels of 6, 60 and 500mg/kg/day with a group of twenty control rats received untreated diet alone. All animals were examined macroscopically on days 92 and 93 and the end of observation period. Histological examination of tissues was then intiated for the control and intermediate dosage, 60mg/kg/day.
- Parameters analysed / observed: - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- EC Number:
- 283-381-8
- EC Name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- Cas Number:
- 84604-96-6
- Molecular formula:
- C38H76N2S4Zn
- IUPAC Name:
- bis({[bis(3,5,5-trimethylhexyl)carbamothioyl]sulfanyl})zinc
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- BN 204 8789017
Date received - 1990
Expiry - stable for duration of study ( stored in dark at room temp)
Purity - n/a
Appearance- white powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- 50 male and 50 females CD rats of Sprague Dawley orogin (Crl:CD (SD) BR VAF Plus
Ordered from Charles River - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were 28 1 days old. and in weight range 63-81g
On arrival five animals from both gender was randomnly selected and used for health check purposes. For remaining rats a 14 day acclimitisation period was allowed after delivery and before start of treatments. Veterinary examination was performed on all animals before start of study.
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- test substance was administered by admixture with the diet. A pre-mix was prepared each week by grinding the test substnace directly into SDS lab animal diet no 2 & mixing in a Turbula mixer, until homogeneity ( minimum 7 mins mixing)
- Vehicle:
- other: SDS lab Animal diet 2
- Details on oral exposure:
- Samples of diets prepared during weeks 1, 6, 13 were analysed to check accuracy of preparation and performed by Huntingdon analytical services and found satisfactory
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of diets prepared during weeks 1, 6, 13 were analysed to check accuracy of preparation and performed by Huntingdon analytical services and found satisfactory
- Duration of treatment / exposure:
- Required dose of test item was administered to treated groups through out study by changing the concentrations of test material in diet on a weekly basis.
- Frequency of treatment:
- fed daily for 90 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg diet
- Remarks:
- control group of 10 males and 10 females
- Dose / conc.:
- 6 mg/kg diet
- Remarks:
- 10 females and 10 males
- Dose / conc.:
- 60 mg/kg diet
- Remarks:
- 10 females and 10 males
- Dose / conc.:
- 500 mg/kg diet
- Remarks:
- 10 males and 10 females
- No. of animals per sex per dose:
- 10 females and 10 males
- Control animals:
- yes, plain diet
- Details on study design:
- All rats were weighed at time of allocation of animals per group, then at weekly intervals throughout the study.- see table 1 in attachments
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- mortality, clinical signs twice a day, bodyweight weekly, food consumption (food intake per rat was calculated from the amount of food consumed in each cage and the number of rats surviving in each cage, efficiency of food utilisation, intake of test substance at weekly intervals, water consumption, daily monitoring, ophthalmoscopy before dosing and at week 13. Clinical pathology- Haematology, biochemistry, faecal analysis, terminal studies, organ weight analysis, macroscopic analysis and microscopic pathology. Statistical analysis was used for bodyweight, food consumption, organ weight and clinical pathology data.
- Sacrifice and pathology:
- Yes, see attachment A
- Statistics:
- Yes- see attachment A
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose group - systemic toxicity at this dosage was marked clinical signs (lethargy, reduced mean bodyweight and decreased food consumption.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- High dose groups only
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight summary attached
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- For the mid and low dose groups, no adverse effets were seen in clinical signs, bodyweights, food and water consumption, efficiency of food utilisation, opthalmoscopy, biochemistry and microscopic pathology, there were no notable differences between rats treated with zinc diisononyl dithiocarbamate at 6, or 60mg/kg.day and that of controls
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- Mid and low dose groups
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Analysis of blood revealed reduced PCV, Haemoglobin, RBC (males) and MCV values in high and mid dose groups
High dose group- 500mg/kg/day- reduced PCV, haemoglobin, RBC, MCV, increased reticulocyte and platelet levels, decrease in lymphocyte values and total white cell count. Blood slides showed polychomasia, hypochronasia and anisocytosis plus presence of Howell Jolly bodies
Low dose groups, no abnormal blood slides - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- slight biochemical changes observed at low and mid dose group, in creatinine, albumin and decreased cholesterol. All the changes were attributed to chance, being minor in nature and within the ranges of natural parameter variation for rats of this age and strain ( historical control data)
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Organ weights recorded at each post mortem examination at week 14 were analysed adjusting for final bodyweights as covariate, where appropriate. Results revealed an increase in adjusted adrenal weight for males treated with test item at 60mg/kg day in comparison with control as the only significant change
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related changes were observed following histopathological examination of preapred tissues from controls and rats of mid dose group.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 6 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- haematology
- immunology
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 60 mg/kg bw/day (nominal)
- System:
- endocrine system
- Organ:
- adrenal glands
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Administration of test substance in the diet of group at 500mg/kg/day resulted in treatment related deaths with the remainder of rats sacrificed for reasons of animal welfare before end of study. Pre-death findings included clinical signs, reduced body weights and food consumption. Analysis of blood samples revealed evidence of decreased red and white cell activity with further haematological and various biochemical parameters affected. The decrease in red cell values were accompanied by morphological changes, polychromasia, hypochromasia, anisocytosis, Howell Jolly bodies and nucleated red blood cells.
Few of the above changes were noted among rats in group 60mg/kg.day although a continuation of the anaemic and white cell efects, decreased PCV, haemoglobin, MCHC, MCV, lymphocyte and total white cell values with increased counts of platelets and reticulocyte. Despite the lack of histopathologcial changes, the haematological changes precluded the NOTEL as 60mg/kg/day.
The only notable finding at 6mg/kg/day was a decrease in MCHC values for male rats ( 2 out of 10 animals) No further haemtological findings were evident in PCV, RBC count, Hb, nor MVC, % reticulocytes and since this adpated response (variation also seen in controls) was minor and not considered of toxicological importance, a NOAEL was established at 6mg/kg/day - Executive summary:
NOAEL for test substance on repeat exposure was set at 6mg/kg/day
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