Registration Dossier
Registration Dossier
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EC number: 238-677-1 | CAS number: 14634-93-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Methodology and results insufficient reported
Data source
Reference
- Reference Type:
- publication
- Title:
- The toxicology of resin Vulcacite P Extra N accelerator of vulcanization
- Author:
- Yalkut SI
- Year:
- 1 971
- Bibliographic source:
- Gig. Sanit., 36, 28-31 (in Russian language)
Materials and methods
- Principles of method if other than guideline:
- For the evaluation of the subchronic/chronic toxicity of zinc ethylphenylthiocarbamate 10 rats each (no information of strain and sex) received by gavage 6 times weekly 500 mg/kg bw for 1.5 months, 100 or 10 mg/kg bw for 4 months and 1 mg/kg bw for 10 months.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Zinc bis(N-ethyl-N-phenyldithiocarbamate)
- EC Number:
- 238-677-1
- EC Name:
- Zinc bis(N-ethyl-N-phenyldithiocarbamate)
- Cas Number:
- 14634-93-6
- Molecular formula:
- C18H20N2S4Zn
- IUPAC Name:
- zinc bis(N-ethyl-N-phenyldithiocarbamate)
Constituent 1
- Specific details on test material used for the study:
- No data
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 1.5, 4 or 10 month
- Frequency of treatment:
- 6 times weekly
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- 1.5 month
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- 4 month
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Remarks:
- 4 month
- Dose / conc.:
- 1 mg/kg bw/day (nominal)
- Remarks:
- 10 month
- No. of animals per sex per dose:
- 10 rats/dose
- Control animals:
- not specified
- Details on study design:
- Mortality, body weight, clinical biochemistry and haematological finding and histopathological examination.
Examinations
- Observations and examinations performed and frequency:
- Mortality, body weight, clinical biochemistry and haematological finding and histopathological examination.
- Sacrifice and pathology:
- AHistopathological results were reported.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At a dosage of 500 mg/kg bw 3 rats died after 32, 34 or 41 days. The other dosages did not cause any deaths.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At a dose of 500 mg/kg bw the body weight gain was 12% (after 1.5 months) lowever than in the control group, at a dosage of 100 mg/kg bw the body weight gain was 16% (after 2 months) lower than in the control group.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- In the haemogram the both upper dosages caused "strong disorders". With a dosage of 10 mg/kg bw at the end of the thrird months there was a trend towards a reduced erythrocyte number and at the end of the experiment a strong
reticulocytosis was seen. Furthermore, the prothrombin time was decreased after 3 months (administration of 100 mg/kg bw) or 4 months (administration of 10 mg/kg bw). - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The cytochrome oxidase activity in the liver was decreased after 4 months (100 mg/kg bw), the ceruloplasmin activity was decreased 4 months after administration of 100 mg/kg bw and 3 months after administration of 10 mg/kg bw.
Furthermore, after the administration of 100 mg/kg bw an increase in the catalase index (p <0.05) was observed.. - Urinalysis findings:
- not specified
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight granular degeneration of liver cells, increased aveolar and histocytic cells in the lungs, peribronchial infiltration, dilatation and hyperemia of the renal vessels, granular degenerationof the tubular epithelium with isolated necroses as well as dilated spleen vessels were observed at a dosage of 100 mg/kg bw and 10 mg/kg bw. At a dosage of 100 mg/kg bw numerous megakaryocytes were found in the spleen pulp.
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- haematology
- histopathology: non-neoplastic
- Remarks on result:
- other: The oral administration of 1 mg/kg bw over 10 months revealed no effects compared to controls.
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 10 mg/kg bw/day (nominal)
- System:
- haematopoietic
- Organ:
- kidney
- liver
- spleen
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Applicant's summary and conclusion
- Conclusions:
- The oral administration of 1 mg/kg bw over 10 months revealed no effects. With higher doses haematological and histopathological findings (liver, lung, spleen) were repoted.
- Executive summary:
After a subchronic/chronic oral administration of 500 mg/kg bw of zinc ethylphenyldithiocarbamate to rats for 1.5 months some cases of deaths occurred. A dosage of 100 mg/kg bw or 10 mg/kg bw changes in the haemogram, the prothrombin time,and the cytochrome oxidase were observed. Histopathological effects on the liver, lung and kidneys were detected. The oral administration of 1 mg/kg bw over 10 months revealed no effects.
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