Registration Dossier
Registration Dossier
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EC number: 238-677-1 | CAS number: 14634-93-6
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Teratological studies of zinc ethylphenyldithiocarbamate (ZEPC), a vulcanization accelerator for rubber in rats
- Author:
- Nakaura S, Tanaka S, Kawashima K, Takanaka A, Omori Y
- Year:
- 1 983
- Bibliographic source:
- J Toxicol Sci 8, 337
- Reference Type:
- publication
- Title:
- Fetal toxicity of zinc ethylphenylditioncarbamate (ZEPC) (3.). Mechanism of formation of methemoglobin caused by ZEPC
- Author:
- Nakaura S, Kawanishi T, Ohno Y, Kawashima K, Tanaka S, Takahashi S, Takanaka A, Omori Y, Matumoto K
- Year:
- 1 985
- Bibliographic source:
- J Toxicol Sci 10, 252
Materials and methods
- Principles of method if other than guideline:
- For the examination of the effects of zinc ethylphenylthiocarbamate (ZEPC) to the prenatal and postnatal development, gravid rats received 31.2, 62.5, 125 or 250 mg ZEPC/kg bw suspended in olive oil from day 7 to 15 of gravidity by oral gavage.
- GLP compliance:
- 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
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No data
- Duration of treatment / exposure:
- From day 7 to 15 of gravidity.
- Frequency of treatment:
- Daily
- Duration of test:
- No data.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 31.2 mg/kg bw/day (nominal)
- Dose / conc.:
- 62.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data.
Examinations
- Maternal examinations:
- In a follow up experiment, a haemogram was conducted on rats which received daily doses of 125, 250, 500 or 1000 mg zinc ethylphenyldithiocarbamate/kg bw from day 7 to 9.
- Ovaries and uterine content:
- No data
- Fetal examinations:
- Haemogram
- Statistics:
- No data
- Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- A decrease in the number of erythrocytes, haemoglobin amount and haemotocrit value and an increase in microcyte count were observed in the gravid rats.
- Clinical biochemistry findings:
- not specified
- 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:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- effects observed, treatment-related
- Description (incidence and severity):
- With an increased dose of zink ethylphenylthiocarbamate an increased fetal mortality was observed. A dose of 250 mg zink ethylphenylthiocarbamate was lethal for all fetuses.
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Remarks on result:
- other: not specified
Maternal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: haematogram
- Description (incidence and severity):
- A decrease in the number of erythrocytes, haemoglobin amount and haemotocrit value and an increase in microcyte count were observed in the gravid rats.
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A decreased body weight of the fetuses of the dams of the 62.5 and 125 mg/kg bw group was observed.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): effects observed, treatment-related
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): A decreased body weight of the fetuses of the dams of the 62.5 and 125 mg/kg bw group was observed. - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Description (incidence and severity):
- No external, visceral or skeletal anomalies were found in any of the dose groups examined.
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No external, visceral or sceletal anomalies were found in any of the dose groups examined.
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Zinc ethyphenyldithiocarbamate has fetal toxic effecs, though the compound has no teratogenic effects and the fetal death od ZEPC may be due to an action of the agent on the erythrocytes of pregnant rats. It is concluded that methemoglobinemia in pregnant rats may be responsible for the in utero toxicity observed after exposure to ZEPC.
Applicant's summary and conclusion
- Conclusions:
- Zinc ethyphenyldithiocarbamate has fetal toxic effects (fetal deaths, low body weights, skeletal variations, vhangeds of the haematogram), however no external, visceral or sceletal anomalies were found in any of the dose groups examined.
- Executive summary:
For the examination of the effects of zinc ethylphenylthiocarbamate (ZEPC) to the prenatal and postnatal development, gravid rats received 31.2, 62.5, 125 or 250 mg ZEPC/kg bw suspended in olive oil from day 7 to 15 of gravidity by oral gavage. Zinc ethyphenyldithiocarbamate has fetal toxic effects (fetal deaths, low body weights, skeletal variations and changes of the haematogram), however no external, visceral or skeletal anomalies were found in any of the dose groups examined. The toxic effects found may be due to methemoglobinemia.
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