Registration Dossier
Registration Dossier
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EC number: 283-381-8 | CAS number: 84604-96-6
Toxicological information
Developmental toxicity / teratogenicity
Currently viewing:
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Structural analogue data available on ECHA site and published data on multiple databases
According to the REACH regulatory text and accompanying guidance, a reproductive/developmental toxicity screening study (OECD 421 or 422) does not need to be conducted if a pre-natal developmental study (OECD 414) is available. No effects on fertility or development were reported in three studies (two OECD 414 and one equivalent to OECD 416) of ziram at doses that did not also cause systemic toxicity to the parental animals. The terminal examinations in the repeated-dose study of test substance (Zinc diisononyl dithiocarbamate) included recording the weights of the ovaries and testes and macroscopic examination of these organs as well as the seminal vesicles, uterus and vagina. Histopathological examination of the ovaries, testes and uterus was also carried out on all animals. None of these examinations found any effect of Arbestab Z on the reproductive organs. Considering this, together with the weight-of-evidence from the studies on ziram, , it is not justifiable, scientifically or from an animal welfare perspective, to conduct further testing on Arbestab Z. It is considered suitably health-precautionary to use data on ziram to fill the corresponding gaps in the Arbestab Z dataset.
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 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
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:
- Crj: CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Equiv to Oecd 414 - pregnant rats, tested at 0,1,4,16 and 64mg/kg/day
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 0,1,4,16 64 mg/kg /day on days 6-15 of gestation
- Frequency of treatment:
- 6-15 gestation days
- Duration of test:
- 20 days gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 mg/kg bw/day (nominal)
- Dose / conc.:
- 4 mg/kg bw/day (nominal)
- Dose / conc.:
- 16 mg/kg bw/day (nominal)
- Dose / conc.:
- 64 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25
Examinations
- Maternal examinations:
- Yes
- Ovaries and uterine content:
- No
- Fetal examinations:
- Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Salivation in the last days of dosing for the high-dose animals (16 and 64mg/kg bw/day)
- Dermal irritation (if dermal study):
- effects observed, treatment-related
- Description (incidence and severity):
- Generalized hair loss for the high-dose animals (16 and 64mg/kg bw/day)
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased for the 16 and 64 mg/kg bw/day groups.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Decreased for the 16 and 64 mg/kg bw/day groups.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Increased for the 16 and 64 mg/kg bw/day groups
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- 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
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- 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:
- no effects observed
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 16 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower weights compared to controls
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- no effects observed
- External malformations:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Dose-related incidence of diaphragmatic lesions and protrusion of the liver or a LOAEL of 16mg/kg bw/day
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- fetal/pup body weight changes
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 16 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- visceral malformations
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 4 mg/kg bw/day (nominal)
- Treatment related:
- no
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- no
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
