Registration Dossier
Registration Dossier
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EC number: 950-052-1 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Zirconium acetate considered a good surrogate for testing as this is a non-corrosive form of the substance and is water soluble
The source of data for the US Federal publication appears to lead back to a European REACH registration. The potential lead registrant has been contacted and attempts made to access the data; at the time of submission, there has been no response and the data owner is not known.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Justification for study design:
- Appears to follow OECD guidelines; accepted by peer reviewed US publication
Assumed to be GLP compliant, but no indication of data owner or testing facility provided in publication.
Test material
- Reference substance name:
- Zirconium acetate
- EC Number:
- 231-492-7
- EC Name:
- Zirconium acetate
- Cas Number:
- 7585-20-8
- Molecular formula:
- C2H4O2.xZr
- IUPAC Name:
- Zirconium acetate
Constituent 1
- Specific details on test material used for the study:
- Not specified
Zirconium acetate considered a good surrogate for testing as this is a non-corrosive form of the substance and is water soluble
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- The substance will dissociate in water, but zirconium will remain soluble under acidic conditions of the stomach when ingested.
- Duration of treatment / exposure:
- Males exposed for 32 days and up to 50 days (4 days post-partum) for females. Exposure took place prior to and during mating period
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Three groups of 4 rats per sex were administered with zirconium acetate by oral gavage at doses of 100, 300 and 1000 mg/kg bw/day
Dose expressed as anhydrous form of zirconium acetate - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Not specified in review
- Postmortem examinations (parental animals):
- Not specified in review
- Postmortem examinations (offspring):
- Not specified in review
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Other effects:
- no effects observed
Effect levels (F1)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No clinical signs or effects on reproduction or development were reported.
The No Observed Adverse Effect Level (NOAEL) for repeated dose toxicity, reproductive toxicity and for developmental toxicity was considered to be in excess of 1000 mg/kg bw/day zirconium acetate anhydrous.
This equates to ca. 280 mg/kg/day Zr 4+ and in turn, using a nominal molecular weight of 231 for the registered substance, the NOAEL for the zirconium oxynitrate is greater than 700 mg/kg/day
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.
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