Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-324-9 | CAS number: 13746-89-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non guideline and non GLP study. Basic data given. Limitations in design and reporting. No NOAEL was identified.
Data source
Reference
- Reference Type:
- publication
- Title:
- Zirconium, Niobium, Antimony, Vanadium and Lead in Rats : Life term studies
- Author:
- Schroeder, H.A. et al.
- Year:
- 1 969
- Bibliographic source:
- J. Nutrition, 100: 59-68
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Zirconium sulphate
- EC Number:
- 238-694-4
- EC Name:
- Zirconium sulphate
- Cas Number:
- 14644-61-2
- IUPAC Name:
- 14644-61-2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: Weanlings
- Housing: 4 per cage
- Diet: ad libitum
- Water: ad libitum, basal water
Administration / exposure
- Route of administration:
- other: oral: feed and drinking water
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET
- Mixing appropriate amounts with: composed of seed rye flour (60% ), dry skim milk (30 % ), corn oil (9% ) and iodized sodium chloride (1% ) with added vitamins and ferrous sulfate) - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- lifetime
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
5 ppm
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
2.66 µg/g
Basis:
nominal in diet
- No. of animals per sex per dose:
- 50 or more
- Control animals:
- yes, concurrent no treatment
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly (weaning time to six weeks of age); then monthly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: monthly
- Anaesthetic used for blood collection: Yes
- Animals fasted: Yes, partly (18 hours before collection)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: monthly
- Animals fasted: Yes, partly (18 hours before collection)
- Parameters examined: serum glucose, cholestrol
URINALYSIS: Yes
- Time schedule for collection of urine: not data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: glucose, whole protein - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Zirconium had no effects on the growth or mature weights of the animals. Survival and longevity were similar to the control group. Female rats fed with zirconium showed higher serum glucose levels at 30, 150, 540 days of age. Furthermore glucose in urine was significantly increased in the animals at 18 months of age. 23% of the control animals were also affected. No significant effects were seen regarding the whole protein content in urine.
Serum cholesterol of fasted animals was significantly higher in males treated with zirconium. The test substance was not tumorigenic and accumulation of zirconium in rat tissue was very poor.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
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.
