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EC number: 950-052-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of rats had zirconium added to the diet and drinking water in a lifetime study to evaluate the effects of 5 trace metals.
- GLP compliance:
- no
- Remarks:
- Study predates introduction of GLP
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pregnant females were purchased from BLU: (LE) strain, Blue Spruce Farms, Inc., Altamont, New York, and the offspring were born and weaned in the study laboratory.
- Housing: 4 per cage
- Diet: ad libitum
- Water: ad libitum
- Route of administration:
- oral: unspecified
- Details on route of administration:
- Combination of drinking water and diet
- Vehicle:
- other: drinking water and diet
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- From weaning to natural death (a maximum of 1347 days).
- Dose / conc.:
- 0.79 mg/kg bw/day (nominal)
- Remarks:
- males
- Dose / conc.:
- 0.89 mg/kg bw/day (nominal)
- Remarks:
- females
- No. of animals per sex per dose:
- 56 male and 58 female
- Control animals:
- yes, plain diet
- Details on study design:
- The test drinking water contained 5 ppm zirconium sulfate and the experimental rats also were fed a diet containing 2.66 μg/g zirconium. Using time-weighted average body weight and default water consumption in Long-Evans rats, the dose of 5 ppm zirconium sulfate in drinking water was converted to 0.60 mg/kg-day for males and 0.67 mg/kg-day for females. The dose of 2.66 mg/kg zirconium in feed was converted (also using time-weighted average body weights and food consumption) to 0.19 mg/kg-day for males and 0.22 mg/kg-day for females. Because the rats ingested both drinking water and feed, the doses were summed for a total equivalent dose (TED) of 0.79 mg/kg-day in males and 0.89 mg/kg-day in females.
- Observations and examinations performed and frequency:
- The rats were weighed weekly from weaning until 6 weeks of age, and then monthly. As the rats died, they were weighed and dissected to identify grossly visible tumors and other lesions in the heart, lung, kidney, liver, and spleen.
- Other examinations:
- Blood pressure and blood samples were also taken regularly.
Portions of heart, lung, kidney, liver and spleen were frozen and later ashed and analysed for the elements given. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Description (incidence):
- There was no significant difference in survival of the zirconium-administered rats compared to controls. Mortality was not linked to treatment.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Zirconium did not consistently affect the growth rates of the rats . Males administered zirconium were significantly heavier than controls at 30, 150, and 180 days and lighter than controls at 360 and 540 days, while females were significantly heavier than controls at 30, 150, and 540 days.
No differences were observed in the mean body weights of the rats administered zirconium compared to controls, while the hearts of males administered zirconium weighed 14.6% less than controls, the hearts of females weighed 7.4% more. - Description (incidence and severity):
- Females administered zirconium showed significantly higher fasting serum glucose levels than controls and males administered zirconium had significantly higher cholesterol levels. Glycosuria (glucose in the urine) was noted in 23% of the controls and in 52% of 56 rats (study does not say whether in males or females) administered zirconium (significantly different by chi-square analysis at p < 0.01)
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant increase was reported in the number of tumors in rats administered zirconium compared to the controls
- Dose descriptor:
- LOAEL
- Effect level:
- 0.79 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- Dose descriptor:
- LOAEL
- Effect level:
- 0.89 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- female
- Basis for effect level:
- clinical biochemistry
- Critical effects observed:
- no
- Conclusions:
- A LOAEL of 0.79 mg/kg-day (males) and 0.89 mg/kg-day (females) is identified based on significantly increased incidence of glycosuria, higher fasting glucose levels in females and higher cholesterol levels in males. A NOAEL is not determined because only one dose (in addition to controls) was tested.
TABLE 1
Weights of rats given zirconium,
Age (days) |
Control (g) |
Zirconium (g) |
Males 30 60 90 120 150 180 360 540 |
72.1± 4.21 189.5± 6.0 270.0± 8.9 312± 9.3 341.5± 8.9 364.7±8.7 443.8± 14.9 507.4±16.6 |
88.5± 2.32 204.0± 4.7 285.7± 6.2 313.7± 8.7 377.5± 6.33 392.0 ± 6.54 405.2± 8.45 469.0 ± 8.13 |
Females 30 60 90 120 150 180 360 540 |
64.7± 2.1 154.2±6.0 197.1± 5.4 225.2± 5.3 238.8± 4.0 250.5± 4.9 262.6± 5.9 262.4± 9.8 |
82.1± 2.12 159.3± 1.9 204.4±1.9 232.0± 2.7 250.0 ± 2.54 263.7± 4.3 267.0± 4.2 299.2± 5.33 |
Mean3SEM. Differences from controls have been analysed by Student’s t-test, giving the P values of footnote 2,3,4 and 5.
2P <0.005
3P < 0.025
4P < 0.01
5P < 0.05
TABLE 2
Survival and longevity of rats, days
|
No rats |
Mean age |
50% dead |
75% dead |
90% dead |
Last |
Longevity1 |
Control Male Female |
52 54 |
819 910 |
872 912 |
975 1050 |
1057 1157 |
1232 1347 |
1160 ± 27.8 1304 ± 36.0 |
Zirconium Male Female |
56 58 |
870 935 |
881 947 |
1077 1187 |
1077 1187 |
1189 1291 |
1127 ± 23.0 1247 ± 17.4 |
1Mean ± SEMof last 10% of animals surviving.
TABLE 3
Serum glucose and cholesterol levels in rats fed zirconium
|
Age (days |
Glucose (Fasting) |
Glucose (non-fasting) |
Cholesterol (mg/100ml) |
Males Control Zirconium |
718 921 |
106.5±3.62 106.1± 9.9 |
134.4± 5.1 133.3± 4.7 |
77.5± 2.1 89.7± 5.63 |
Females Control Zirconium |
698 921 |
79.6± 8.2 111.4± 5.64 |
114.2± 5.4 120.5 ± 3.3 |
116.0± 6.0 100.7± 9.0 |
2 Mean±SEM Differences from comparable controls have been analysed by Student’s t test, giving the P values of footnotes 3, 4 and 5.
3 P < 0.01.
4 P < 0.005.
5 P < 0.025.
TABLE 4
Mean heart and body weights of rats and gross tumors
|
No rats autopsied |
Weight at death (g) |
Heart weight (mg) |
Ration x 1000 HW/BW |
Tumours |
|
|
No |
% |
||||
Control Male Female |
50 39 |
334 234 |
1498 949 |
4.49 4.06 |
10 14 |
20.0 35.9 |
Zirconium Male Female |
46 53 |
324 244 |
1280 1019 |
3.95 4.18 |
7 20 |
15.2 37.7 |
TABLE 5
Zirconium in rat tissues, wet weight1
Organ/sex |
Controls2 |
Fed Zirconium3 |
Difference (µg/g) |
|||
No rats |
Mean (µg/g) |
No N.D. |
No rats |
Mean (µg/g) |
||
Males Kidney Liver Heart Lung Spleen Tumours Mean7 |
42 35 39 35 33 3 - |
10.5 10.5 7.8 6.4 3.1 2.7 7.8 |
4 3 264 3 3 1 - |
10 9 10 3 10 - - |
9.7 11.2 17.2 7.4 35.15 - 17.7 |
-0.8 +0.7 +9.4 +1.0 +32.0 - +9.9 |
Males Kidney Liver Heart Lung Spleen Tumours Mean7 |
38 38 31 38 31 3 - |
5.4 3.4 7.7 9.6 22.3 4.5 9.3 |
95 0 56 0 4 1 - |
37 35 37 37 35 - - |
12.5 6.7 9.9 10.5 19.9 - 11.9 |
+7.1 +6.3 +2.2 +0.9 -2.4 - +2.6 |
1 Tissues were pooled in groups of 2 to 16, usually 4 to 7.
2 Control rats were 144 to 900 days old.
3 Zirconium-fed rats were 427 to 1172 days old. All zirconium-fed rats had zirconium in their tissues. Limit of detection of the method was 0.01 to 0.017µg/gram wet weight. N.D., not detected.
Differences between controls and zirconium-fed rats have been treated by chi-square analysis,
resulting in the P values of footnotes 4, 5 and 6.
4 P < 0.001
5 P < 0.005
6 P < 0.05
7 Excluding tumors.
Data source
Reference
- Reference Type:
- publication
- Title:
- Zirconium, niobium, antimony, vanadium and lead in rats: life term studies.
- Author:
- Schroeder, HA; Mitchener, M; Nason, AP.
- Year:
- 1 970
- Bibliographic source:
- J Nutr 100:59−68.
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In a lifetime feeding study, the distribution of zirconium in various tissues was measured after sacrifice.
- GLP compliance:
- no
- Remarks:
- Study pre-dates the intorduction of GLP
Test material
- Reference substance name:
- Zirconium sulphate
- EC Number:
- 238-694-4
- EC Name:
- Zirconium sulphate
- Cas Number:
- 14644-61-2
- Molecular formula:
- H2O4S.1/2Zr
- IUPAC Name:
- Zirconium disulphate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Details on species / strain selection:
- BLU: (LE) strain, Blue Spruce Farms, Inc., Altamont, New York
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pregnant females were purchased from BLU: (LE) strain, Blue Spruce Farms, Inc., Altamont, New York, and the offspring were born and weaned in the study laboratory.
- Housing: 4 per cage
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- other: feed and drinking water
- Duration and frequency of treatment / exposure:
- From weaning to natural death (a maximum of 1347 days).
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.79 mg/kg bw/day
- Remarks:
- males
- Dose / conc.:
- 0.89 mg/kg bw/day
- Remarks:
- females
- No. of animals per sex per dose / concentration:
- 56 males and 58 females)
- Control animals:
- yes
- Details on study design:
- The test drinking water contained 5 ppm zirconium sulfate and the experimental rats also were fed a diet containing 2.66 μg/g zirconium. Using time-weighted average body weight and default water consumption in Long-Evans rats, the dose of 5 ppm zirconium sulfate in drinking water was converted to 0.60 mg/kg-day for males and 0.67 mg/kg-day for females. The dose of 2.66 mg/kg zirconium in feed was converted (also using time-weighted average body weights and food consumption) to 0.19 mg/kg-day for males and 0.22 mg/kg-day for females. Because the rats ingested both drinking water and feed, the doses were summed for a total equivalent dose (TED) of 0.79 mg/kg-day in males and 0.89 mg/kg-day in females.
Results and discussion
Any other information on results incl. tables
TABLE 5
Zirconium in rat tissues, wet weight1
Organ/sex |
Controls2 |
Fed Zirconium3 |
Difference (µg/g) |
|||
No rats |
Mean (µg/g) |
No N.D. |
No rats |
Mean (µg/g) |
||
Males Kidney Liver Heart Lung Spleen Tumours Mean7 |
42 35 39 35 33 3 - |
10.5 10.5 7.8 6.4 3.1 2.7 7.8 |
4 3 264 3 3 1 - |
10 9 10 3 10 - - |
9.7 11.2 17.2 7.4 35.15 - 17.7 |
-0.8 +0.7 +9.4 +1.0 +32.0 - +9.9 |
Males Kidney Liver Heart Lung Spleen Tumours Mean7 |
38 38 31 38 31 3 - |
5.4 3.4 7.7 9.6 22.3 4.5 9.3 |
95 0 56 0 4 1 - |
37 35 37 37 35 - - |
12.5 6.7 9.9 10.5 19.9 - 11.9 |
+7.1 +6.3 +2.2 +0.9 -2.4 - +2.6 |
1 Tissues were pooled in groups of 2 to 16, usually 4 to 7.
2 Control rats were 144 to 900 days old.
3 Zirconium-fed rats were 427 to 1172 days old. All zirconium-fed rats had zirconium in their tissues. Limit of detection of the method was 0.01 to 0.017µg/gram wet weight. N.D., not detected.
Differences between controls and zirconium-fed rats have been treated by chi-square analysis,
resulting in the P values of footnotes 4, 5 and 6.
4 P < 0.001
5 P < 0.005
6 P < 0.05
7 Excluding tumors.
Applicant's summary and conclusion
- Conclusions:
- In this study 5 ppm zirconium sulphate in drinking water and 2.66 μg/g zirconium in feed was adminstered to rats over a lifetime. The accumulation of zirconium in the kidney, liver, heart, lung, and spleen was examined. Accumulation in the organs was not observed, except for male rats where significant accumulation in the spleen was noted.
- Executive summary:
In this study 5 ppm zirconium sulphate in drinking water and 2.66 μg/g zirconium in feed was adminstered to rats over a lifetime. The accumulation of zirconium in the kidney, liver, heart, lung, and spleen was examined. Accumulation in the organs was not observed, except for male rats where significant accumulation in the spleen was noted.
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