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Administrative data

Description of key information

Acute toxicity: oral
One reliable study was available and defined an LD50 of 3500 mg/kg bw in rats for zirconium sulfate (Cochran et al., 1950).
Acute toxicity: inhalation
No study needs to be conducted as the substance is classified as corrosive to the skin.
Acute toxicity: dermal
No study needs to be conducted as the substance is classified as corrosive to the skin.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable non-GLP study reporting on the acute oral toxicity of a 25% zirconium sulfate solution. Limited information on test substance and methods employed.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult rats
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: no data
- Housing: maintained in air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
25% aqueous solutions were used.

Doses:
Single dose, no more data
No. of animals per sex per dose:
22 rats in total
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
Statistics:
The LD50 values were obtained from ten day mortality data by using the log-probability method.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 500 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 253 mg/kg bw
Based on:
element
Remarks:
Zr
Mortality:
The rats showed a progressive depression and decrease in activity until death occurred.
No sex differences were noted, and the LD50 value was therefore derived from the combined data on both sexes.
The time of death varied from a few hours to a few days after administration. Few deaths however occurred later than 5 days after administration.
Clinical signs:
No characteristic physiologic changes were observed.
Body weight:
No characteristic physiologic changes were observed.
Gross pathology:
No characteristic gross pathologic changes were observed.
Conclusions:
The acute oral LD50 in rats via gavage is 3500 mg/kg bw for zirconium sulfate.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

Cochran et al. (1950) observed an acute oral LD50 of 3500 mg/kg bw (1253 mg Zr/kg bw) when zirconium sulfate was administered by oral gavage to Sprague-Dawley rats. The time of death varied from a few hours to a few days following the exposure to the test substance. Few deaths were reported later than five days after exposure to test substance. Individual animal data were not provided. Animals exposed to the test substance showed a progressive depression and decrease in activity until death occurred. No gross pathological changes were reported in any of the animals receiving lethal doses of the test substance. No physiological changes were reported in any of the animals receiving lethal doses of the test substance. Further, the same study reported an acute oral LD50 of 10000 mg/kg bw for the related substance sodium zirconyl sulfate.

Acute inhalation toxicity

An acute inhalation study does not need to be conducted as the substance is classified as corrosive to the skin (according to REACH Annex VIII section 8.5, column 2).

Acute toxicity: dermal

An acute dermal study does not need to be conducted as the substance is classified as corrosive to the skin (according to REACH Annex VIII section 8.5, column 2).

Acute toxicity: other routes

Cochran et al. (1950) observed an acute LD50 of 175 mg/kg bw and 4100 mg/kg bw when zirconium sulfate and

sodium zirconyl sulfate, respectively, were administered to rats by intraperitoneal injection. These studies were considered as supporting studies only, since intraperitoneal injection is not a normal exposure pathway and absorption of zirconium via realistic pathways (oral, dermal, inhalation) is expected to be extremely low.


Justification for selection of acute toxicity – oral endpoint
One reliable study available for zirconium sulfate.

Justification for classification or non-classification

Based on the available data and according to the DSD/CLP criteria zirconium sulfate should not be classified for acute toxicity via the oral route of exposure.