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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Single dose
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Although performed in 1994, there is sufficient information to confirm low toxicity.
Only a single animal was used per dose level and the report does not include individual animal data.
The absences of findings concludes low toxicity with a maximum dose > 2000 mg/kg and no further animal testing can be justified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium zirconium lactate
EC Number:
239-570-2
EC Name:
Sodium zirconium lactate
Cas Number:
15529-67-6
Molecular formula:
C3H6O3xZr
IUPAC Name:
sodium zirconium lactate
Test material form:
solid
Specific details on test material used for the study:
15 - 25% solution in water and sodium chloride
This needs consideration when determining final dose received

Test animals

Species:
rat
Strain:
other: Clr, CD BR
Sex:
male
Details on test animals or test system and environmental conditions:
12 hour dark/light cycle, at ca 23 C

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Animals were dosed at concentrations of 150 mg/ml (lower doses) and 300 mg/ml (higher doses. Dose vaolume was adjusted according to the final dose and taking into account weights.
At the two highest dose levels, a second dose was needed to acheive the dose levels; this took place approximately 15 minutes after the first dose.
Doses:
670, 2300, 3400, 5000, 7500, 11000 mg/kg of the ca 25% strength solution
ca 170, 575, 1250, 1875, 2750 mg/kg
Note that in Europe this type of testing woudl be illegal as there is no justification to dose over 2000 mg/kg and to test multiple dose levels without considering a limit test.

No. of animals per sex per dose:
One male per dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality.
Clinical signs:
No clinical signs
Body weight:
Not specified
Gross pathology:
Not specified
Other findings:
No other findings reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Although only males were tested, with one animal per treatment, the absence of any adverse effects confirm low toxicity.
When combined with other data for zirconium toxicity, the metal appears to be of low acute toxicity.
No further animal testing can be justified.