Sodium zirconium lactate

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: No clinical signs

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.