Registration Dossier

Administrative data

Description of key information

Zirconium salts have been shown to be of low acute oral toxicity with indicative LD50 > 2000 mg/kg

Further animal testing on a corrosive substance is not justified

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
Acute oral toxicity tests were carried out on 4 groups of six male Wistar rats. Test material was administered as a suspension in corm oil by stomach tube. The LD50 doses were calculated from the tables published by Weil.
GLP compliance:
no
Remarks:
Study pre-dates the introduction of GLP
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Zirconium lactate
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 g
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
Oral doses of 0.75, 1.5, 3.0 and 6.0 g/kg of body weight were given as range-finding doses.
Groups of six rats were then given graduated doses of 1.25, 2.5, 5.0 and 10.0 g/kg of zirconium lactate.
No. of animals per sex per dose:
6 male rats per dose.
Control animals:
not specified
Statistics:
The LD50 doses were calculated from the tables published by Weil
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
In a study in male Wistar rats, the oral LD50 was found to be > 10 000 mg/kg bw, the maximum dose tested.
Executive summary:

Groups of male Wistar rats were administered zirconium lactate suspended in corn oil at doses of 1.25, 2.5, 5.0 and 10.0 g/kg. The oral LD50 was found to be greater than the maximum dose tested, i.e. > 10 g/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data from handbook with no method data provided.
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Route of administration:
oral: unspecified
Dose descriptor:
LD50
Remarks:
rats
Effect level:
1 688 mg/kg bw
Based on:
test mat.
Remarks:
zirconium tetrachloride
Dose descriptor:
LD50
Remarks:
mice
Effect level:
655 mg/kg bw
Based on:
test mat.
Remarks:
zirconium tetrachloride
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 for zirconium tetrachloride is reported to be 1688 mg/kg bw in rats, and 655 mg/kg bw in mice.
Executive summary:

The LD50 for zirconium tetrachloride is reported to be 1688 mg/kg bw in rats, and 655 mg/kg bw in mice.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Data from handbook with no data on method provided.
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Dose descriptor:
LD50
Effect level:
3 500 mg/kg bw
Based on:
test mat.
Remarks:
zirconium oxychloride
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of zirconium oxychloride in rats is reported to be 3500 mg/kg bw.
Executive summary:

The LD50 of zirconium oxychloride in rats is reported to be 3500 mg/kg bw.

Additional information

Justification for classification or non-classification