Zirconium dichloride oxide

Endpoint summary

Description of key information

Acute toxicity: oral
One reliable study was available which determined a LD50 of 3500 mg/kg bw in rats (Cochran et al., 1950).
Acute toxicity: inhalation
No study required. In addition the substance is corrosive.
Acute toxicity: dermal
No study needs to be conducted as the substance is skin corrosive.
Acute toxicity: other routes
One reliable study was available for the intraperitoneal route of exposure and determined a LD50 of 400 mg/kg bw (Cochran et al., 1950).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Well documented, scientifically sound study according to a method similar to OECD 401 "Acute Oral Toxicity" with the following deviations: (1) The number of deaths at each dose were not reported; (2) the specific doses (mg/kg) were not provided; (3) individual clinical observations, body weights, pathology were not reported; (4) sex of the animals was not provided.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

see rationale for reliability

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Adults
- Weight at study initiation: 200 - 300 g
- Diet (e.g. ad libitum): ad libitum, purina chow
- Water (e.g. ad libitum): ad libitum
- Fasting period before study: no data
- Housing: maintained in air-conditioned rooms

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

Doses:

Specific doses administered were not provided

No. of animals per sex per dose:

22 rats were used (sex of the animals was not provided)

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 10 days, an initial group of animals receiving the test subsance was kept for 30 days to verify if any significant mortality occurred after the tenth day.

Statistics:

The LD50 values were obtained from 10-day mortality data by using the log-probability method.

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 3 500 other: mg/kg bw

Based on:

test mat.

Mortality:

The LD50 was calculated to be 3500 mg compound/kg (990 mg metal/kg). 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.

Clinical signs:

other: Animals exposed to the test substance showed a progressive depression and decrease in activity until death occurred.

Gross pathology:

No gross pathological changes were reported in any of the animals receiving lethal doses of the test substance.

Other findings:

No physiologic changes were reported in any of the animals receiving lethal doses of the test substance.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 in rats via gavage was calculated to be 3500 mg/kg bw for zirconium dichloride oxide.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

A reliabiliy score of Klimisch 3 was assigned because 1. the tested concentrations are not clearly reported; 2. there is no guideline reported; 3. no data on substance origin and purity are given; 4. no data on origin of animals and acclimation period for animals are reported; 5. no data on controls is given.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Single administration of product diluted in distilled water to mice.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

mouse

Strain:

Swiss

Sex:

female

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Dilution in water (50%)

No. of animals per sex per dose:

24 animals were used (female)

Control animals:

not specified

Sex:

female

Dose descriptor:

LD50

Effect level:

4 330 mg/kg bw

Based on:

test mat.

Some animals died during the 24 hours following administration. For the survivors, the behavior is characterized by inappetence, progressive emaciation, prostrate animal, dull coat. At autopsy often gastrointestinal necrosis and sometimes lung necrosis are found.

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 was calculated according to the Bliss method to be 4330 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 500 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity

Cochran et al. (1950) observed an acute oral LD50 of 3500 mg compound/kg bw for zirconium dichloride oxide in 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. This study was considered reliable with restrictions (Klimisch 2) and was selected as key study to cover the endpoint. The results from this study are supported by a non-reliable (Klimisch 3) study from Delongeas et al. (1983) reporting a LD50 of 4330 mg/kg bw for mice.

Acute inhalation toxicity

An acute inhalation study does not need to be conducted as the substance is classified as corrosive to skin (according to REACH Annex VIII section 8.5, column 2). In addition, there is sufficient evidence available indicating that zirconium is barely absorbed after exposure via inhalation (see section 7.1) and is therefore of low bioavailability.

Acute toxicity: dermal

An acute dermal toxicity study does not need to be conducted as the substance is classified as corrosive to skin (according to REACH Annex VIII section 8.5, column 2). Furthermore the dermal route of exposure is not the most appropriate route as exposure via inhalation is more likely and there is no indication from the physicochemical properties of significant absorption through the intact skin.

Acute toxicity: other routes

Cochran et al. (1950) observed an acute LD50 of 400 mg compound/kg bw in Sprague-Dawley rats after intraperitoneal injection.

Justification for classification or non-classification

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