Zirconium tetrabutanolate

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 5 minutes. The hydrolysis products have been identified to be 1-butanol and zirconium dioxide. The discussion of toxiciy is based on the hydrolysis/degradation products.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

1-butanol is the main hydrolysis prodcuts of the target substance. Properties of the the hydrolysis substance are used for read-across.

Qualifier:

according to guideline

Guideline:

other: other

Principles of method if other than guideline:

Groups of 10 young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hours prior to treatment with different doses of the test substance. Doses are not reported, no data on preparation of dosing solutions, no data on body weight gains etc., no data on necropsies.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

not specified

No. of animals per sex per dose:

5

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 510 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 220 - <= 2 840

Mortality:

Mortality occured 4-18 hours after dosing, no further data

Clinical signs:

other: depression, coma

Gross pathology:

not reported

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The oral LD50 on rats was 2510 mg/kg bw. Meet acute oral toxicity category 5 according to GHS.

Executive summary:

As the target substance hydrolyses rapidly (half-life < 5 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 510 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 5 minutes. The hydrolysis products have been identified to be 1-butanol and zirconium dioxide. The discussion of toxiciy is based on the hydrolysis/degradation products.

Reference 2

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

other: other

Principles of method if other than guideline:

disturbance of rotarod performance

GLP compliance:

not specified

Test type:

other: reduction in respiratory rate

Species:

rat

Strain:

Wistar

Sex:

male

Route of administration:

inhalation: vapour

Vehicle:

air

Duration of exposure:

ca. 4 h

No. of animals per sex per dose:

10 male rats per group

Control animals:

yes

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

ca. 6 531 ppm

Based on:

other: rotarod performance

Exp. duration:

4 h

Interpretation of results:

GHS criteria not met

Conclusions:

pratically non toxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

6 531 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 5 minutes. The hydrolysis products have been identified to be 1-butanol and zirconium dioxide. The discussion of toxiciy is based on the hydrolysis/degradation products.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Qualifier:

according to guideline

Guideline:

other: other

Principles of method if other than guideline:

other

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

72h

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 5 300 mg/kg bw

Based on:

test mat.

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 4 200 mg/kg bw

Based on:

test mat.

Mortality:

0

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The dermal LD50 on rabbits was greater than 4200 mg/kg bw

Executive summary:

As the target substance hydrolyses rapidly (half-life < 5 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 200 mg/kg bw

Additional information

As the target substance hydrolyses rapidly (half-life < 5 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.

The acute toxicity of 1-butanol was investigated by the oral, dermal and inhalation route, respectively.

 

Oral

Oral LD50 values for BA in experiments in rats range from 790 to 4,360 mg/kg (Union Carbide Corporation, 1951, 1966; Jenner, 1964; Purchase, 1969). The difference in values between the three key studies (Union Carbide Corporation, 1951, 1966, Jenner 1964) is most likely due to strain differences.

 

Inhalation

In 4-hour exposures, an inhalation EC50 value of 6,530 ppm was observed for disturbance of rotarod performance by male Wistar rats and an inhalation ED50 value (concentration for 50% reduction in respiratory rate) of 3,010 ppm was observed for mice (Korsak et al., 1993). Available information suggests that the acute toxicity (central nervous system or CNS effects) of BA is moderate in several animal species (Patty, 1982).

 

Dermal

Dermal LD50 values of 5300 and 4200 mg/kg (Row and McCollister, 1982) were observed for rabbits.

(cited from UNEP 2004)

Justification for classification or non-classification

As the intrinsic properties of the target substance are related to the decomposition product 1-butanol, there is no need to classify the target substance as acute toxic according to CLP Regulation 1272/2008.