Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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-propanol and zirconium dioxide. The discussion of toxiciy is based on the hydrolysis/degradation products.
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-propanol is the main hydrolysis prodcuts of the target substance. Properties of the the hydrolysis substance are used for read-across.
Qualifier:
according to
Guideline:
other: other
Principles of method if other than guideline:
Group of 5 male and 5 female rats (180-350 g) per dose level were administered the test substance by stomach tube. The rats were fasted 18 hr before administration. The rats were observed until the survivors had returned to normal in appearance and weight.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
No. of animals per sex per dose:
5
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 6 500 mg/kg bw
Based on:
test mat.
Mortality:
Mortality occured within 2 - 18 hr after administration.
Body weight:
Weight loss observed.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 on rats was 6500 mg/kg bw. GHS criteria was not met for acute oral toxicity.
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:
6 500 mg/kg bw

Acute toxicity: via inhalation route

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Reference
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-propanol and zirconium dioxide. The discussion of toxiciy is based on the hydrolysis/degradation products.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
47 000 mg/m³

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

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-propanol and zirconium dioxide. The discussion of toxiciy is based on the hydrolysis/degradation products.
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:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24h
No. of animals per sex per dose:
4
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 4 032 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 4032 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:
4 032 mg/kg bw

Additional information

Justification for classification or non-classification