Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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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.
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:
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:
depression, coma
Body weight:
not reported
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

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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.
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:
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

Acute toxicity: via dermal route

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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.
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:
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.