Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Referenceopen allclose all

Endpoint:
chronic 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 toxicity is based on the hydrolysis/degradation products.
Endpoint:
chronic 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
Qualifier:
according to
Guideline:
other: other
Principles of method if other than guideline:
single dose
GLP compliance:
not specified
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male
Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 months
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
ca. 3 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
clinical signs
Key result
Critical effects observed:
no
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
3 000 mg/kg bw/day
Study duration:
chronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

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Referenceopen allclose all

Endpoint:
short-term repeated dose 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 toxicity is based on the hydrolysis/degradation products.
Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Remarks:
authority reviewed.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
Principles of method if other than guideline:
Study followed intent of OECD 412 with only 9 exposures in 12 days.
GLP compliance:
not specified
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
6 hr/day, 4 days/week up to 2 weeks. (9 exposure days)
Dose / conc.:
246 mg/m³ air
Dose / conc.:
1 230 mg/m³ air
Dose / conc.:
2 460 mg/m³ air
Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
slightly swollen periocular tissue, and minimal perinasal and periocular encrustations in the 1000 ppm (2460 mg/m3) exposure concentration group
Key result
Dose descriptor:
NOAEC
Effect level:
ca. 1 230 mg/m³ air
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
1 230 mg/m³
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose 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 toxicity is based on the hydrolysis/degradation products.
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No studies were conducted on the target substance, zirconium tetrapropanolate. As the target substance hydrolyses rapidly (half-life < 5 minutes) the intrinsic properties are related to hydrolysis products of the target substance, 1 -propanol.

Oral

In a limited repeated dose study, male rats were administered a nominal dose of 3000 mg/kg 1-proapnol for 4 months. Investigated parameters were restricted to body weight, food- and water consumption and alcohol uptake as well as liver weight and histology. Neither inflammation nor cirrhosis was seen in any of the livers. Thus, the dose of 3000 mg/kg bw/day is considered as NOAEL. (Hillbom et al. 1974)

 

Inhalation

Rats were exposed to 246, 1260 and 2460 mg/m3 for 6 hours/day 5 resp. 4 days/week up to 2 weeks (9 exposure days). No mortalities occur during this study. Exposure-related clinical observations were limited to slightly swollen periocular tissue, and minimal perinasal and periocular encrustations in the 1000 ppm exposure concentration group (Bushy Run 1992). A NOAEC of 500 ppm (1230 mg/m3) for irritative effects can be derived from limited studies described.

 

(cited from European Union Risk Assessment Report, propan-1-ol, 2008)

Dermal

There is no available studies on repeated dermal effects.

Justification for classification or non-classification

Based on the NOAEL (oral) and NOAEC (inhalation) 1 -propanol, there is no need for classification of the target substance in accordance with the criteria of CLP Regulation.