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Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

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Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
According to hydrolysis test results, the hydrolysis rate is estimated to be within several minutes. The hydrolysis products have been identified to be 1-butanol and zirconium dioxide. The reproduction toxicity of the hydrolysis products were used for read-across.
Endpoint:
fertility, other
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:
Male SD rats (18/group) were exposed to concentration of 0, 3000, 6000 ppm 1-butanol for 6 weeks. The males were then mated to non-exposed females.
Separate groups of 15 pregnant females were exposed to the same concentrations from day 1 to 20 of gestation, and were allowed to deliver.
GLP compliance:
no
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
inhalation
Type of inhalation exposure (if applicable):
not specified
Vehicle:
air
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
male: 6 weeks before mating
female: day 1 - 20 of gestation
Frequency of treatment:
7 h/day
Dose / conc.:
0 ppm
Dose / conc.:
3 000 ppm
Dose / conc.:
6 000 ppm
No. of animals per sex per dose:
female 15; male 18
Control animals:
yes
Reproductive function: oestrous cycle:
no effects observed
Key result
Dose descriptor:
NOAEC
Effect level:
ca. 6 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: pregnancy rate
Key result
Dose descriptor:
NOAEC
Generation:
F1
Effect level:
ca. 6 000 ppm
Based on:
test mat.
Sex:
male/female
Basis for effect level:
developmental neurotoxicity
Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
6 000 ppm
Treatment related:
no
Conclusions:
The NOAEL for maternal and paternal animals, and their offspring was 6000 ppm (18189 mg/m3)
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
18 189 mg/m³
Study duration:
subacute
Species:
rat
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

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

No detectable effect on pregnancy rate was found for Sprague-Dawley rats for females (15/group) exposed throughout gestation or males (18) exposed for six weeks prior to mating unexposed females for inhalation exposure levels of 3,000 or 6,000 ppm 1-butanol (Nelson et al., 1989).

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the studies, there's no adverse effect on reproduction observed. Therefore, there is no need for classification as reproductive toxicity according to CLP Regulation.