Zirconium tetrabutanolate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records

Reference

Reference 1

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.

Reference 2

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

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.