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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

basic toxicokinetics in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
The target substance is hydrolytically unstable with hydrolysis half-life less than 5 minutes. The hydrolysis products have been identified to be 1-butanol and hydrated zirconium dioxide. The properties and toxiciteis of the hydrolysis products are therefore used for read-across.
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Objective of study:
no guideline followed
Principles of method if other than guideline:
n-[1-14C]Butanol was mixed with corn oil and administered by gavage to male Charles River CD (SD) rats in doses of 4.5, 45, or 450 mg/kg bw. The excretion of the n-[1-14C]Butanol was examined.
GLP compliance:
not specified
Route of administration:
oral: gavage
corn oil
Dose / conc.:
4.5 mg/kg bw (total dose)
Dose / conc.:
45 mg/kg bw (total dose)
Dose / conc.:
450 mg/kg bw (total dose)
No. of animals per sex per dose / concentration:
not specified.
highest concentrations: liver 3.88 % at 8 h, blood 0.74 % at 8 h, kidney 0.24 % at 4 h, other tissue < 0.12 %
Elimination of administered dose 450 mg/kg bw: > 44 % within 4 h, 69.3 % at 8 h, 83.3 % at 24 h
other: remaining radioactivity in carcass
at 4 h: 42.2 %; at 8 h: 27.2 %; at 24 h: 12.3 %
Metabolites identified:
Details on metabolites:
About 75 % of the radioactivity was detected as 1-butanol, presumably both as an O-sulfate (44.4 %) and as an O-glucuronide (30.7 %). Urea accounted for the remainder of the radioactivity.
no bioaccumulation potential based on study results

Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

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. The hydrolysis products include 1-butanol and non-hazardous zirconium dioxide. This information is used as a supporting evidence on the toxicity of the target substance in CSA.


1-butanol is readily absorbed through the skin, intestinal tract, and lungs (Sander, 1933; Theorell and Bonnichsen, 1951; Winer, 1958; Merritt and Tomkins, 1959; Wartburg et al., 1964) and is eliminated after metabolism primarily by alcohol and aldehyde dehydrogenases. Two hours after rats (strain not specified) were given an oral dose of 2,000 mg/kg body weight, the maximum blood-alcohol concentration was 500 mg/l (Gaillard and Derache, 1965). After four hours, the concentration dropped to 150 mg/l, and only 0.03% of the administered dose was excreted in the urine after eight hours.

In another study, CD rats excreted 83.3% of the dose (450 mg/kg body mass) as carbon dioxide and 4.4% in the urine after 24 hours (DiVincenzo and Hamilton, 1979). Beagle dogs dermally exposed through an absorption cell on the thorax absorbed the compound at a rate of 8.8 mg/min per cm 2 over a 60-minute period (DiVincenzo and Hamilton, 1979). In an inhalation study, beagle dogs exposed to 50 ppm BA over a 6-hour period absorbed approximately 55% of the inhaled vapor (DiVincenzo and Hamilton, 1979). (Adapted from UNEP 2004).


Overall, 1-butanol is rapidly absorbed, metabolized, and excreted in rats. Accumulation of n-butanol or its metabolites is unlikely to occur.