Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Exposure to butyl alcohol. Uptake and distribution in man
Author:
Astrand I. et al.
Year:
1976
Bibliographic source:
Scand. J. Work Environ. Health 3: 165-175, 1976; cited in ECETOC JACC, n-Butanol, 2003
Reference Type:
secondary source
Title:
No information
Author:
Astrand I. et al.
Year:
1976
Bibliographic source:
cited in OECD SIDS n-Butyl Alcohol, Sept. 2001

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
Two groups of volunteers were exposed intermittently, through a breathing valve and mouthpiece, to concentrations of 100 or 200 ppm nBA
(300 or 600 mg/m3). Initial exposure (30 min at rest) was followed by a pause of 20 minutes. Three subsequent exposures (3 x 30 min) were combined with physical exercises of 50, 100 and 150 W (light, moderate and heavy) in the low exposure (100 ppm) group, and 50 W each in the high exposure (200 ppm) group.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
not specified
Subjects:
Two groups of 6 healthy male volunteers (21 - 34 years of age) were exposed intermittently,
through a breathing valve and mouthpiece.
Route of exposure:
inhalation
Reason of exposure:
intentional

Results and discussion

Any other information on results incl. tables

No significant EGG changes were recorded in any subject from either group, either at rest or during the exercises.

In the 100 ppm group, the uptake of nBA during initial exposure at rest was 43 mg of nBA, which corresponded to 48% of the dose applied. During the 3 subsequent exercises of 50, 100 and 150 W the uptake was 80, 130 and 135 mg nBA, i.e. 37, 40 and 41% of

the dose. Arterial blood concentrations in the 100 ppm group increased from 0.3 mg nBA/l at rest to 0.6, 0.9, and 1.3 mg/l during the respective exercises. Following initial exposure to 200 ppm, about 80 mg of nBA (47% of the dose applied) was taken up. The

uptake during the 3 subsequent exposures to 200 ppm with light exercise was 145 - 160 mg nBA, corresponding to 36 - 39% of the dose. In the 200 ppm group, arterial blood concentrations rose from 0.5 mg nBA /l at rest, to a plateau of 1.1 mg/l.

Applicant's summary and conclusion