Butan-1-ol

Dermal absorption

Administrative data

Endpoint:

dermal absorption in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Fate of n-Butanol in rats after oral administration and its uptake by dogs after inhalation or skin application

Author:

DiVincenzo GD, Hamilton ML

Year:

1979

Bibliographic source:

Toxicology and applied Pharmacology 48: 317-325

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Dogs were exposed to n-[1-14C]Butanol dermally for 60 minutes. Breath and urine was collected for 8 hours. The dermal absorption and also the excretion of butanol was determined.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Butan-1-ol

EC Number:

200-751-6

EC Name:

Butan-1-ol

Cas Number:

71-36-3

Molecular formula:

C4H10O

IUPAC Name:

butan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): n-[1-14C]butanol
- Specific activity (if radiolabelling): 1.71 mCi/mmol
- Locations of the label (if radiolabelling): n-[1-14C]butanol

Radiolabelling:

yes

Remarks:

14C

Test animals

Species:

dog

Strain:

Beagle

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Marshall Research Animals, Inc. Noth Rose, NY, USA

Administration / exposure

Type of coverage:

not specified

Vehicle:

other: unspecified carrier

Duration of exposure:

60 min

Doses:

20 µCi n-[1-14C]butanol in carrier

No. of animals per group:

2 males

Control animals:

no

Details on study design:

APPLICATION OF DOSE: 20 µCi n-[1-14C]butanol in 15 mL carrier

TEST SITE
- Preparation of test site: hair was clipped 24 h before application
- Area of exposure: ca. 55.6 cm2 on thorax
- Type of cover / wrap used: A sealed glass absorption cell which was secured with surgical adhesive and tape was used. Cotton gauze was placed inside the cell to facilitate the uniform distribution of solvent over the surface of the skin.

SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: Yes, animals were anesthetized with sodium pentobarbital. Atropine sulfate was given as preanesthetic.

SAMPLE COLLECTION
- Collection of urine: continuously by an urethral catheter
- Collection of expired air: continuously in a Saran bag by means of an oral endotracheal tube connected to a two-way valve. The contents of the Saran bag were passed through a silica gel trap to adsorb unchanged n-[14C]butanol and through a sodium hydroxide trap to collect 14CO2.

Radioactivity excreted in the breath and urine from a skin exposure was compared to the excretion of radioactivity by dogs dosed intravenously with 1 mg/kg n-[1-14C]butanol.

Results and discussion

Signs and symptoms of toxicity:

not specified

Dermal irritation:

not specified

Absorption in different matrices:

The elimination of radioactivity after the application of n-[1-14C]butanol to the skin of two male beagle dogs was examined. After 60 min, 29 mg of n-butanol was absorbed through the skin of each dog. The absorption rate was 8.8 µg/min/cm2. The excretion of radioactivity was ca. 15 dpm in breath and ca. 3 dpm in urine.
Skin absorption calculations were based on the 8-hr excretion of radioactivity in the breath and urine of dogs dosed intravenously with n-[1-14C]butanol (1 mg/kg bw). For those animals the elimination is expressed as a percentage of the administered dose. About 15 % of the dose was eliminated in the breath as 14CO2 and 2.7 % was excreted in the urine. There was no unchanged n-butanol detected in the breath. The 8-hr elimination of radioactivity in the breath and urine averaged about 17 % of the administered dose.
The assumption was made that the metabolic fate and disposition of n-[14C]butanol is identical after iv or skin administrations.

Percutaneous absorption

Percutaneous absorption 1

Key result

Time point:

60 min

Parameter:

amount

Absorption:

29 other: mg

Percutaneous absorption 2

Key result

Time point:

60 min

Parameter:

rate

Absorption:

8.8 other: µg/min/cm2