Sebacic acid

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1941

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Remarks:

prior to GLP, no data on purity

Data source

Reference

Reference Type:

publication

Title:

Vertraeglichkeit und Ausscheidungsverhaeltmisse von Dicarbonsaeure

Author:

Enders A.

Year:

1941

Bibliographic source:

Naunyn-Schmiedberg's Archiv für experimentelle Pathologie und Pharmakologie, 197, 597-610

Materials and methods

Objective of study:

excretion

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sebacic acid

EC Number:

203-845-5

EC Name:

Sebacic acid

Cas Number:

111-20-6

Molecular formula:

C10H18O4

IUPAC Name:

sebacic acid

Radiolabelling:

no

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 300g
- Diet: bread (60% corn flour, 30% dry-milk, 8 % dried yeast, 2% cod-liver and table salt)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on exposure:

Test substance was diluted in water. Before application, the substance were heated to 40°C to prevent precipitation which normally occured at room temperature. Control animals were administered equivalent volume of water.

Duration and frequency of treatment / exposure:

daily application for 4 weeks

Doses / concentrations

Dose / conc.:

1 010 mg/kg bw/day

No. of animals per sex per dose / concentration:

2 animals

Control animals:

other: water

Details on study design:

Urine analysis was performed according to the method described in Emmrich and Hoehne 1940.

Emmrich und Hoehne: Ber. d . mathemat.-physikal. Kl. d. Saechsichen Akademie zu Leipzig XCII. 15 .I 1940

Details on dosing and sampling:

The animals were dosed on a daily basis for 4 weeks. Urine sampling was performed accordingly:
-before feeding was commenced (5-6 days): 4 times (background)
- Week 1: 4 times
- Week 2: 3 times
- Week 3: 3 times
- Week 4: 4 times
- After termination of infusion: 4 times each on 2 days back to back

As a rule, 24h urine was collected for each animal. After collection, urine samples were adjusted to 250ml with water. 72 h after end of the substance intubation, the animals were sacrificed. The bodies of the 6 animals were minced, treated with alcohol and the water and ether soluble components quantified.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

not determined

Details on distribution in tissues:

not determined

Transfer into organs

Observation:

not determined

Details on excretion:

On the average, 62.5 % of the applied substance (Detection method does not exclude its metabolites.) was eliminated via urine per day. Within the entire feeding period, elimination of the test substance was always constant. Within 24h after termination of substance intubation, the test substance became totally eliminated. Quantification of the ether as well as water soluble rests of the bodies of sacrificed rats (after termination of substance feeding) indicated that sebacic acid did not accumulate in the bodies of the rats.

Toxicokinetic parameters

Toxicokinetic parameters:

other: not determined

Metabolite characterisation studies

Metabolites identified:

not measured