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Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
prior to GLP, no data on purity

Data source

Reference Type:
Vertraeglichkeit und Ausscheidungsverhaeltmisse von Dicarbonsaeure
Enders A.
Bibliographic source:
Naunyn-Schmiedberg's Archiv für experimentelle Pathologie und Pharmakologie, 197, 597-610

Materials and methods

Objective of study:
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sebacic acid
EC Number:
EC Name:
Sebacic acid
Cas Number:
Molecular formula:
sebacic acid

Test animals

not specified
not specified
Details on test animals or test system and environmental conditions:
- 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
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
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

Applicant's summary and conclusion