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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The purity of the test substance was unknown. The number of animals, the control animals and the GLP were not mentioned. The protocol and the results were quite well described.

Data source

Reference
Reference Type:
publication
Title:
A study of the serum concentrations of ibuprofen and guaiacol in rats after administraion of ibuprofen, guaiacol and AF 2259
Author:
Catanese B., Interdonato N., Barillari G.
Year:
1979
Bibliographic source:
Boll. Chim. Farm., 118, 232-237.

Materials and methods

Objective of study:
absorption
Principles of method if other than guideline:
See details below
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The origin of guaiacol was not reported and its purity was unknown.
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Long-Evans
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 120-150 g
- Fasting period before study: no data
- Housing: standard plastic cages (590*385*420 mm)
- Individual metabolism cages: no data
- Diet: no data
- Wate: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methylcellulose
Details on exposure:
PREPARATION OF DOSING SOLUTIONS:
* Diet preparation: no data
* Vehicle
- Justification for use and choice of vehicle: most appropriate for dilution of test substance
- Concentration in vehicle: 0.5%
- Amount of vehicle: 10 ml/kg

* Homogeneity and stability of test material: no data
Duration and frequency of treatment / exposure:
single oral application
Doses / concentrations
Remarks:
Doses / Concentrations:
10.3 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
Long Evans male rats received by gavage 10.3 mg/kg bw guaiacol suspended in 0.5% methylcellulose aqueous solution.
The animals had access only to water up to their sacrifice.
They were sacrificed at 5, 10, 20, or 40 min and at 1, 2, or 4 hours after the guaiacol dose administered.
Serum samples were obtained by cutting the carotid artery under ether anaesthesia and centrifuging the blood collected in order to determine the
guaiacol concentration. After the serum was treated with trichloroacetic acid, sulfanilic mixture was added to obtain an orange colour: the solution
was read at 470 nm.
The amount of guaiacol in the serum of the treated animals was calculated using standard solution containing known quantities of guaiacol added to blank serum. The colorimetric determination of the guaiacol concentration was made in triplicate. The sensitivity of the method was 1.2 µg/mL of
serum.
A curve represented the guaiacol concentration in function of the time of sacrifice.

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
The results showed that guaiacol was rapidly absorbed: it was present in the blood already 5 min after administration.
The peak of concentration was 8.8 µg/mL being reach within 10 min.
The guaiacol disappearance from the blood was equally rapid: 4 hours after administration, no guaiacol quantities were detected in the blood.

Metabolite characterisation studies

Metabolites identified:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
Executive summary:

In a toxicokinetic study (Catanese, 1979), 10.3 mg/kg of gaiacol was administered to Long-Evans rats by gavage.

The results of this study showed that Gaiacol was rapidly absorbed after oral administration and disappeared from the blood 4 hours after administration.

This study performed in rats is classified acceptable and satisfies the guideline requirement for a toxicokinetic study.