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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:
key study
Study period:
1983
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 Type:
publication
Title:
The metabolic profile of sodium o-phenylphenate after subchronic oral administration to rats
Author:
Nakao K et al.
Year:
1983
Bibliographic source:
Food Chem Toxicol. 21(3):325-359

Materials and methods

Objective of study:
excretion
metabolism
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-biphenylate
EC Number:
205-055-6
EC Name:
Sodium 2-biphenylate
Cas Number:
132-27-4
Molecular formula:
C12H9NaO
IUPAC Name:
sodium 2-biphenylate
Details on test material:
Batch No.: MM-0144
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Fischer 344/DuCrj
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Inc., Kanagawa, Japan
- Age at study initiation: 4 weeks old
- Diet: ad libitum except for the time in metabolism cages
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 - 26
- Humidity (%): 50 ± 5
- Air changes (per hr): 4
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
daily for 136 days
Doses / concentrations
Dose / conc.:
2 other: % diet
Remarks:
The daily intake from the diet was estimated to be 280 mg for males and 180 mg for females according to the author
No. of animals per sex per dose / concentration:
5
Control animals:
yes, concurrent no treatment
Details on dosing and sampling:
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine, liver and kidney
- Time and frequency of sampling: urine was collected every 2 h for 6 h every day; liver and kidney were immediately removed at necropsy
- Method type(s) for identification: GC, GC-MS and HPLC

TREATMENT FOR CLEAVAGE OF CONJUGATES:
For the extraction of metabolites from the liver and kidneys, the tissue homogenate was digested with pronase and thereafter with glucuronidase

Results and discussion

Main ADME results
Type:
excretion
Results:
54.97% (± 7.98) and 39.04% (± 4.74) of the daily intake in males and females were excreted during 24 h in urine.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
High concentrations of phenolic metabolites, o-phenylphenol and 2,5-dihydroxybiphenyl, were found in the urine of rats of both sexes. Glucuronic acid conjugation was identified as the major route of OPP metabolism in rats.

Applicant's summary and conclusion

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