Registration Dossier
Registration Dossier
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EC number: 205-055-6 | CAS number: 132-27-4
Basic toxicokinetics
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:
- 1 983
- Bibliographic source:
- Food Chem Toxicol. 21(3):325-359
Materials and methods
- Objective of study:
- excretion
- metabolism
- GLP compliance:
- no
Test material
- 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-phenylphenolate
- Details on test material:
- Batch No.: MM-0144
Constituent 1
- 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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