Registration Dossier
Registration Dossier
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EC number: 284-892-9 | CAS number: 84989-04-8 The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic information available, no information on distribution in tissue
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Metabolism of derivatives of toluene: cresols.
- Author:
- Bray HG , WV Thorpe, K White
- Year:
- 1 950
- Bibliographic source:
- Biochem. J. 46, 275-278
- Reference Type:
- review article or handbook
- Title:
- EHC (Environmental Health Criteria) No. 168: Cresols
- Author:
- WHO
- Year:
- 1 995
- Bibliographic source:
- IPCS (International Programme on Chemical Safety) WHO, Geneva
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- Method: Single oral application by gavage, test substance dissolved in bicarbonate, urinary excretion was collected over a period of 24 hours and levels of free and conjugated cresols was estimated by the method of Folin O and Ciocalteu V (1927): J. biol Chem. 73, 627
Metabolites were measured with the method described in Bray et al 1947 Biochem j 41, 212 and Bray et al (1948) Biochem J 43, 561 - GLP compliance:
- no
Test material
- Radiolabelling:
- no
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMAL
- Weight at study initiation: 2-3 kg
-diet: rabbit pellets ad libitum
-water: ad libitum
no further data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: solution of sodium bicarbonate
- Details on exposure:
- single oral application by gavage,solvent sodium bicarbonate
- Duration and frequency of treatment / exposure:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 mg/kg bw
- No. of animals per sex per dose / concentration:
- 10
- Control animals:
- not specified
- Positive control reference chemical:
- no data
- Details on study design:
- no further data other than described under 'Principles of test method'
- Details on dosing and sampling:
- no further data other than described under 'Principles of test method'
- Statistics:
- no data
Results and discussion
- Preliminary studies:
- no data
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Within 24 hours 80% of the o-cresol doses was excreted in the urine indicating that at least this amount was absorbed through the gastrointestinal tract.
- Type:
- excretion
- Results:
- Urinary excretion was the maine route of elemination: Within 24 hours ca 80% of the o-cresol doses was excreted in the urine
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Within 24 hours 80% of the o-cresol doses was excreted in the urine indicating that at least this amount was absorbed through the gastrointestinal tract.
- Details on distribution in tissues:
- no data
Transfer into organs
- Observation:
- not determined
- Details on excretion:
- urinary excretion was the maine route of elemination:
Within 24 hours ca 80% of the o-cresol doses was excreted in the urine
excreted products: ca 15 % as ethereal sulphate, ca 72 % as ether glucuronide and ca 1% as free cresol
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- see section 'remarks on results'
Any other information on results incl. tables
RS-Freetext:
o-Cresol was excreted by the rabbit
55-91 % as ether glucuronides and
13-19 % as ethereal sulphates.
0-2 % as free cresol
75-83 % total cresol
Applicant's summary and conclusion
- Executive summary:
Single oral application by gavage of o-cresol dissolved in bicarbonate and collection of urinary excretion over a period of 24 hours showed that o-cresol was excreted mainly in the urine : 55 -91 % as ether glucuronides, 13 -19 % as ethereal sulphates and 0 -2 % as free cresol
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