Registration Dossier
Registration Dossier
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EC number: 400-820-2 | CAS number: 84268-33-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Objective of study:
- other: To investigate absorption, distribution and excretion of the test substance after a single oral (gavage) dose.
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
- Details on test material:
- Details of label: 14C-labelled substance. Label is in the phenolic ring.
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Suspension in a mixture of acetone, Cremphor and 0.9% NaCl.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1 mg/kg bw and 10 mg/kg bw
- No. of animals per sex per dose / concentration:
- Male: 5 animals at 1 mg/kg bw
Male: 5 animals at 10 mg/kg bw
Female: 5 animals at 1 mg/kg bw
Female: 5 animals at 10 mg/kg bw - Control animals:
- not specified
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- not specified
Any other information on results incl. tables
Very similar excretion patterns were observed in both sexes at both dose levels. Most of the radioactivity was rapidly recovered in the faeces (within 24 hours), and after 168 hours accounted for 92-97% of the administered dose. Urinary excretion was also rapid, being virtually complete within 24 hours. Based on urinary excretion, low but significant amounts of test substance were absorbed from the
gastro-intestinal tract (at leastabout 5-9% of administered dose). Additionally, the low or negligible levels of radioactivity found at 168 hours in organs/tissue (including liver), blood/plasma, intestinal tract and residual carcass reflect the highly efficient excretion of the test substance in both sexes at both dose levels.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no data
Results reflect the highly efficient excretion of the test substance in both sexes at both dose levels.
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