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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:
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:
1986

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:
other: Annex V
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Details of label: 14C-labelled substance. Label is in the phenolic ring.
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:
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.