Registration Dossier
Registration Dossier
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EC number: 401-990-0 | CAS number: 106990-43-6 CHIMASSORB 119; LOWILITE 19
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration and frequency of treatment / exposure:
- a single dose via oral gavage
Doses / concentrations
- Remarks:
- Doses / Concentrations:
- ca. 50 mg/kg bw
- ca. 1000 mg/kg bw
- No. of animals per sex per dose / concentration:
- 4 male animals per dose
- Control animals:
- not specified
Results and discussion
- Preliminary studies:
- no data
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- no data
- Details on distribution in tissues:
- There is hardly any retention of radioactivity in tissues.
- Details on excretion:
- After oral dose of 50 and 1000 mg of the substance per kg body weight, the excretion of total radioactivity in virtually complete within 96 hours after administration. Radioactivity is excreted nearly entirely via faeces (96-99% of recovered radiolabel). Renal excretion is very low (0.28-0.60% of the dose), and excretion of radioactivity via expired air negligible (<=0.01% of the dose).
Metabolite characterisation studies
- Metabolites identified:
- not specified
- Details on metabolites:
- no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
There was no significant bioconcentration or accumulation in any of the organs investigated.
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