Registration Dossier
Registration Dossier
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EC number: 226-408-0 | CAS number: 5395-50-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2013
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Human Health Tier II Assessment For N-Methylol imidazolidones
- Author:
- Accelerated Assessment of Industrial Chemicals in Australia (IMAP)
- Bibliographic source:
- https://www.nicnas.gov.au/chemical-information/imap-assessments
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- - Principle of test: oral absorption study, gavage
- Short description of test conditions: rats were dosed ad 200 mg/kg bw and 100 mg/kg bw oral by gavage with the test substance
- Parameters analysed / observed: oral absorption, tissue distribution, urinanalysis - GLP compliance:
- not specified
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- rats dosed at 200 mg/kg bw and 1000 mg/kg bw of the test substance by oral gavage
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/kg bw (total dose)
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- Control animals:
- not specified
- Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, other tissues
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- 22 %
Applicant's summary and conclusion
- Conclusions:
- The animals dosed at 200 mg/kg bw and 1000 mg/kg bw of the test substance by oral gavage in an oral absorption study absorbed 22 % of the dose.
- Executive summary:
Oral absorption of the test substance was found to be low. In an oral absorption study, rats dosed at 200 mg/kg bw and 1000 mg/kg bw of the test substance by oral gavage absorbed 22 % of the dose, with the largest portion of the chemical recovered in faeces (78 %). Only 2 - 9 % of the chemical was recovered in urine during the week following administration. Tissue distribution studies confirmed that the oral absorption of the chemical was low.
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