Registration Dossier
Registration Dossier
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EC number: 907-640-8 | CAS number: -
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Published article describing the metabolism and kinetics of radiolabelled DPM.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
- Objective of study:
- excretion
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- 14C-DPM 7.0 mCi/mmol (93.2% purity, secondary secondary isomer)
unlabelled DPM : 98% purity.
- Radiolabelling:
- yes
- Remarks:
- 14C-DPM
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- Single exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1289 mg/kg`
- No. of animals per sex per dose / concentration:
- 3 males
- Control animals:
- no
- Positive control reference chemical:
- Not applicable
- Details on study design:
- Expired air and excreta were monitored for 48 hours.
- Details on dosing and sampling:
- Three male rats were each given, by oral gavage, radiolabelled 14-C DPM with an activity of 5 uCi in a volume which did not exceed 0.5 mL. The dose was 1289 mg/kg DPM. Radiolabel was determined in feces, carcass, liver, kidney, blood, and brain.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- 93.8% as measured by total recovery in all tissues and expiration
- Details on distribution in tissues:
- Carcass - 2.3%
Skin - 1.3%
Liver - 0.5%
Kidney - 0.1%
Blood - 0.1%
Brain - 0.02%
Fat - not detected
- Details on excretion:
- 60% excreted via urine, and 27% via exhalation by 48 hours.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- * Sulfate conjugate
* Glucuronide conjugate
* Propylene glycol
* Dipropylene glycol and propylene glycol monomethyl ether (PM)
* DPM (2 isomers)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Radiolabelled DPM was readily excreted via urine and expired air following a single bolus oral dose. A number of metabolites were formed. - Executive summary:
Radiolabelled 14 -C DPM was administered by oral gavage to three male rats at a dose of 1289 mg/kg. Expired air and excreta were monitored for 48 hours for residues. DPM was well absorbed (93.8%) by gavage, and 87% was excreted via urine or expired air in the form of several main metabolites and sulfate and glucuronide conjugates by 48 hours.
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