Reaction mass of (2-methoxymethylethoxy)propanol and [2-(2-methoxymethylethoxy)methylethoxy]propanol and sodium methanolate

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:

1985

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.