Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study applied standard methodology and was conducted under the GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
Rat liver homogenate enzymes were used to follow the in vitro metabolism of vinyl neononanoate and establish the Michaelis-Menton first-oeder rate constant (Km) and maxium velocity (Vmax).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
not specified
Details on test animals and environmental conditions:
The Fisher 344 rats were obtaiined from Harlan Sprague Dawley at 8 9 weeks of age. All animals were assigned unique numbers and identified by ear tags. The animals were individually housed in stainless steel, wire mesh cages. DACB® (Deotized Animal Cage Board; Shepherd Specialty Papers, Inc.) was placed under each cage and changed regularly. An automatic timer was set to provide fluorescent lighting for a 12—hour photoperiod (approximately 0500 to 1700 hours for the light phase). Temperature and relative humidity were recorded (Cole—Parmer Rygrothermograph® Seven—Day Continuous Recorder, Model No. 8368—00, Cole—Parmer Instrument Co., Chicago, IL). Temperature was routinely maintained at 66—77°F; relative humidity was routinely maintained at 40—70%. Tap water (Municipal Authority of Westmoreland County, Greensburg, PA) was available ad libitum and was delivered by an automatic watering system with demand control valves mounted on each rack. Water analyses were provided by the supplier, Halliburton NUS Environmental Laboratories, Materials Engineering & Testing Company, and Lancaster Laboratories, Inc. at regular intervals. EPA standards for maximum levels of contaminants were not exceeded. Pelleted, certified AGWAY® PROLAB® Animal Diet Rat, Mouse, Hamster 3000 (Agway Inc.), was available ad libitum.

Administration / exposure

Route of administration:
other: in vitro liver homogenate
Vehicle:
other: Methanol
Details on exposure:
Vinyl neonononoate was incubated in 3% rat liver homogenate in phosphate buffer (pH 7.4) at 37 degrees C for one minute to establish metabloism kinetics.
Duration and frequency of treatment / exposure:
In vitro exposure was for one minute
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1, 2.5, 5 7.5 and 15 mM.
No. of animals per sex per dose:
No animals exposed, treatment was in vitro.
Positive control:
None
Details on study design:
Metabloism rate was established by following the rate of parent substance disappearance.
Details on dosing and sampling:
Dosing was in vitro in 3% rat liver homogenate with one sampling time at approximately one minute.
Statistics:
Various.

Results and discussion

Metabolite characterisation studies

Metabolites identified:
no

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: metabolism rates
The Km (mM) for vinyl neononanoate in vitro was 27 and the Vmax (umoles/mg protein/min.) was 0.470. Assessment of several vinyl esters demonstrated that chain length and branching impacted in vitro metabolism rate.
Executive summary:

In vitro metabolism in 3% rat liver homogenate was established fore vinyl neononanoate by follwing the dissappearance of the parent substance. The Km (mM) for vinyl neononanoate in vitro was 27 and the Vmax (umoles/mg protein/min.) was 0.470.