ASTM F750-87(2002)e1

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e1
Designation:F750–87 (Reapproved 2002)
Standard Practice for
Evaluating Material Extracts by Systemic Injection in the
Mouse
This standard is issued under the fixed designation F 750; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
e NOTE—Editorial changes were made throughout in June 2002.
1. Scope appropriateness of the method in view of the materials being
tested, their potential applications, and the recommendations
1.1 This practice covers a nonspecific, acute toxicity test
contained in Practice F 748.
used for detecting leachables from materials used in medical
4.3 The only limitation applicable is the extract preparation.
devices.
RefertoSections4.3and4.4ofPracticeF 619foradescription
1.2 The liquids injected in the mouse are those obtained by
of this limitation.
Practice F 619 where the extraction vehicles are saline, veg-
etable oil, or other liquids simulating human body fluids.
5. Apparatus
1.3 Two procedures are outlined: Method A for intravenous
5.1 Mice—The mice shall be albino-type, healthy and not
injection and Method B for intraperitoneal injection.
previously used, and shall weigh between 17 and 23 g.Animal
1.4 This practice is one of several developed for the
care shall be in accordance with the “Guide for Care and Use
assessment of the biocompatibility of materials. Practice F 748
of Laboratory Animals.” Age, sex, and weight shall be
may provide guidance for the selection of appropriate methods
recorded and reported.All the mice for each extraction vehicle
for testing materials for a specific application.
shall be from the same source. For each extraction vehicle, a
2. Referenced Documents minimum of ten mice are used in the test. If the results of this
first test group are inconclusive, then 20 more mice are needed
2.1 ASTM Standards:
to complete the test of one extraction vehicle for one plastic.
F 619 Practice for Extraction of Medical Plastics
5.1.1 During the test the mice shall be fed normally with
F 748 Practice for Selecting Generic Biological Test Meth-
commercially available feed and tap water.
ods for Materials and Devices
5.2 Cages—There shall be one cage for the five mice
3. Summary of Practice
exposed to one extract liquid. Each mouse in a cage shall be
uniquely identified, and this identification shall be recorded.
3.1 The extract liquid is prepared in accordance with Prac-
Male and female mice are housed separately, and their cages
tice F 619.The extraction vehicles are saline and vegetable oil,
are positioned in a manner which prevents the accidental
orotherextractionvehicles,asdescribedinPracticeF 619.The
transfer of feces or bedding from cage to cage.
extract liquid is injected into mice, and the animals are
5.3 Syringe—Sterile syringes, not greater than 3 mL in
observed at regular intervals for 72 h for reactions, survival,
volume, with a precision of 60.10 mL shall be used.
etc.
5.3.1 MethodA—Sterile needles of 25 to 27 ⁄2 gage shall be
4. Significance and Use
used.
5.3.2 Method B—Sterile needles of 21 to 26 gage shall be
4.1 This practice is intended to help assess the biocompat-
used.
ibility of materials used in medical devices. It is an acute
toxicological test designed to detect the presence of injurious
6. Sampling
leachable substances.
6.1 Sample in accordance with Practice F 619.
4.2 This practice may not be appropriate for all types of
implant applications. The user is cautioned to consider the
7. Sample and Test Specimen
7.1 General—The sample is the plastic or other material
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland exposed to the extraction procedure. As a result of the
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved Sept. 25, 1987. Published November 1987. Originally
published as F 750 – 82. Last previous edition F 750 – 82. U.S. Department of Health, Education, andWelfare,GuideforCareandUseof
Annual Book of ASTM Standards, Vol 13.01. Laboratory Animals, Publication No. NIH 78-23, Bethesda, MD, 1978.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F750
extraction in Practice F 619, for each extraction vehicle there Inject the blank extract liquid in the same way into five other
are available: (1) a sample extract liquid, and (2) a blank mice.Theuseofwarmwateroraheatlampmayhelpdilatethe
extract liquid. These extract liquids are to be injected into the tail veins for ease of injection.
test animals within 24 h of the end of the extraction procedure.
8.1.5 Observe all animals immediately after injection, again
Record storage conditions if not used immediately after prepa-
4 h after injection, and then at 24, 48, and 72 h, respectively,
ration.
after injection for symptoms of slight, moderate, or marked
7.1.1 There are usually two extract liquids (a blank and a
toxicity or death (Table 1). Record the observations. Measure
sample)preparedfromanextractionvehicle.Samplesbasedon
and record the body weights of all animals at 24, 48, and 72 h
other extraction vehicles may be available, as described in
postinjection.
Practice F 619, or as required by the standard for the medical
8.2 Method B, Intraperitoneal:
device.
8.2.1 Method B is to be used with vegetable oil and similar
7.2 Method A, Intravenous:
extraction vehicles designated for intraperitoneal injection.
7.2.1 The extract liquid is usually prepared from a saline
8.2.2 Agitate each extract liquid vigorously prior to with-
extraction vehicle. The dose of the extract liquid is 50 mL/kg
drawal of each injection dose, to ensure even distribution of
of body weight for each mouse, injected at a steady rate of not
extracted matter. If the extract liquid contains particulates,
more than 0.1 mL/s. If a hypotonic or hypertonic extract liquid
record and report observations.
is used, then the injection rate is adjusted appropriately.
7.2.2 Aqueous extract liquids shall be nominally isosmotic 8.2.3 For each extraction vehicle use ten mice, five for the
before injection. For example, sodium chloride may be added sample extr
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