ASTM F750-87(2007)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F750–87 (Reapproved 2007)
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.
1. Scope 4.2 This practice may not be appropriate for all types of
implant applications. The user is cautioned to consider the
1.1 This practice covers a nonspecific, acute toxicity test
appropriateness of the method in view of the materials being
used for detecting leachables from materials used in medical
tested, their potential applications, and the recommendations
devices.
contained in Practice F 748.
1.2 The liquids injected in the mouse are those obtained by
4.3 The only limitation applicable is the extract preparation.
Practice F 619 where the extraction vehicles are saline, veg-
RefertoSections4.3and4.4ofPracticeF 619foradescription
etable oil, or other liquids simulating human body fluids.
of this limitation.
1.3 Two procedures are outlined: MethodAfor intravenous
injection and Method B for intraperitoneal injection.
5. Apparatus
1.4 This practice is one of several developed for the
5.1 Mice—The mice shall be albino-type, healthy and not
assessment of the biocompatibility of materials. Practice F 748
previously used, and shall weigh between 17 and 23 g.Animal
may provide guidance for the selection of appropriate methods
care shall be in accordance with the “Guide for Care and Use
for testing materials for a specific application.
of Laboratory Animals.” Age, sex, and weight shall be
2. Referenced Documents recorded and reported.All the mice for each extraction vehicle
shall be from the same source. For each extraction vehicle, a
2.1 ASTM Standards:
minimum of ten mice are used in the test. If the results of this
F 619 Practice for Extraction of Medical Plastics
first test group are inconclusive, then 20 more mice are needed
F 748 Practice for Selecting Generic Biological Test Meth-
to complete the test of one extraction vehicle for one plastic.
ods for Materials and Devices
5.1.1 During the test the mice shall be fed normally with
3. Summary of Practice
commercially available feed and tap water.
5.2 Cages—There shall be one cage for the five mice
3.1 The extract liquid is prepared in accordance with Prac-
exposed to one extract liquid. Each mouse in a cage shall be
tice F 619.The extraction vehicles are saline and vegetable oil,
uniquely identified, and this identification shall be recorded.
orotherextractionvehicles,asdescribedinPracticeF 619.The
Male and female mice are housed separately, and their cages
extract liquid is injected into mice, and the animals are
are positioned in a manner which prevents the accidental
observed at regular intervals for 72 h for reactions, survival,
transfer of feces or bedding from cage to cage.
etc.
5.3 Syringe—Sterile syringes, not greater than 3 mL in
4. Significance and Use
volume, with a precision of 60.10 mL shall be used.
5.3.1 MethodA—Sterile needles of 25 to 27 ⁄2 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
5.3.2 Method B—Sterile needles of 21 to 26 gage shall be
toxicological test designed to detect the presence of injurious
used.
leachable substances.
6. Sampling
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
6.1 Sample in accordance with Practice F 619.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved Feb. 1, 2007. Published February 2007. Originally
e1
approved in 1982. Last previous edition approved in 2002 as F 750 – 87 (2002) .
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on U.S. Department of Health, Education, andWelfare,GuideforCareandUseof
the ASTM website. Laboratory Animals, Publication No. NIH 78-23, Bethesda, MD, 1978.
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F750–87 (2007)
7. Sample and Test Specimen Weigh all mice, and record their weights. Use a system of
marking to identify each individual mouse within each group
7.1 General—The sample is the plastic or other material
of five.
exposed to the extraction procedure. As a result of the
extraction in Practice F 619, for each extraction vehicle there 8.1.4 Inject the predetermined amount (see 7.2.1)ofthe
are available: (1) a sample extract liquid, and (2) a blank
sample extract liquid into the tail vein of each of the five mice.
extract liquid. These extract liquids are to be injected into the
Inject the blank extract liquid in the same way into five other
test animals within 24 h of the end of the extraction procedure.
mice.Theuseofwarmwateroraheatlampmayhelpdilatethe
Record storage conditions if not used immediately after prepa-
tail veins for ease of injection.
ration.
8.1.5 Observe all animals immediately after injection, again
7.1.1 There are usually two extract liquids (a blank and a
4 h after injection, and then at 24, 48, and 72 h, respectively,
sample)preparedfromanextractionvehicle.Samplesbasedon
after injection for symptoms of slight, moderate, or marked
other extraction vehicles may be available, as described in
toxicity or death (Table 1). Record the observations. Measure
Practice F 619, or as required by the standard for the medical
and record the body weights of all animals at 24, 48, and 72 h
device.
postinjection.
7.2 Method A, Intravenous:
8.2 Method B, Intraperitoneal:
7.2.1 The extract liquid is usually prepared from a saline
extraction vehicle. The dose of the extract liquid is 50 mL/kg 8.2.1 Method B is to be used with vegetable oil and similar
of body weight for each mouse, injected at a steady rate of not extraction vehicles designated for intraperitoneal injection.
more than 0.1 mL/s. If a hypotonic or hypertonic extract liquid
8.2.2 Agitate each extract liquid vigorously prior to with-
is used, then the injection rate is adjusted appropriately.
drawal of each inject
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