ASTM F720-81(2007)e1
(Practice)Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
SIGNIFICANCE AND USE
In selecting a new material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction. The reaction would be due to substances which could leach out of a material. Therefore, this practice provides for using material extracts. The rationale for this practice is based on the fact that the guinea pig has been shown to be the best animal model for human allergic contact dermatitis. The use of Freund’complete adjuvant and sodium lauryl sulfate tends to enhance the potential of a material to cause an allergy. Therefore, this test, while not guaranteeing that a material is nonallergenic, is the most severe animal test in common use today.
SCOPE
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation: F720 − 81(Reapproved 2007)
Standard Practice for
Testing Guinea Pigs for Contact Allergens: Guinea Pig
Maximization Test
ThisstandardisissuedunderthefixeddesignationF720;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
´ NOTE—Formatting and grammar were corrected editorially throughout in April 2007.
1. Scope model for human allergic contact dermatitis. The use of
Freund’s complete adjuvant and sodium lauryl sulfate tends to
1.1 This practice is intended to determine the potential for a
enhance the potential of a material to cause an allergy.
substance, or material extract, to elicit contact dermal allerge-
Therefore, this test, while not guaranteeing that a material is
nicity.
nonallergenic, is the most severe animal test in common use
1.2 This standard does not purport to address all of the
today.
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
5. Materials and Manufacturer
priate safety and health practices and determine the applica-
5.1 Hartley Strain Guinea Pigs, male, 300 to 500 g.
bility of regulatory limitations prior to use.
5.1.1 Ten animals are used for each test material.
2. Referenced Documents
5.2 Freund’s Complete Adjuvant.
2.1 ASTM Standards:
5.3 Occlusive Surgical Tape, 3.75 cm in width.
F619 Practice for Extraction of Medical Plastics
5.4 Elastic Bandage.
3. Summary of Practice
5.5 Sodium Lauryl Sulfate (10 weight %) in USP petroleum
jelly.
3.1 After a two-stage induction employing Freund’s com-
plete adjuvant and sodium lauryl sulfate, the substance or
5.6 Positive Control Substance.
extract is placed on patches and then placed on the skin of
5.6.1 5 % formaldehyde for water-soluble test substances.
guinea pigs. After 24 h, the patches are removed and the skin
examined for allergic reaction, and the intensity of the reaction
6. Preparation of Test Samples
scored at the time of removal and 24 and 48 h subsequent to
6.1 Samples for Intradermal Injection:
removal.
6.1.1 Water-Soluble Constituents or Water Extract Liquids:
6.1.1.1 Dissolve the water-soluble constituent up to its
4. Significance and Use
maximum solubility, not to exceed a concentration of 10
4.1 Inselectinganewmaterialforhumancontactinmedical
weight %, or obtain a water extraction liquid as described in
applications, it is important to ensure that the material will not
Practice F619.
stimulate the immune system to produce an allergic reaction.
6.1.1.2 Combine equal volumes of the liquid described in
The reaction would be due to substances which could leach out
6.1.1.1 and Freund’s complete adjuvant. Homogenize by
of a material. Therefore, this practice provides for using
continuous and vigorous vortex mixing for a minimum of 5
material extracts. The rationale for this practice is based on the
min. Emulsification is complete when a drop placed on the
fact that the guinea pig has been shown to be the best animal
surface of a water-ice bath remains intact.
6.1.1.3 Also prepare the constituent or extract to the same
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
concentration in water without Freund’s complete adjuvant.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
6.1.2 Oil Soluble Constituents:
F04.16 on Biocompatibility Test Methods.
6.1.2.1 Dissolve oil-soluble constituents in Freund’s com-
Current edition approved Feb. 1, 2007. Published February 2007. Originally
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plete adjuvant to concentration of 10 weight %.
approved in 1981. Last previous edition approved in 2002 as F720 – 81 (2002) .
DOI: 10.1520/F0720-81R07E01.
6.1.2.2 Combine equal volumes of the 10 % Freund’s adju-
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
vant solution with an equal volume of water by slowly adding
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
the water to the adjuvant while homogenizing with a rotating
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. stirrer. Homogenize by continuous and vigorous mixing for a
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F720 − 81 (2007)
minimum of 5 min. Emulsification is complete when a drop 7.2.3.1 Test solids as a 25 % concentration (providing this
placed on the surface of a water-ice bath remains intact. concentration is not irritating) in petroleum jelly by weight.
6.1.2.3 Also prepare the constituent to an equal concentra- Apply ona2by 2-cm piece of filter paper as outlined in
tion without Freund’s complete adjuvant. 7.1.2.3.
6.1.3 Vegetable Oil Extract Liquids: 7.2.3.2 Test liquids in undiluted form consistent with 6.1.5.
6.1.3.1 Mix equal volumes of oil extract liquid obtained in Apply ona2by 2-cm piece of filter paper as outlined in
accordance with Practice F619 with an equal volume of 7.1.2.3.
Freund’s complete adjuvant. 7.2.4 Cover the filter paper and sample with occlusive
6.1.3.2 Also prepare extract to an equal concentration in surgical tape and elastic bandage as described in 7.1.2.4.
water without Freund’s complete adjuvant. 7.2.5
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