ASTM F720-81(2002)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
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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e1
Designation:F720–81 (Reapproved 2002)
Standard Practice for
Testing Guinea Pigs for Contact Allergens: Guinea Pig
Maximization Test
This standard is issued under the fixed designation F 720; 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 Therefore, this test, while not guaranteeing that a material is
nonallergenic, is the most severe animal test in common use
1.1 This practice is intended to determine the potential for a
today.
substance, or material extract, to elicit contact dermal allerge-
nicity.
5. Materials and Manufacturer
1.2 This standard does not purport to address all of the
5.1 Hartley Strain Guinea Pigs, male, 300 to 500 g.
safety concerns, if any, associated with its use. It is the
5.1.1 Ten animals are used for each test material.
responsibility of the user of this standard to establish appro-
5.2 Freund’s Complete Adjuvant.
priate safety and health practices and determine the applica-
5.3 Occlusive Surgical Tape, 3.75 cm in width.
bility of regulatory limitations prior to use.
5.4 Elastic Bandage.
2. Referenced Documents 5.5 SodiumLaurylSulfate (10 weight %) in USPpetroleum
jelly.
2.1 ASTM Standards:
5.6 Positive Control Substance.
F 619 Practice for Extraction of Medical Plastics
5.6.1 5 % formaldehyde for water-soluble test substances.
3. Summary of Practice
6. Preparation of Test Samples
3.1 After a two-stage induction employing Freund’s com-
6.1 Samples for Intradermal Injection:
plete adjuvant and sodium lauryl sulfate, the substance or
6.1.1 Water-Soluble Constituents or Water Extract Liquids:
extract is placed on patches and then placed on the skin of
6.1.1.1 Dissolve the water soluble constituent up to its
guinea pigs. After 24 h, the patches are removed and the skin
maximum solubility, not to exceed a concentration of 10
examined for allergic reaction, and the intensity of the reaction
weight %, or obtain a water extraction liquid as described in
scored at the time of removal and 24 and 48 h subsequent to
Practice F 619.
removal.
6.1.1.2 Combine equal volumes of the liquid described in
4. Significance and Use
6.1.1.1 and Freund’s complete adjuvant. Homogenize by
continuous and vigorous vortex mixing for a minimum of 5
4.1 Inselectinganewmaterialforhumancontactinmedical
min. Emulsification is complete when a drop placed on the
applications, it is important to ensure that the material will not
surface of a water-ice bath remains intact.
stimulate the immune system to produce an allergic reaction.
6.1.1.3 Also prepare the constituent or extract to the same
The reaction would be due to substances which could leach out
concentration in water without Freund’s complete adjuvant.
of a material. Therefore, this practice provides for using
6.1.2 Oil Soluble Constituents:
material extracts. The rationale for this practice is based on the
6.1.2.1 Dissolve oil-soluble constituents in Freund’s com-
fact that the guinea pig has been shown to be the best animal
plete adjuvant to concentration of 10 weight %.
model for human allergic contact dermatitis. The use of
6.1.2.2 Combine equal volumes of the 10 % Freund’s adju-
Freund’s complete adjuvant and sodium lauryl sulfate tends to
vant solution with an equal volume of water by slowly adding
enhance the potential of a material to cause an allergy.
the water to the adjuvant while homogenizing with a rotating
stirrer. Homogenize by continuous and vigorous mixing for a
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
minimum of 5 min. Emulsification is complete when a drop
Surgical Materials and Devices and is the direct responsibility of Subcommittee
placed on the surface of a water-ice bath remains intact.
F04.16 on Biocompatibility Test Methods.
6.1.2.3 Also prepare the constituent to an equal concentra-
Current edition approved April 24, 1981. Published July 1981. Originally
tion without Freund’s complete adjuvant.
published as F 720 – 81.
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F720–81 (2002)
6.1.3 Vegetable Oil Extract Liquids: 7.2.3.1 Test solids as a 25 % concentration (providing this
concentration is not irritating) in petroleum jelly by weight.
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 F 619 with an equal volume of
7.1.2.3.
Freund’s complete adjuvant.
7.2.3.2 Test liquids in undiluted form consistent with 6.1.5.
6.1.3.2 Also prepare extract to an equal concentration in
Apply ona2by 2-cm piece of filter paper as outlined in
water without Freund’s complete adjuvant.
7.1.2.3.
6.1.4 Prepare control substances consistent with 6.1.1-
7.2.4 Occlude filter paper, and sample with occlusive surgi-
6.1.3.2.
cal tape and elastic bandage as described in 7.1.2.4.
NOTE 1—If th
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