ASTM F720-81(2007)

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.
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.

General Information

• Status: Historical
• Publication Date: 31-Jan-2007
• ICS: 11.220 - Veterinary medicine
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Replaces: ASTM F720-81(2002)e1 - Standard Practice for Testing Guinea Pigs for Contact Allergens Guinea Pig Maximization Test
• Effective Date: 01-Feb-2007
• Replaced By: ASTM F720-81(2007)e1 - Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
• Effective Date: 01-Feb-2007
• Referred By: ASTM F3089-23 - Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2212-20 - Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
• Effective Date: 01-Feb-2007
• Referred By: ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2147-01(2016) - Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2148-18 - Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)
• Effective Date: 01-Feb-2007

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F720–81 (Reapproved 2007)
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.
1. Scope enhance the potential of a material to cause an allergy.
Therefore, this test, while not guaranteeing that a material is
1.1 This practice is intended to determine the potential for a
nonallergenic, is the most severe animal test in common use
substance, or material extract, to elicit contact dermal allerge-
today.
nicity.
1.2 This standard does not purport to address all of the
5. Materials and Manufacturer
safety concerns, if any, associated with its use. It is the
5.1 Hartley Strain Guinea Pigs, male, 300 to 500 g.
responsibility of the user of this standard to establish appro-
5.1.1 Ten animals are used for each test material.
priate safety and health practices and determine the applica-
5.2 Freund’s Complete Adjuvant.
bility of regulatory limitations prior to use.
5.3 Occlusive Surgical Tape, 3.75 cm in width.
2. Referenced Documents 5.4 Elastic Bandage.
5.5 SodiumLaurylSulfate (10 weight %) in USPpetroleum
2.1 ASTM Standards:
jelly.
F 619 Practice for Extraction of Medical Plastics
5.6 Positive Control Substance.
3. Summary of Practice 5.6.1 5 % formaldehyde for water-soluble test substances.
3.1 After a two-stage induction employing Freund’s com-
6. Preparation of Test Samples
plete adjuvant and sodium lauryl sulfate, the substance or
6.1 Samples for Intradermal Injection:
extract is placed on patches and then placed on the skin of
6.1.1 Water-Soluble Constituents or Water Extract Liquids:
guinea pigs. After 24 h, the patches are removed and the skin
6.1.1.1 Dissolve the water soluble constituent up to its
examined for allergic reaction, and the intensity of the reaction
maximum solubility, not to exceed a concentration of 10
scored at the time of removal and 24 and 48 h subsequent to
weight %, or obtain a water extraction liquid as described in
removal.
Practice F 619.
4. Significance and Use
6.1.1.2 Combine equal volumes of the liquid described in
6.1.1.1 and Freund’s complete adjuvant. Homogenize by
4.1 Inselectinganewmaterialforhumancontactinmedical
continuous and vigorous vortex mixing for a minimum of 5
applications, it is important to ensure that the material will not
min. Emulsification is complete when a drop placed on the
stimulate the immune system to produce an allergic reaction.
surface of a water-ice bath remains intact.
The reaction would be due to substances which could leach out
6.1.1.3 Also prepare the constituent or extract to the same
of a material. Therefore, this practice provides for using
concentration in water without Freund’s complete adjuvant.
material extracts. The rationale for this practice is based on the
6.1.2 Oil Soluble Constituents:
fact that the guinea pig has been shown to be the best animal
6.1.2.1 Dissolve oil-soluble constituents in Freund’s com-
model for human allergic contact dermatitis. The use of
plete adjuvant to concentration of 10 weight %.
Freund’s complete adjuvant and sodium lauryl sulfate tends to
6.1.2.2 Combine equal volumes of the 10 % Freund’s adju-
vant solution with an equal volume of water by slowly adding
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
the water to the adjuvant while homogenizing with a rotating
Surgical Materials and Devices and is the direct responsibility of Subcommittee
stirrer. Homogenize by continuous and vigorous mixing for a
F04.16 on Biocompatibility Test Methods.
minimum of 5 min. Emulsification is complete when a drop
Current edition approved Feb. 1, 2007. Published February 2007. Originally
e1
placed on the surface of a water-ice bath remains intact.
approved in 1981. Last previous edition approved in 2002 as F 720 – 81 (2002) .
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
6.1.2.3 Also prepare the constituent to an equal concentra-
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
tion without Freund’s complete adjuvant.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
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F720–81 (2007)
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
...