ASTM F720-17
(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
4.1 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’s 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 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, health and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F720 − 17
Standard Practice for
Testing Guinea Pigs for Contact Allergens: Guinea Pig
1
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.
1. Scope guinea pigs. After 24 h, the patches are removed and the skin
examined for allergic reaction, and the intensity of the reaction
1.1 This practice is intended to determine the potential for a
scored at the time of removal and 24 and 48 h subsequent to
substance, or material extract, to elicit contact dermal allerge-
removal.
nicity.
1.2 The values stated in SI units are to be regarded as 4. Significance and Use
standard. No other units of measurement are included in this
4.1 Inselectinganewmaterialforhumancontactinmedical
standard.
applications, it is important to ensure that the material will not
1.3 This standard does not purport to address all of the
stimulate the immune system to produce an allergic reaction.
safety concerns, if any, associated with its use. It is the
The reaction would be due to substances which could leach out
responsibility of the user of this standard to establish appro-
of a material. Therefore, this practice provides for using
priate safety, health and environmental practices and deter-
material extracts. The rationale for this practice is based on the
mine the applicability of regulatory limitations prior to use.
fact that the guinea pig has been shown to be the best animal
1.4 This international standard was developed in accor-
model for human allergic contact dermatitis. The use of
dance with internationally recognized principles on standard-
Freund’s complete adjuvant and sodium lauryl sulfate tends to
ization established in the Decision on Principles for the
enhance the potential of a material to cause an allergy.
Development of International Standards, Guides and Recom-
Therefore, this test, while not guaranteeing that a material is
mendations issued by the World Trade Organization Technical
nonallergenic, is the most severe animal test in common use
Barriers to Trade (TBT) Committee.
today.
2. Referenced Documents 5. Materials and Manufacturer
2
5.1 Hartley Strain Guinea Pigs, male, 300 to 500 g.
2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics 5.1.1 Ten animals are used for each test material.
3
2.2 ISO Standards:
5.2 Freund’s Complete Adjuvant.
ISO 10993–10 Biological evaluation of medical devices—
5.3 Occlusive Surgical Tape, 3.75 cm in width.
Part 10: Tests for irritation and skin sensitization
5.4 Elastic Bandage.
3. Summary of Practice
5.5 Sodium Lauryl Sulfate (10 weight %) in USP petroleum
3.1 After a two-stage induction employing Freund’s com- jelly.
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.
6. Preparation of Test Samples
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
6.1 Samples for Intradermal Injection:
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
6.1.1 Water-Soluble Constituents or Water Extract Liquids:
Current edition approved Sept. 1, 2017. Published September 2017. Originally
6.1.1.1 Dissolve the water-soluble constituent up to its
approved in 1981. Last previous edition approved in 2013 as F720 – 13. DOI:
maximum solubility, not to exceed a concentration of 10
10.1520/F0720-17.
2
weight %, or obtain a water extraction liquid as described in
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
Practice F619.
Standards volume information, refer to the standard’s Document Summary page on
6.1.1.2 Combine equal volumes of the liquid described in
the ASTM website.
3
6.1.1.1 and Freund’s complete adjuvant. Homogenize by con-
Available from International Organization for Standardization (ISO), 1, ch. de
la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org. tinuous and vigorous vortex mixing for a minimum of 5 min.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F720 − 17
Emulsification is complete when a drop placed on the surface 7.1.2.2 Ifthetestsampleisnon-irritating,treateachte
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F720 − 13 F720 − 17
Standard Practice for
Testing Guinea Pigs for Contact Allergens: Guinea Pig
1
Maximization Test
This standard is issued under the fixed designation F720; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 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 safety, health and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2
2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics
3
2.2 ISO Standards:
ISO 10993–10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
3. Summary of Practice
3.1 After a two-stage induction employing Freund’s complete adjuvant and sodium lauryl sulfate, the substance or extract is
placed on patches and then placed on the skin of guinea pigs. After 24 h, the patches are removed and the skin examined for allergic
reaction, and the intensity of the reaction scored at the time of removal and 24 and 48 h subsequent to removal.
4. Significance and Use
4.1 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’s 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.
5. Materials and Manufacturer
5.1 Hartley Strain Guinea Pigs, male, 300 to 500 g.
5.1.1 Ten animals are used for each test material.
5.2 Freund’s Complete Adjuvant.
5.3 Occlusive Surgical Tape, 3.75 cm in width.
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved June 1, 2013Sept. 1, 2017. Published July 2013September 2017. Originally approved in 1981. Last previous edition approved in 20122013 as
F720 – 81 (2012).F720 – 13. DOI: 10.1520/F0720-13.10.1520/F0720-17.
2
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 the ASTM website.
3
Available from International Organization for Standardization (ISO), 1, ch. de la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F720 − 17
5.4 Elastic Bandage.
5.5 Sodium Lauryl Sulfate (10 weight %) in USP petroleum jelly.
5.6 Positive Control Substance.
5.6.1 5 % formaldehyde for water-soluble test substances.
6. Preparation of Test Samples
6.1 Samples for Intradermal Injection:
6.1.1 Water-Soluble Constituents or Water Extract Liquids:
6.1.1.1 Dissolve the water-soluble constituent up to its maximum solubility, not to exceed a concentration of 10 weight %, or
obtain a water extraction liquid as described in Practice F619.
6.1.1.2 Combine equal volumes of the liquid described
...
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