ASTM F720-13
(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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F720 − 13
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 4. Significance and Use
4.1 Inselectinganewmaterialforhumancontactinmedical
1.1 This practice is intended to determine the potential for a
applications, it is important to ensure that the material will not
substance, or material extract, to elicit contact dermal allerge-
stimulate the immune system to produce an allergic reaction.
nicity.
The reaction would be due to substances which could leach out
1.2 The values stated in SI units are to be regarded as
of a material. Therefore, this practice provides for using
standard. No other units of measurement are included in this
material extracts. The rationale for this practice is based on the
standard.
fact that the guinea pig has been shown to be the best animal
model for human allergic contact dermatitis. The use of
1.3 This standard does not purport to address all of the
Freund’s complete adjuvant and sodium lauryl sulfate tends to
safety concerns, if any, associated with its use. It is the
enhance the potential of a material to cause an allergy.
responsibility of the user of this standard to establish appro-
Therefore, this test, while not guaranteeing that a material is
priate safety and health practices and determine the applica-
nonallergenic, is the most severe animal test in common use
bility of regulatory limitations prior to use.
today.
2. Referenced Documents
5. Materials and Manufacturer
2
2.1 ASTM Standards:
5.1 Hartley Strain Guinea Pigs, male, 300 to 500 g.
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
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
6. Preparation of Test Samples
examined for allergic reaction, and the intensity of the reaction
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
maximum solubility, not to exceed a concentration of 10
weight %, or obtain a water extraction liquid as described in
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Practice F619.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
6.1.1.2 Combine equal volumes of the liquid described in
CurrenteditionapprovedJune1,2013.PublishedJuly2013.Originallyapproved
6.1.1.1 and Freund’s complete adjuvant. Homogenize by con-
in 1981. Last previous edition approved in 2012 as F720 – 81 (2012). DOI:
tinuous and vigorous vortex mixing for a minimum of 5 min.
10.1520/F0720-13.
2
Emulsification is complete when a drop placed on the surface
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
of a water-ice bath remains intact.
Standards volume information, refer to the standard’s Document Summary page on
6.1.1.3 Also prepare the constituent or extract to the same
the ASTM website.
3
concentration in water without Freund’s complete adjuvant.
Available from International Organization for Standardization (ISO), 1, ch. de
la Voie-Creuse, CP 56, CH-1211 Geneva 20, Switzerland, http://www.iso.org. 6.1.2 Oil Soluble Constituents:
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F720 − 13
6.1.2.1 Dissolve oil-soluble constituents in Freund’s com- 7.1.2.4 Apply filter paper to the injection site of the guinea
plete adjuvant to a concentration of 10 weight %. pigs. Cover with 3.75-cm occlusive surgical tape and wrap an
6.1.2.2 Combine equal volumes of the 10 % Freund’s adju- elastic bandage around the torso to secure the tape.
vant solution with an equal volu
...
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 − 81 (Reapproved 2012) F720 − 13
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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics
2
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.
5.4 Elastic Bandage.
5.5 Sodium Lauryl Sulfate (10 weight %) in USP petroleum jelly.
5.6 Positive Control Substance.
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 Oct. 1, 2012June 1, 2013. Published October 2012July 2013. Originally approved in 1981. Last previous edition approved in 20072012 as
ε1
F720 – 81 (2007)(2012). . DOI: 10.1520/F0720-81R12.10.1520/F0720-13.
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
3
volume information, refer to the standard’s Document Summary page on the ASTM website.
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 − 13
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 in 6.1.1.1 and Freund’s complete adjuvant. Homogenize by continuous
and vigorous vortex mixing for a minimum of 5 min. Emulsification is complete when a drop placed on the surface of a water-ice
bath remains intact.
6.1.1.3 Also prepare the constituent or extract to the same concentration in water without Freund’s complete adjuvan
...
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