ASTM F719-20e1

Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

SIGNIFICANCE AND USE
4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.
SCOPE
1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.  
1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This standard may involve hazardous materials, operations, and equipment. 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.  
1.5 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.

General Information

• Status: Published
• Publication Date: 31-Mar-2020
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Refers: ASTM F619-03(2008) - Standard Practice for Extraction of Medical Plastics
• Effective Date: 01-Aug-2008
• Refers: ASTM F619-03 - Standard Practice for Extraction of Medical Plastics
• Effective Date: 01-Nov-2003
• Refers: ASTM F619-02 - Standard Practice for Extraction of Medical Plastics
• Effective Date: 10-Apr-2002
• Refers: ASTM F619-79(1997)e1 - Standard Practice for Extraction of Medical Plastics
• Effective Date: 10-Dec-1997

Overview

ASTM F719-20e1: Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation is an internationally recognized ASTM standard that outlines procedures for assessing the skin irritancy of various materials intended for human or animal contact. This practice is particularly significant for industries whose products routinely come into contact with skin, such as medical devices, textiles, and cosmetics. The test uses healthy young adult albino rabbits to evaluate both intact and abraded skin reactions when in contact with materials or their extracts. Results of this procedure provide valuable data on the biocompatibility of materials and their potential to cause erythema or edema, the primary indicators of skin irritation.

Key Topics

• Scope of Testing: ASTM F719-20e1 covers the procedures for exposing both abraded and intact rabbit skin to a test material, securing the contact, and evaluating the response.
• Materials and Equipment: The standard specifies forms of test specimens (liquids, solids, films), required controls, and necessary laboratory supplies such as gauze, adhesive tape, and polyethylene sleeves.
• Test Animal Care: Only healthy New Zealand albino rabbits are utilized in accordance with the Guide for the Care and Use of Laboratory Animals.
• Scoring and Interpretation: Erythema and edema are scored at set intervals post-exposure using a standardized table. The final assessment results in a Primary Irritation Index (PII), classifying the material’s irritancy as negligible, slight, moderate, or severe.
• Operator Training: Due to the manual nature and potential variability of the test, it is critical that only trained personnel administer the procedure to ensure safety and reliability.
• Safety Considerations: Users must exercise appropriate health, safety, and environmental controls, referencing regulatory requirements as needed.

Applications

This skin irritation testing standard has practical value and broad applications, particularly in these contexts:

• Medical Device Evaluation: Ensures that materials used in medical implants, bandages, or surgical instruments are not irritating to skin upon contact.
• Cosmetics and Personal Care: Supports safety validation for skin-contact formulations, protecting consumers from potential adverse reactions.
• Textiles and Wearables: Confirms that clothing, wearables, or other skin-contact fabrics meet safety requirements, minimizing customer complaints or recalls.
• Research and Development: Assists R&D teams in screening new materials for biocompatibility prior to further investment in product development.
• Regulatory Compliance: Satisfies requirements from global regulatory bodies and supports submissions for product approvals and registrations.

By following ASTM F719-20e1, stakeholders can demonstrate a commitment to product safety and compliance with internationally accepted best practices.

Related Standards

• ASTM F619 - Practice for Extraction of Materials Used in Medical Devices: Outlines procedures for preparing liquid extracts from materials, referenced in the skin irritation testing protocol.
• Guide for the Care and Use of Laboratory Animals (National Research Council): Defines standards for ethical animal care during testing.
• OECD Test Guidelines - Provide alternative and supplementary guidance for skin irritation testing in line with international regulatory expectations.

Understanding and implementing ASTM F719-20e1 helps organizations address skin irritancy risks, meet market and regulatory expectations, and ensure consumer safety across a wide range of products.

Standards Content (Sample)

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.
´1
Designation: F719 − 20
Standard Practice for
Testing Materials in Rabbits for Primary Skin Irritation
ThisstandardisissuedunderthefixeddesignationF719;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.
ε NOTE—Editorial correction was made to 8.1 in November 2020.
1. Scope 3. Summary of Practice
3.1 Exposure of skin to the test material is accomplished by
1.1 This practice covers a procedure by which the irritancy
means of a patch test technique employing two intact and two
ofamaterialmaybeassessedthroughcontactwithabradedand
abradedsitesonthebackofeachofthreealbinorabbitspertest
intact skin of rabbits.
article. The skin is clipped free of hair one day prior to testing.
1.2 The results of this practice depend upon the effective-
The test substance is applied using 0.5 mLfor liquids, 0.5 g for
ness with which contact between the skin and the test material
solidsorsemisolids,anda2.5by2.5-cmsquarepatchforfilms.
is established and maintained. Because of the operator tech-
After application, each test site is covered with a 2.5 by 2.5-cm
nique included in performing this test, it is important that the
gauze flat, and the entire trunk is occluded with a polyethylene
test be performed by personnel with appropriate training.
sleeve. After 24 h, the sleeve, flat, and test material are
1.3 The values stated in SI units are to be regarded as
removed, and test sites are evaluated for erythema and edema.
standard. No other units of measurement are included in this
4. Significance and Use
standard.
4.1 Materials that are to be in contact with the skin should
1.4 This standard may involve hazardous materials,
not cause irritation to the skin. Since it is probably the
operations, and equipment. This standard does not purport to
substancesleachedfromamaterialthatcausetheirritation,this
address all of the safety concerns, if any, associated with its
practice provides for direct material-skin contact testing or for
use. It is the responsibility of the user of this standard to
skin exposure to the liquid extract of the test material. The
establish appropriate safety, health, and environmental prac-
rationale for this rabbit test is that it is a comparatively quick
tices and determine the applicability of regulatory limitations
and sensitive method which, through use over the years, has
prior to use.
become a generally accepted method. Additionally, the albino
1.5 This international standard was developed in accor-
rabbit allows for easy visualization of erythema and edema,
dance with internationally recognized principles on standard-
which are the cardinal signs of skin irritation.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
5. Materials and Manufacture
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. 5.1 Young New Zealand Albino Rabbits, Healthy young
adult albino rabbits of either sex, weighing not less than 2 kg,
2. Referenced Documents shall be used. Animal care shall be in accordance with the
2 “Guide for Care and Use of Laboratory Animals”;
2.1 ASTM Standards:
5.2 Gauze Flats, 2.5 by 2.5-cm;
F619 Practice for Extraction of Materials Used in Medical
Devices
5.3 Polyethylene Sleeves, extra clear;
5.4 Adhesive Tape, ⁄2-in. width.
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
6. Test Specimen
Surgical Materials and Devices and is the direct responsibility of Subcommittee
6.1 The test specimen may be one of three forms:
F04.16 on Biocompatibility Test Methods.
Current edition approved April 1, 2020. Published June 2020. Originally
6.1.1 Test 0.5 mL of liquids, saline, or vegetable oil extract
approved in 1981. Last previous edition approved in 2012 as F719 – 81 (2012).
liquids obtained in accordance with Practice F619.
DOI: 10.1520/F0719-20E01.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on National Research Council, “Guide for the Care and Use of Laboratory
the ASTM website. Animals,” Washington, DC, National Academy Press, 2011.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F719 − 20
TABLE 1 Scoring Criteria for Test Reactions
6.1.2 Test 0.5 g of solids or semisolids.
6.1.3 Test films 2.5 by 2.5 cm. Reaction Description Score
Erythema Erythema and Eschar
NOTE 1—A vehicle control for liquids is required because of the
(ER) No erythema 0
potential for false positives due to skin temperature changes when
Very slight erythema (barely perceptible) 1
handlingrabbits.Positivecontrolsmaybeusedtovalidatethetestmethod.
Well-defined erythema (pale red in color) 2
The use of 2.5 % sodium lauryl sulfate (SLS) as a positive control is Moderate erythema (red and area well 3
suggested. For the positive control to be valid, the Primary Irritation Index defined)
Severe erythema (beet redness to slight 4
should be ≥2.0 indicating moderate to severe irritation response (Table
eschar formation)
2).
Edema (ED) Edema Formation
6.2 The pH of the solutions should be measured and No edema
...