ASTM-D6355 2007(Redline)

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D6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves (Redline)

Published By	Publication Date	Number of Pages
ASTM	2007	8

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Description

1. Scope

1.1 This test method is designed to evaluate the potential of glove materials under test to induce and elicit Type IV skin sensitization reactions (that is, allergic contact dermatitis) in humans.

1.2 This test method should be used by individuals experienced in or under the supervision of those experienced in the use of good clinical practice procedures.

1.3 During the performance of the Human Repeat Insult Patch Test (RIPT) for determining sensitization, investigators are confronted with skin responses that represent skin irritation (non-immunologic responses) or allergic contact dermatitis (ACD). The numerical scoring system for grading the intensity of both are similar and test facilities may vary in their scores that describe intensities of allergic and irritant skin responses. The hallmark of a mild allergic contact dermatitis is a sustained palpable erythematous reaction. Delayed-type allergic contact reactions from patch tests have intensity characteristics that favor scores of higher values for longer periods of time and typically do not produce a minimal score (score of 1, a just-perceptible erythema) for short durations (less than 48 h). It is the responsibility of the investigator to evaluate the scores in light of irritant reactions so that the responses are allergic in nature and not irritant. The investigator should denote a final score as either due to contact allergy or irritation. Paragraphs 9.5-9.5.5 describe a commonly used scoring system and discuss allergic and irritant responses in detail.

1.4 The Draize RIPT was published in 1944 as an attempt to decrease the frequency ACD. The test techniques at that time were just being validated and this experimental design was largely empiric. The principle of the test is as follows:

1.4.1 Multiple inductions of the study material at relatively non or low irritancy levels,

1.4.2 Approximately a two-week rest period, and

1.4.3 A standard diagnostic challenge of approximately 48 h and a delayed reading at approximately 96 h after patch application.

1.5 In the intervening years, with further experimentation added to this empiric approach, three additional principles have been learned:

1.5.1 Increasing the concentration of the study material,

1.5.2 Defining a no effect level (this is possible with only individual ingredients and not the final study material), and

1.5.3 The enhanced sensitivity and the use of occlusion (where occlusion would not ordinarily be present).

1.6 In 1945, Henderson and Riley demonstrated that a test panel s

Additional information

Standard Title	D6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves (Redline)
Published Code	ASTM
Publication Date	2007
Pages Count	8

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ASTM-D6355 2007(Redline)

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