Medical Device Testing Guide - Toxikon Corporation

Rev. May 2011
injected intracutaneously with the test article and control materials. The injected sites are examined over a seventy-two hour
period for evidence of tissue reaction such as erythema, edema, or necrosis. Observations are scored according to the
Classification System for Scoring Skin Reactions (Draize scale). At the end of the observation period the scores are used to
determine an overall mean reaction score for the test article versus the corresponding control article. The requirements of the
test are met if the difference of the mean reaction score for the test article and the control article is 1.0 or less.
Approximate turnaround time is four to five weeks.
AC02-1
AC02-2
AC02-3
AC03-1
AC03-2
AC03-3
AC04-1
AC04-2
AC04-3
Primary Skin Irritation
1 Exposure/1 Extract-Sample needed: 120 cm² 0.5 mm thick, 60 cm² 0.5 mm thick, or 4 g
1 Exposure/2 Extracts-Sample needed: 240 cm² 0.5 mm thick, 120 cm² 0.5 mm thick, or 8 g
Direct Exposure-Sample needed: 6 pieces at 2.5 cm x 2.5 cm, or 4 g
The Primary Skin Irritation test assesses the potential of a test article to produce dermal irritation after a single topical exposure
in rabbits. The test article may be exposed directly or through test article extracts. Extracts of the test material are prepared in
a polar (saline) and/or non-polar (cotton seed oil) solutions. After preparing the skin sites, the test article is kept in contact with
the skin by wrapping with an impervious bandage for a minimum exposure of four hours. After the exposure period, the test
article is removed and the skin sites are observed typically over a seventy-two hour observation period for signs of irritation.
Observations are scored according to the Classification System for Scoring Skin Reactions (Draize scale). The scores obtained
are used to calculate the Primary Irritation Index
Approximate turnaround time is five to six weeks.
Primary Ocular Irritation
1 Exposure/1 Extract-Sample needed: 120 cm² < 0.5 mm thick, 60 cm² 0.5 mm thick, or 4 g
1 Exposure/2 Extracts-Sample needed: 240 cm² < 0.5 mm thick, 120 cm² 0.5 mm thick, or 8 g
Direct Exposure-Sample needed: 5 mL
The Primary Ocular Irritation test is performed for materials that will come in contact with the eye or eyelid. The test article
will be exposed to the test system directly or through test article extracts. Extracts of the test material are prepared in a polar
(saline) and/or non-polar (cottonseed oil) solutions. Rabbits are treated by placing the test article material on the lower averted
lid of the left eye of each animal. The right eye remains untreated and serves as a control. The eyes are examined typically
over a period of seventy-two hours and scored according to the Classification System for scoring ocular lesions. The test
article is considered an eye irritant if more than one of the animals in the test group exhibits a positive reaction.
Approximate turnaround time is five to six weeks.
Primary Buccal (Mucosal) Irritation
1 Exposure/1 Extract-Sample needed: 120 cm² 0.5 mm thick, 60 cm² 0.5 mm thick, or 4 g
1 Exposure/2 Extracts-Sample needed: 240 cm² 0.5 mm thick, 120 cm² 0.5 mm thick, or 8 g
Direct Exposure-Sample needed: 4 g
This test evaluates the potential of materials or devices to produce irritation when in contact with the buccal tissue (cheek
pouch) of three Syrian Golden Hamsters. The test article will be exposed to the test system directly or through test article
extracts. Extracts of the test material are prepared in a polar (saline) and/or non-polar (cotton seed oil) solutions. The animals
are exposed to the test article for a minimum of five minutes every hour for four hours. Test and control sites are scored
macroscopically after the last dose and again at twenty-four hours. Following the twenty-four hour scoring, tissues are
collected for microscopic evaluation by a pathologist. The scores obtained from the microscopic evaluation are used to
determine the irritation level. The irritation level (group average) for the control is subtracted from the group average of the
test article to obtain the Irritation Index. The Irritation Index for the test article is categorized as a non-, minimal, mild,
moderate or severe irritant.
Approximate turnaround time is seven to eight weeks.
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