Medical Materials & Technologies

BIOCOMPATIBILITY SUMMARY

Product Name: 3M™ Medical Silicone Tape 2477P

Effective: December 2020

ISO Guinea Pig Maximization Sensitization Test (Silicone and Acrylic Adhesive Tested)

The test article was evaluated for the potential to cause delayed dermal contact sensitization in a guinea

pig maximization test. This study was conducted based on the requirements of ISO 10993-10, Biological

evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. The test article was

extracted in 0.9% sodium chloride USP and sesame oil, NF. Each extract was intradermally injected and

occlusively patched to ten test guinea pigs (per extract). The extraction vehicle was similarly injected

and occlusively patched to five control guinea pigs (per vehicle). Following a recovery period, the test

and control animals received a challenge patch of the appropriate test article extract and the vehicle

control. All sites were scored for dermal reactions at 24 and 48 hours after patch removal. Results: The

test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea

pig. The test article was not considered a dermal sensitizer in the guinea pig maximization test.

CLIN-RPT-FINAL-INV-US-05-411272

The adhesive used in 2477P, as part of a different construction, has also been subjected to the following

pre-clinical biocompatibility testing by an outside laboratory under GLP:

Cytotoxicity Study Using the ISO Agarose Overlay Method (Silicone Adhesive Tested)

The test article was evaluated to determine the potential for cytotoxicity based on the requirements of

ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. Triplicate

wells were dosed with a 1 cm x 1 cm portion of the test article. Triplicate wells were dosed with a 1 cm

length of high density polyethylene as a negative control. Triplicate wells were dosed with a 1 cm x 1 cm

portion of latex as a positive control. Each was placed on an agarose surface directly overlaying a

subconfluent monolayer of L-929 mouse fibroblast cells. After incubating at 37°C in the presence of 5%

morphology and cell lysis. Results: The test article showed no evidence of causing any cell lysis or

toxicity. The test article met the requirements of the test since the grade was less than or equal to a

grade 2 (mild reactivity).

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ISO Skin Irritation Study in Rabbits (Silicone Adhesive Tested)

The test article was evaluated for primary skin irritation in accordance with the guidelines of ISO 10993-

10, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization. Two 25

mm x 25 mm sections of the test article and control article were topically applied to the skin of each of

three rabbits and left in place for a minimum of 23 and a maximum of 24 hours. The sites were graded

for erythema and edema at 1, 24, 48 and 72 hours after removal of the single sample application.

Results: There was no erythema and no edema observed on the skin of the animals treated with the test

article. The Primary Irritation Index (PII) for the test article was calculated to be 0.0/8.0. The response of

the test article was categorized as negligible.

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It is the responsibility of our customers to determine final suitability of our

products for their application. Final testing of a converted device made with this

material is the responsibility of the customer.