Safety and Biocompatibility Testing
Earth Glass products were tested in a variety of safety and biocompatibility studies under Good Laboratory Practice (GLP) guidelines by certified independent laboratories using International Organization for Standardization (ISO) 10993 protocols. All tests, except for muscle implantation (50:50 in LLDPE) were performed on pure, 100% product. Material was gamma irradiated, the most “destructive” method of commercial sterilization.
DERMAL IRRITECTION® TEST
Tests for evidence of irritation to the skin.
“The results indicated that the samples of Earth Glass products were classified as a dermal non-irritant.”
NOTOX / Mast Diagnostic
115 Rue Jules Barni
80000 Amiens, France
March, 2000
BECAM ASSAY (BOVINE EYE / CHICKEN CHORIOALLANTOIC MEMBRANE ASSAY)
tests for potential for corneal and conjunctival membrane irritancy.
“The effect of Earth Glass products in the BECAM assay was investigated. The bovine eye (BE) assay is indicative for corneal damage, while the chorioallantoic membrane (CAM) assay is used as an indication for conjunctival involvement. In the BE test the test substance revealed slight corneal damage consisting of diffuse and weak fluorescein staining. No effects were observed on the CAM. It is concluded that only slight irritation may be expected after acute eye exposure to Earth Glass products.”
NOTOX B.V.
Hambakenwetering 3
5231 DD’s-Hertogenbosch
The Netherlands
April, 2000
AMES MUTAGENICITY TEST
Tests for the evidence of chromosomal change or damage.
“Based on the results of this study it is concluded that Earth Glass products are not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.”
NOTOX B.V.
Hambakenwetering 3
5231 DD’s-Hertogenbosch
The Netherlands
May, 2000
CYTOTOXICITY TEST
Tests for the propensity to damage or kill living tissue cells. “Under the conditions of this study, the 1X MEM test extract showed no evidence of Earth Glass products causing cell lysis or toxicity. “
NAMSA
2261 Tracy Road
Northwood, OH 43619-1397
May, 2002
ISO RABBIT PYROGEN STUDY
Tests for the potential of inducing fever. “Under the conditions of this study, the total rise of rabbit temperature during the 3 hour observation period was within acceptable USP limits. The extract was judged as nonpyrogenic.”
NAMSA
9 Morgan
Irvine, CA 92618-2078
June, 2002
ISO MOUSE ACUTE SYSTEMIC TOXICITY STUDY
Tests for the potential of causing systemic reaction when injected. “Under the conditions of this study, there was no mortality or evidence of systemic toxicity from the extracts. Each test article extract met the test requirements.”
NAMSA
9 Morgan
Irvine, CA 92618-2078
June, 2002
ISO RABBIT ACUTE INTRACUTANEOUS REACTIVITY STUDY
Tests for skin irritation when injected into the skin. “Under the conditions of this study, there was no evidence of irritation from the extracts injected intracutaneously into rabbits. The Primary Irritation Index Characterization for the extracts was negligible.”
NAMSA
9 Morgan
Irvine, CA 92618-2078
June, 2002
IN VITRO HEMOLYSIS STUDY ( MODIFIED ASTM – EXTRACTION METHOD)
Tests for lysis (rupture) of blood cells.
“Under the conditions of this study, the mean hemolytic index for the test article extract was 0.0%. The test article extract was non-hemolytic.”
NAMSA
9 Morgan
Irvine, CA 92618-2078
June, 2002
ISO MUSCLE IMPLANTATION STUDY IN RABBITS (ONE WEEK)
Tests for inflammation, cell injury, or death with prolonged internal exposure One week rabbit muscle implantation study with histopathology using test items fabricated from 50% Earth Glass product. Test plaque fabricated with 50% Earth Glass product and 50% linear low density polyethylene. “The reaction was not significant. The test article was classified as a non-irritant.”
NAMSA
2261 Tracy Road
Northwood, OH 43619-1397
August, 2002
Complete test results on file.