| Objectives | |
| To evaluate the test article for irritancy potential utilizing the MATREXTM in vitro toxicity testing system. | |
| Introduction | |
| TESTSKINTM and MATREXTM are sophisticated in vitro systems. Developed in Organogenesis. Inc. of Cambridge, Massachusetts, they closely mimic human skin in structure and function. The Living Dermal Matrex (LDM)TM of a three-dimensional construct comprised of living cells in a collagen matrix. Nutrition is provided through the base via a permeable membrane, leaving the surface open to the atmosphere. This makes an ideal system for applying a variety of materials, including liquids, powders, oils, gels and creams
The Living Skin Equivalent (LSE)TM has all the features previously described, plus the formation of an actual epidermis, complete with stratum corneum.
TESTSKIN and MATREX, when used with the recommended cell metabolism assay, can quickly provide toxicological profiles. The procedure involves a solubilized, reactive tetrazolium salt (MTT), which is metabolized by, the mitochondria of living cells and converted to a purple formazan dye. The color intensity of the skin replica extract, measured photometrically, correlates directly with its viability. When measured against controls, values ranging from 0% to 1 00% (plus or minus approximately 20%) can be calculated for each dose of an applied substance. | |
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| Reference Articles | |
| CAMPOTMPROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results CAMPOTM KIWI FRUIT ENZYMES EXTRACT thl |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.9% | 0.1% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.9% | 0.1% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results FRUIT-METALLOENZYMES DETTM AQ-53 |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.7% | 0.3% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results FRUIT-ENZYMES DETTM BGC |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.3% | 0.7% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results FRUIT-ENZYMES DETÔ 108A |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.1% | 0.9% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results FRUIT ENZYMES DETTMBABY X-132 |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.8% | 0.9% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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top |
| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results FRUIT ENZYMES DETTMWGS |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.5% | 0.5% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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top |
| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results FRUIT ENZYMES DETTMCMB-100 |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.6% | 0.4% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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top |
| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| Results FRUIT ENZYMES DETTMCE-115-011 |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.2% | 0.8% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
 |
top |
| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| ResultsFRUIT ENZYMES DETTMJBS |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.9% | 0.1% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
 |
top |
| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples | |
| ResultsFRUIT ENZYMES DETTMMBC |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.7% | 0.3% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
 |
top |
| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| ResultsCAMPO PINEAPPLE ENZYMES EXTRACT NLC |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.9% | 0.1% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
 |
top |
| Reference Articles | |
| PROPYLENE GLYCOL & MORPHOLINE | |
| Method | |
| The appropriate dilutions of test sample and control articles were applied to MATREX. After the appropriate exposure period, the articles were rinsed from the MATREX surfaces. MTT (tetrazolium salt) assay medium ,vas utilized in order to quantifv cell metabolism. At the end of the staining period, excised portions of each MATREX were immersed in acidified isopropanol iviiich extracted the converted MI7 from the tissue samples. A Dynatech NM 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 57Onm. With the absorbance of a negative control defined as 100%, the percent absorbencies of the test and control articles were determined. The percentages listed below directly correlate with the cell metabolism in the MATREX samples. | |
| ResultsCAMPO PINEAPPLE ENZYMES EXTRACT cdp |
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 99.9% | 0.1% |
| (10% - 1 hr.) | LDM | 100% | -% |
| (1% - 1 hr.) | LDM | 100% | -% |
| Propylene glycol | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 73% | 27% |
| (10% - 1 hr.) | LDM | 99% | 1% |
| (1% - 1 hr.) | LDM | 96% | 4% |
| Morpholine | |||
| (% & Exposure) | System | Percent Viability | Percent Inhibition |
| (100% - 1 hr.) | LDM | 6% | 94% |
| (10% - 1 hr.) | LDM | 4% | 96% |
| (1% - 1 hr.) | LDM | 100% | 0% |
| HISTORICAL IN VITRO RESULTS: |
| Propylene glycol has historically been categorized as virtually non-irritating when tested using the Draize irritation methodologies. Morpholine has been categorized as moderately irritating .when tested in the same manner. |
| Discussions |
| The sponsor-submitted sample elicited in vitro results comparable to those recorded for propylene glycol |
| Conclusion |
| The results indicate that the sponsor-submitted product has virtually no irritation potential, under the conditions of this test. |
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