Regulatory Testing
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OECD Assays
In Vitro Assays
The Corrositex® assay is performed using a kit produced and distributed by In Vitro International. The kit contains tubes of proprietary buffers, a Chemical Detection System (CDS), and components used to make synthetic proteinaceous macromolecular bio‐barriers. After preliminary testing to determine if the test article is compatible with the Corrositex® assay (qualification) and to determine cut‐off times (categorization), the test article is applied topically on prepared bio‐barriers set atop vials of CDS. The amount of time it takes for the test article to penetrate the bio‐barriers and cause a visually detectable change in the CDS (breakthrough time) can be used to determine the UN Packing Group or the UN GHS Subcategory (classification).
The Irritection® Assay System uses an in vitro method to determine ocular irritation and predict U.N. GHS classification for chemicals or mixtures. This study is designed to comply with the standards set forth in the OECD Guideline for the Testing of Chemicals No. 496. For more information, please click here.
The assay is designed to detect the phototoxicity induced by the combined action of a test article and light by using an in vitro cytotoxicity assay with the Balb/c 3T3 mouse fibroblast cell line. The test identifies aqueous-soluble compounds (or formulations) that have the potential to exhibit in vivo phototoxicity.
Upon exposure to skin sensitizers, the KeratinoSens™ Test measures activation of Keap1-Nrf2-antioxidant/electrophile response element (ARE). These tests use an immortalized, adherent, human keratinocyte cell line (HaCaT) that was transfected with a plasmid to monitor luciferase gene induction.
The DPRA is an in chemico method that quantifies cysteine‐ or lysine‐containing peptide depletion following 24 hours incubation with the test article (TA). Relative peptide concentration is measured by HPLC with gradient elution and UV detection at 220 nm. Cysteine and lysine peptide percent depletion values are then calculated and used in a prediction model, which allows assigning the TA to one of four reactivity classes used to support the discrimination between sensitizers and sonosensitizers.
Alternative Assays
Freshly harvested bovine corneas from the eyes of cattle are utilized in the BCOP test method in order to evaluate the ocular irritancy and corrosive potential of a test chemical by assessing quantitative measurements of:
(1) Changes in corneal opacity, measured with an opacimeter
(2) Corneal permeability, measured by a visible light spectrophotometer
Both measurements are used to calculate an In Vitro Irritation Score (IVIS), which is used to assign a classification category.
The objective of this study is to determine the potential for ocular irritation using OECD Guidelines for the Testing of Chemicals, Nos. 492 and 437, which serve as alternatives to the traditional Draize methodology. The use of two internationally-validated, OECD-accepted non-animal tests can provide a GHS categorization for the vast majority of test articles. The combination of the Bovine Corneal Opacity and Permeability Test and EpiOcular™ Eye Irritation Test followed by a Weight-of-Evidence analysis of the results allows for the classification of GHS Category 2.
The Local Lymph Node Assay (LLNA) is alternative study to the Guinea Pig Sensitization Test used for determining the sensitizing potential of materials. Following exposure to a sensitizing test substance, lymphocyte proliferation occurs in the lymph node local to the site of exposure. The LLNA measures increased proliferation of lymphocytes in the auricular lymph node which drain the site of exposure; ears). Proliferation is assessed by determining the incorporation of the thymidine analog, bromodeoxyuridine (BrdU) into the DNA of lymph node cells using an enzyme-linked immunosorbent assay (ELISA).
Additional Assays
The purpose of this study is to determine the potential of toxicity of the test article when applied dermally. This study is designed to comply with the standards set forth of in the current Organisation for Economic Co-operation and Development (OECD) Guideline for the Testing of Chemicals, No. 402.
EPA-OCSPP Assays
Oral Toxicity
The purpose of this study is to determine the potential for toxicity of the test article when administered orally. This study is designed to comply with the standards set forth in the current U.S. Environmental Protection Agency (EPA) Health Effects Test Guidelines, OCSPP 870.1100, and in the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals, Guideline 425.
Dermal Toxicity
The purpose of this study is to determine the potential for toxicity of the test article when applied dermally for a 24-hour exposure. This study is designed to comply with the standards set forth in the current U.S. Environmental Protection Agency (EPA) Health Effects Test Guideline OCSPP 870.1200: Acute Dermal Toxicity and U.S. Department of Transportation (DOT) 49 CFR 173.132(b)(2).
Inhalation Toxicity
The purpose of this study is to provide information on health effects that may arise from short term exposure by the inhalation route. This study is designed to comply with the standards set forth in U.S. Environmental Protection Agency (EPA) Health Effects Test Guideline, OCSPP 870.1300 and The Organisation for Economic Co-operation and Development (OECD) Guideline for the Testing of Chemicals No. 403.
Ocular Irritation
This study assesses the potential of a test article to cause irritation or corrosion to the eye by evaluation for up to 21 days following a single exposure. The intent of this study is to evaluate test articles that have been identified as not severely irritating or corrosive to the eye according to the OECD-recommended method: the Bovine Corneal Opacity and Permeability Assay (BCOP).
Dermal Irritation
The study is designed to determine the skin irritancy or corrosive potential of a test article. This determination is made by treating the skin of up to three test subjects for a three-minute, one-hour and/or four-hour exposure period and evaluating the skin at scheduled time points for up to 14 days.
Dermal Sensitization
The purpose of this study is to determine the potential of a product to promote skin sensitization reactions after repeated applications using the method of Ritz and Buehler, 1980, Current Concepts in Cutaneous Toxicity. This study is designed to comply with the standards set forth in U.S. Environmental Protection Agency (EPA) Health Effects Test Guideline OCSPP 870.2600: Skin Sensitization, and The Organisation for Economic Co-operation and Development (OECD) Guideline for the Testing of Chemicals No. 406: Skin Sensitization.
Contact dermal sensitization is an immunological process where the host animal, through repeated skin exposure, acquires a specific allergic sensitivity to a substance. In the Guinea Pig Maximization (GPMT) model, contact dermal sensitivity is manifested as increased erythema.
The purpose of this study is to determine the sensitizing potential of topically applied test articles. This LLNA protocol, utilizing the BrdU ELISA method, is designed to be a stand-alone assay for dermal sensitization as described in the NIH report “The Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals/Compounds,” NIH No. 99-4494, and the LLNA test guidelines as defined in EPA OCSPP 870.2600 and OECD Guideline for the Testing of Chemicals No. 442B.
ISO-USP Assays
In Vitro Assays
Upon exposure to skin sensitizers, the KeratinoSens™ Test measures activation of Keap1-Nrf2-antioxidant/electrophile response element (ARE). These tests use an immortalized, adherent, human keratinocyte cell line (HaCaT) that was transfected with a plasmid to monitor luciferase gene induction.
Alternative Assays
The Local Lymph Node Assay (LLNA) is alternative study to the Guinea Pig Sensitization Test used for determining the sensitizing potential of materials. Following exposure to a sensitizing test substance, lymphocyte proliferation occurs in the lymph node local to the site of exposure. The LLNA measures increased proliferation of lymphocytes in the auricular lymph node which drain the site of exposure; ears). Proliferation is assessed by determining the incorporation of the thymidine analog, bromodeoxyuridine (BrdU) into the DNA of lymph node cells using an enzyme-linked immunosorbent assay (ELISA).
Additional Assays
For more information about our 10993-23 Assays, please contact our Client Services Team at clientservices@mbresearch.com or call 215-536-4110.
For more information about our 10993-23 Assays, please contact our Client Services Team at clientservices@mbresearch.com or call 215-536-4110.
For more information about our 10993-23 Assays, please contact our Client Services Team at clientservices@mbresearch.com or call 215-536-4110.
For more information about our 10993-23 Assays, please contact our Client Services Team at clientservices@mbresearch.com or call 215-536-4110.
For more information about our 10993-23 Assays, please contact our Client Services Team at clientservices@mbresearch.com or call 215-536-4110.
For more information about our 10993-23 Assays, please contact our Client Services Team at clientservices@mbresearch.com or call 215-536-4110.
For more information about our 10993-23 Special Irritation Tests, please contact our Client Services Team at clientservices@mbresearch.com or call 215-536-4110.
DOT Assays
Data analysis will be performed in accordance with EPA Health Effects Test Guideline OCSPP 870.1000: Acute Toxicity Testing and DOT 49 CFR 173.132 (a)(1)(ii) and 49 CFR 173.133(a)(1).
Data analysis will be performed in accordance with the current EPA Health Effects Test Guidelines, OCSPP 870.1100, the Consumer Product Safety Commission (CPSC) issued pursuant to and for the implementation of the Federal Hazardous Substances Act, the current U.S. Department of Transportation (DOT), 16 CFR Part 1500.3(c)(2)(i)(A), 49 CFR 173.132(a), and/or in OECD Guidelines for the Testing of Chemicals, Guideline 423 and 425. Guideline 423 is referred to in OCSPP 870.1000 as an acceptable method to assess lethality within a dose range.
CPSC/FHSA Assays
The study is designed to determine the skin irritancy or corrosive potential of a test article. This determination is made by treating the skin of up to three test subjects for a three-minute, one-hour and/or four-hour exposure period and evaluating the skin at scheduled time points for up to 14 days.
Data analysis will be performed in accordance with the current EPA Health Effects Test Guidelines, OCSPP 870.1100, the Consumer Product Safety Commission (CPSC) issued pursuant to and for the implementation of the Federal Hazardous Substances Act, the current U.S. Department of Transportation (DOT), 16 CFR Part 1500.3(c)(2)(i)(A), 49 CFR 173.132(a), and/or in OECD Guidelines for the Testing of Chemicals, Guideline 423 and 425. Guideline 423 is referred to in OCSPP 870.1000 as an acceptable method to assess lethality within a dose range.
