Assays

The Acute Toxicity “Six-Pack” is a series of studies designed to evaluate acute systemic toxicity and potential health hazards associated with a test substance. MB Research can provide our clients the convenience of running the battery of tests in one lab while also using modernized In Vitro assays that can replace certain traditional ones.

Oral Toxicity

Acute Oral Toxicity - Up and Down Procedure (UPD)
OCSPP 870.1100

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 Organization for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals, Guideline 425.

Dermal Toxicity

Acute Dermal Toxicity / LD50
OCSPP 870.1200

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

Acute Inhalation Toxicity
OCSPP 870.1300

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 Organization for Economic Co-operation and Development (OECD) Guideline for the Testing of Chemicals No. 403.

Ocular Irritation/Corrosion

Acute Ocular Irritation and Corrosion
OCSPP 870.2400

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 (BCOP) Assay.

Replacement Assays For Ocular Irritation/Corrosion

EpiOcular™ Eye Irritation Test (EIT)
OECD 492, GHS

The purpose of this study is to provide classification of chemicals concerning their eye irritation potential using an alternative to the Draize Rabbit Eye Test, according to the OECD Test Guideline No. 492, “Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage”. The EpiOcular™ EIT is intended to differentiate those materials that are UN GHS No Category (i.e., do not meet the requirements for UN GHS classification) from those that would require labeling as either UN GHS Category 1 or 2.

Bovine Corneal Opacity & Permeability (BCOP) Assay

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.

Bovine Corneal Opacity & Permeability Assay and EpiOcular™ Eye Irritation Test Combination Study (BCOP-EIT)
OECD 437, OECD 492, GHS

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.

Dermal Irritation/Corrosion

Acute Dermal Irritation and Corrosion
OCSPP 870.2500

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. 

In Vitro Replacement for Dermal Irritation

EpiDerm™ Skin Irritation Test (SIT)
OECD 439, GHS
The purpose of this study is to provide classification of the dermal irritation potential of chemicals by using a three-dimensional human epidermis model, according to the OECD Guideline for the Testing of Chemicals No. 439, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method”. The EpiDerm™ SIT allows discrimination between irritants (Category 2) and non-irritants, in accordance with U.N. GHS classification.

In Vitro Replacement for Dermal Corrosion

EpiDerm™ Skin Corrosion Test (SCT)
OECD 431, GHS
The purpose of this study is to provide classification of the dermal corrosion potential of chemicals by using a three-dimensional human epidermis model, according to the OECD Guideline for the Testing of Chemicals No. 431, “In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method”. The EpiDerm™ SCT allows discrimination between non-corrosive and corrosive substances in accordance with U.N. GHS classification. Corrosivity classification can be further divided into either optional Sub-category 1A or a combination of Sub-categories 1B and 1C.
Corrositex®
OECD 435, GHS

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).

Dermal Sensitization

Delayed Contact Dermal Sensitization Test – Buehler Method
OCSPP 870.2600

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.

Guinea Pig Maximization Test (GPMT)
OCSPP 870.2600

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.

Local Lymph Node Assay (LLNA-BrdU ELISA)
OCSPP 870.2600

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.

Replacement Assays for Dermal Sensitization

KeratinoSens™
OECD 442D

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.

Human Cell Line Activation Test (h-CLAT)
OECD 442E, GHS
To determine the skin sensitization potential of a test article due to cell activation by the measurement of changes in the expression of dendritic cell surface markers (CD86, CD54) via flow cytometry. The THP-1 human monocytic cell line serves as the test system. The h-CLAT is recommended by EURL ECVAM as part of an Integrated Approach to Testing and Assessment (IATA) to support the discrimination between sensitizers (i.e., UN GHS Category 1) and non-sensitizers for the purpose of hazard classification and labeling, per OECD Guideline 442E “In Vitro Skin Sensitization: Human Cell Line Activation Test (h-CLAT).”
Direct Peptide Reactivity Assay (DPRA)
OECD TG 442C

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.

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