Test Article Characterization – A GLP Requirement

5 Key Points of Test Article Characterization (TAC)

Test Article Characterization
Good Laboratory Practices (GLP)

Identity

The name under which the article will be tested Include CAS number, lot or batch, if applicable

Composition

The list of ingredients making up the test article

Strength

The stated concentration of an active ingredient in a test article mixture

Purity

The fraction that is the active ingredient (relative to impurities), usually expressed as a percent

Stability

The duration for which the test article will remain undegraded under the storage conditions provided

Why is Test Article Characterization (TAC) necessary?

When a study is conducted according to the Good Laboratory Practices regulations (GLPs), providing characterization of the material to be tested (the test article) to the Testing Facility (MB Research) is required.

Do you have characterization of the test article (e.g., Certificate of Analysis, or similar)?

Yes – Please provide this to MB Research prior to study initiation (signing the protocol, beginning the experiment).

No –Select ‘no test article characterization’ on the Sponsor Request section of the MB Research protocol. No further action is necessary. Refer to the GLP Compliance section below.

If yes, was test article characterization/analysis performed according to Good Laboratory Practices (GLPs), Good Manufacturing Procedures (GMPs), or neither*?

 Please select GLP, GMP, or non-GLP/non-GMP on the Sponsor Request section of the protocol.

Does your TAC include all five of the following GLP-required parameters?

Yes – The study will be in complete GLP compliance. No further action is necessary.

No – Refer to the GLP Compliance section below.

Good Laboratory Practices (GLP) Compliance 


A GLP compliance exception statement appears in the study report when TAC –

(1) is not provided

(2) is not provided prior to study initiation (signing the protocol)

(3) does not include all five of the parameters, and/or

(4) is not performed according to GLPs

MB Research Labs is a contract GLP toxicology lab with over 45yrs of experience in chemical, consumer product and cosmetic safety assessment.

www.mbresearch.com

MB specializes in in vitro toxicology testing and development of alternatives to animal models for toxicological assessments.

 

 

Pharmaceutical Toxicology Testing – MB Research Labs

Pharmaceutical Toxicology Testing
Pharmaceutical Toxicology Testing

Your Trusted Toxicology Testing Partner

We have the Experience.

Since 1972, MB Research Labs is a GLP contract research organization (CRO) that has been performing toxicology (acute, subchronic / chronic) and pharmacology studies for leaders in the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies.
With a wide range of testing protocols available, MB Research Labs offers comprehensive capabilities to to address your unique needs and goals with speed and accuracy.
Our expertise in many areas of in vivo and in vitro testing, research, and safety evaluations is the foundation upon how MB Research serves the pharmaceutical toxicology testing needs of both government and industry.

Complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB.
Our technical and support procedures are in full compliance with OECD, FDA, and EPA.

Related Toxicology Testing

EPA-OCSPP Testing

  • MB offers GLP Toxicology Testing for pesticides and chemicals.
  • Extensive list of Protocols Available
  • Discount Pricing

Photo-Toxicology

  • In Vitro 3T3 Neutral Red Uptake Phototoxicity Test
  • Monolayer & 3D Tissue Models
  • OECD 432 protocol

In Vitro Toxicology

  • Your Source for In Vitro & Alternatives to Animal Testing.
  • Cost Saving Screening Testing
  • Cosmetics & Personal Care Testing

MB Research Labs is a leader in the use and development of
in vitro and alternative toxicology test methods. We specialize in protocols for Eye and Skin Irritation, Corrosivity, Skin Sensitization, Genotoxicity, and Phototoxicity.

For more info about MB Research.

Chemical Toxicology Testing for Geeks

We Love Chemistry, How About You?

Chemical Toxicology Testing
Chemical Toxicology Testing

Chemical Toxicology Testing Overview

  • Over 45 Yrs Experience. MB Research Labs has been a primary provider of chemical safety testing services to the chemical and consumer products industries.
  • MB Research has been accredited by AAALAC International, a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs since 1975.
  • Over 50,000 toxicigical studies performed – Extensive expertise in conducting in vivo toxicology
  • Standardized GLP Protocols available for skin and eye irritation, oral and dermal toxicity, dermal sensitization assays and phototoxicity.

Toxicology Testing Experience You Are Looking For.

With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive capabilities to address your unique needs and goals.

MB has decades of expertise in many areas of in vivo and in vitro
testing, research, and safety evaluations, MB Research serves the testing needs of both government and industry.  Our complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB.  Our technical and support procedures are in full compliance with OECD, FDA, and EPA.

Chemical toxicology studies are routinely performed on a wide variety of compounds. The selection of specific studies to be conducted is based on the intended use of the compound and the applicable regulatory requirements. Protocols for the most commonly implemented regulatory studies are available upon request.

Related Links

Alternative Toxicology Testing – Local Lymph Node Assay (BrdU ELISA)

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

The LLNA-BrdU ELISA is conducted at MB Research Labs and is based upon the OECD 442B Testing Guideline.  The LLNA is an alternative toxicology assay for dermal sensitization using CBA/J mice.  The LLNA is an alternative to guinea pig studies that require more animals and long test durations.

LLNA-BrdU ELISA
LLNA-BrdU ELISA

Assay Principle:

To determine the sensitizing potential of topically applied test material utilizing the LLNA, and measurement of lymphocyte proliferation by BrdU incorporation detected by ELISA.

Irritation Screen Test:

An initial Irritation Screen is performed using 3-5 highest achievable  concentrations. The screen consists of 2 animals per concentration that will be dosed in an identical manner to that of the main test. Ear measurements will be taken prior to dosing on Study Days 1 and 3, and prior to euthanasia on Study Day 6.  Measurements taken on Study Days 3 and 6 will be compared to pre- dosing measurements. If there is no effect, or an increase of <25% in ear thickness, the same concentrations will be assayed in definitive test.

However, if significant ear swelling (ES) is present (>25% over control), then an extended screen (Quantitative Irritation Test; QIT) is recommended. The QIT is similar to the Irritation Screen except 4-6 concentrations will be assayed to determine the highest non-irritating concentration.

Definitive Sensitization Test:

The main test will be conducted by topically applying test material to the dorsum of the ears at the 3-5 highest achievable concentrations (100 [liquid only], 50, 25, 10, 5, 2.5, 1, 0.5, etc.), which do not cause severe irritation or overt systemic effects.  Ear measurements will be taken on Study Days 1 (prior to first dosing), 3 (approximately 48 hours after initial dosing) and 6 (prior to euthanasia). Animals will be injected with BrdU on Study Day 5, approximately 24 hours prior to euthanasia. Auricular lymph nodes will be collected on Study Day 6, a single-cell suspension will be created and lymph node cells (LNC) will be assayed for BrdU incorporation via ELISA.

Assay Interpretation:

  • A Positive Response is when a Stimulation Index (SI) is greater than or equal to 1.6 (relative to that of control lymph nodes).
  • A “Borderline Positive Response” is defined as an SI from 1.6 to 1.9; additional information and testing may be needed.
  • A Negative Response is when the SI is <1.6.

For more information about this and other studies, please see:  www.mbresearch.com

56th Society of Toxicology Annual Meeting 2017 – Baltimore, MD – MB Research Labs

MB Research Goes to Baltimore 2017 SOT
56th Annual Meeting – Society of Toxicology

SOT 2017 MB Research Informational Page

MB Research Goes to Baltimore – Society of Toxicology 2017

 

Join Us at the 56th Annual Meeting of the Society of Toxicology and ToxExpo , Baltimore, Maryland, March 12-16, 2017

Stop by Booth#: 2469 and meet some of our Study Directors and Client Services.

Scientific Posters:

The h-CLAT for Assessment of Dermal Sensitization Potency of the OECD Proficiency Chemicals and of Commercially Available Mixtures

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2748, Poster Board P116

Further Evaluation of Chemicals and Mixtures for Skin Sensitization Potential and Potency Using a Reconstructed Human Epithelium (RhE) Tissue Model and the IVSA.

Wed 1:15pm to 4:30pm. Session: Autoimmunity/Hypersensitivity, Abstract 2957, Poster Board P508

Historical Performance of Weak Sensitizers in Different Animal Models.

Tues 9:30am-12:45am. Session: Non-Phamaceutical Safety Assessment, Abstract 1873, Poster Board P449

Resolving Corrosive/Severe Irritant Ocular Classifications using an Alternative Dual Ex Vivo Assay System.

Wed 1:15pm-4:30pm. Session: Alternatives to Mammalian Models I, Abstract 2761, Poster Board P129

 

Toxicology Testing Services – Your Expert Toxicologist

Your Expert Source for Acute Toxicology Testing


Toxicology Testing Services
Toxicology Testing Services

Over 45 Years of Toxicology Testing – Chemicals, Pharmaceuticals, Cosmetics, Household Products, Personal Care Products

MB Research Laboratories, a GLP contract research Toxicology laboratory, has been conducting acute, subchronic / chronic toxicological and pharmacological studies since 1972. MB Research provides industry-leading general toxicology services for the pharmaceutical, biotechnology, medical device and agrochemical industries and government agencies. Routine and non-traditional toxicology studies are performed, custom testing services to meet specific testing needs is available.

Study Directors and technicians strive to consistently deliver exemplary results to support both Good Laboratory Practices(GLP) and non-GLP Toxicology studies. With a wide range of in vivo and in vitro test protocols available, MB Research Labs offers comprehensive Toxicology Testing capabilities to address your unique needs and goals. With expertise in many areas of in vivo and in vitro testing, research, and safety evaluations, MB Research serves the testing needs of both government and industry.

Complete support services including consultation, protocol development, quality assurance, analytical chemistry and archive facilities are integral components of studies performed at MB. Our technical and support procedures are in full compliance with OECD, FDA, and EPA.

MB Research Labs

US TSCA Changes Impact Animal Use in Chemical Testing

Changes in TSCA Reduces Use of Animals

https://www.washingtonpost.com/news/animalia/wp/2016/06/08/a-big-victory-for-lab-rats-congress-moves-to-limit-chemical-testing-on-animals/

As Regulators begin to initiate laws and regulations that require the reduction of using live animals for safety studies, more and more companies are looking for valid substitutes that are economical and thorough.

In Vitro Toxicology Testing

Let MB Research help in that search, In Vitro Toxicology Testing Services.

Since the late 1980s, MB Research has been a pioneer in the used and development of in vitro & alternative test methods, reducing the use of live animals in toxicological research.

What are the 3 Rs?

The principle of the 3Rs was first mentioned by William Russell and Rex Burch in 1959. In their book “The Principles of Humane Experimental Technique”, they classified humane techniques under the headings Refinement, Reduction, and Replacement, commonly known now as the 3Rs.

MB Research Laboratories prides itself on pursuing in vitro and alternative toxicological methods that Reduce, Refine and Replace the use of animals in laboratory research and has worked with many leaders in this field to advance the development, validation and regulatory acceptance of in vitro and alternative tests with a goal on replacing laboratory animals in toxicological research.

In Vitro Sensitization Testing for Fragrances

http://www.skininc.com/skinscience/ingredients/The-Frustration-Behind-Fragrance-389249991.html

MB Research actively has been utilizing in vitro and alternative toxicology test methods for determining dermal sensitization for many years.

Regulatory accepted assays are available.

We have an extensive background in in vivo and in vitro test method development.

For More: http://www.mbresearch.com/in-vitro-sensitization.htm

More on in vitro toxicology testing.

We want to be your Trusted Toxicology Partner.

Corrosivity Testing: Kit or Out-Sourced Testing?

in vitro Corrosivity testing - in vitro toxicology
in vitro Corrosivity testing – in vitro toxicology

Hazardous shipping labels can be complex.  There are kits that can be purchased that can satisfy regulatory requirements, but getting a kit alone does not provide they well-being you get when the test is performed by an experienced laboratory with a excellent quality assurance follow up and an acutal report.

See Corrositex.com

Having a test performed by a quality testing lab adds value to your product and shows to your customers that you are dedicated to their safety.

Consider testing with MB Research Labs…..we are your Trusted Testing Partner.

More info on in vitro toxicology testing.

In Vitro Tests and Weight of Evidence

Weight of Evidence-In Vitro Toxicology
Weight of Evidence-In Vitro Toxicology

Weigh of Evidence (WoE) testing with in vitro test methods is now being accepted by European chemical agencies to satisfy REACH requirements.  This is especially helpful when specific regulatory guidelines require complex safety testing but no validated in vitro test or alternative assay exists.

WoE must be accompanied with substantial background data to aid in acceptance of our provided safety data.  GLPs are a must.

MB Research Labs offers many in vitro test methods that are directly in-line with some regulatory testing requirements as well as novel in vitro test that have not been accepted yet but can still provide a strong case for safety assessments.