Nonclinical and Clinical ServicesWe have renewed our web page for Nonclinical Services. Please find the link here

Nonclinical Studies

The Toxicological Science Division serves to perform nonclinical studies by taking full advantages of a vast array of techniques and renowned reliability that the former Mitsubishi Chemical Safety Institute Ltd. (MSI) had acquired through its broad range of accumulated experience.

Tests on Chemical Substances

Tests and Studies to Meet the Requirements of the Chemical Substances Control Law

We are experienced in safety evaluation of chemical substances from before the Chemical Substances Control Law (CSCL) came into force in 1974, and are consistently advancing with technology reflecting international regulatory trends. With the extensive experience and expertise we have accumulated over the years, we conduct all types of tests compliant with the CSCL. We conduct various GLP studies and tests which satisfy the requirements of the CSCL GLP as well as OECD GLP.
The Yokohama, Kashima, and Kumamoto Laboratories conduct biodegradation tests, bioaccumulation tests, reverse mutation tests (Ames tests), chromosomal aberration studies, 28- and 90-day repeated dose toxicity studies, partition coefficient (Pow) measurement, and polymer flow scheme tests. We also specialize in notification service for new chemical substances on behalf of clients.
With our advanced technology and knowledge accumulated through long-term experience, we offer superior solutions to our clients in conducting tests/studies on new chemical substances and analytically complex substances (mixture, reaction products, etc.) and in interpretation of test/study results. We can also introduce the relevant government agencies or consult with them on behalf of clients.
The Yokohama Laboratory conducts ecotoxicity studies which were added on April 1, 2004 in the CSCL requirements.
We offer various services besides the test/study items listed below. Please do not hesitate to contact us to discuss your specific needs.

Biodegradation Tests

We conduct biodegradation tests by the coulometer method. Besides, highly-volatile compounds can be detected by the closed bottle method.
Isolation, quantitative determination, and structure elucidation of degradation products are available when the substances are structurally modified by activated sludge.
We also conduct small-scale tests for biodegradation screening as well as biodegradation tests by the JIS method.

Bioaccumulation Tests

We conduct bioaccumulation measurement of chemical substances in carp by the flow-through method.
Besides, we have long-term experience in evaluation of volatile substances with a closed type flowing water system.

Partition Coefficient (Pow) Measurement

The Yokohama Laboratory conducts the measurement by the shake-flask method and HPLC method. Partition coefficients (Pow) between 1-octanol and water are used to evaluate accumulation levels in the CSCL.
Bioaccumulation tests in fish are not required when the log Pow is less than 3.5. However, this does not apply to surfactants, mixtures with molecular weight distribution, organometallic compounds, substances of low purity (excluding HPLC method), or inorganic compounds. In addition, measurement of dissociative substances will be performed under non-dissociative state in all cases.

Reverse Mutation Tests (Ames Tests)

This is the most commonly used mutagenicity screening method in the world. We generally use a total of 5 strains (4 strains of Salmonella typhimurium, 1 strain of Escherichia coli) to qualitatively determine mutagenicity.
We also perform studies required for notification of new chemical substances in the EU.

Chromosomal Aberration Studies Mouse lymphoma TK assay(MLA)

We also perform studies required for notification of new chemical substances in EU.

Repeated Dose Toxicity Studies in Mammals

We evaluate the effects of chemical substances in vivo after repeated administration.
This studycanbe performed in combination with reproduction test.
This study is performed in combination with the Ames or chromosomal aberration test to evaluate whether the chemical substances fall into the category of designated chemical substances.
Tests in combination with neurotoxicity evaluation, which are required for application of new chemical substances in the EU, are also available.

Polymer Flow Scheme Tests

Since the establishment of the polymer flow scheme in 1987, we have been conducting studies on over 600 new polymer compounds. With our long-term experience, know-how, and integrated approach we support our clients in notification of functional polymer compounds, including polymers degraded by acid/alkali and water-soluble polymers, which may be difficult for notification using the normal flow scheme.
We also support our clients in notification of Polymers of Low Concern

Ecotoxicity Studies

We evaluate the clastogenicity of chemical substances and levels(if present) in CHL/IU cells or humun lymphocytes by chromosomal aberration studies.
We evaluate the inducibility of gene mutation in chemical substauces by MLA as the incdicators of mouse lymphoma thymicdine kinase gene mutation.

All of our research and studies are in strict adherence to the laws concerning protection and management of animals with full respect of the standards concerning care and management of test animals, and have been accepted and certified for animal welfare practices.



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