Field of testing

Humans and animals have very complex reproductive processes. When various chemicals act on reproductive organs, they can cause morphological or functional changes. Therefore, multiple reproductive toxicity tests must be performed in combination to detect reproductive toxicity of the test substance.
Currently, the most commonly performed tests include fecundability and early embryo development test, embryonic and fetal developmental toxicity test, prenatal and postnatal development and maternal function test, and multi-generation reproduction.

Fecundability and early embryo development test (Seg 1, ICH 1 / Fertility test)

For male animals, test substance is administered from 63 days before or 28 days before mating to the end of mating. Female animals are given test substance from 14 days before mating until the conception (6 days after becoming pregnant). Then we check if there is any impaired fertility. In general, male and female rats are used for this test.

Embryonic and fetal developmental toxicity test (Seg 2, ICH 3 / Embryo-fetal development test)

The test substance is administered during the organogenic period(6-15 days of pregnancy) of the pregnant animal to investigate whether the fetus develops deformity, lethality, developmental delay, etc. The pregnant rats and rabbits are mainly used.

- Morphological examination of fetus: External appearance, abnormalities in internal organs and skeleton

Prenatal·postnatal outbreak and maternal function test (Seg 3, ICH 2 / Pre-and post-natal study with rat)

The test substance is administered from 6th day of pregnancy to 21st of day of mothering. Since this test in conducted to examine the growth and functioning of the next generation animals, pregnant rats are mainly used.

- Behavioral function test: Righting reflex, inferiority, traction, hearing, pupillary reflex, flywheel, passive avoidance reaction, water filled multiple T-maze, etc.

Multi-generation reproduction test (Multigeneration test)

This test is about pesticides and industrial chemicals. It is carried out on parental generation animals(F0), in which the male is exposed to the test substance through the mating period, the female is exposed before the mating, during the mating period , the pregnant period and the weaning period. This is to investigate the effects on the development and growth of next generation animals(F1). The same test is conducted for next generation animals. Laboratory animals are usually female or male rats.

Screening test for reproductive/developed toxicity (Reproductive developmental Toxicity screening test, OECD TG 421)

For male animals, the test substance is administered for 2 weeks before mating, during the mating period and for 2 weeks after mating. For female animals, the test substance is administered for 2 weeks before mating, during the mating period, pregnant period and until the 3rd day of mothering. This test is conducted to investigate the effects on general toxicity and reproduction/developed toxicity, mainly using rats.

Hormone analysis test

This test measures the hormone changes in the blood due to in-vivo exposure to medicines, natural substances, agrochemicals and other industrial chemicals using dedicated equipment for hormone analysis. It analyzes the hormone in the blood of laboratory animals throughout the general toxicity and special toxicity tests.

- Blood hormone analysis on rodents

- Blood hormone analysis on non-rodents

- Blood hormone analysis through repeated dose toxicity test

- Blood hormone analysis through reproductive and developmental toxicity test

Field of testing

Because of the wide variety of mechanisms that cause toxicity, several genotoxicity tests should be performed with batteries instead of just one genotoxicity test to determine the correct genotoxicity of a test substance. Currently, the most widely practiced 3-battery test methods are reverse mutation test, chromosomal abnormality test, and micronucleus test. Each test is carried out in accordance with the regulatory guidelines of the registration authority of test substance and GLP regulations.

Reverse mutation test (Bacterial reverse mutation test, Ames test)

Reverse mutation test is to measure genotoxicity by confirming that a specific amino acid synthesis is converted into an amino acid synthesis strain by using the microorganism whose synthesis of specific amino acid has been degraded.

In vitro chromosomal aberration test (In vitro chromosomal aberration assay)

As a test for measuring the structural abnormality of a chromosome using test substances, mammalian cells such as Chinese Hamster Lung (CHL) and Chinese Hamster Ovary (CHO) cells are generally used.

In vivo micronucleus test (In vivo micronucleus assay)

In the case of an in-vivo test, it is impossible to reproduce all conditions that may occur in a living body. In order to determine genotoxicity, in vivo tests using animals must be performed. The most widespread in vivo test is the micronucleus test, which suggests that if the number of multicellular red blood cells increases, the test substances have damaged the chromosome or cause an abnormality in the mitotic apparatus.

Tested areas

Reverse mutation test

In vitro chromosomal aberration test

In vivo micronucleus test

Tested areas

- 1st skin irritation test using rabbit

- Eye's mucous membrane irritation using rabbit

- VAginal mucous membrane irritation using rabbit

- Oral mucous membrane irritation test using hamster

Field of testing

Antigenicity test

The antigenicity test is to examine the shocks or allergic reaction caused by external substances such as medicines when those substances act as antigens in the body and are repeatedly exposed.

Cellular immunity test

This test examines the immune function of T-lymphocytes, which are responsible for attacking and defending against external substances that enter the body.

Humoral immunity test

This is a test to check the immune function of B-lymphocytes, which are responsible for the formation of antibodies against external substances that enter the body.

Macrophage function test

This test is to check the immune function of the macrophage, which provides a signal to the T-lymphocyte or B-lymphocyte in the body in order for them to function against external substances.

Natural killer cell function test

This is a test to check the immune function of natural killer cells that attack virus-infected cells or tumor cells in the body.

Tested areas

Antigenicity test

- Anaphylaxis shock reaction test

- Passive skin anaphylactic reaction test

- Skin sensitization test

- Phototoxicity and photosensitization test

Immunotoxicity Test

- Cellular immunity test

- Humoral immunity test

- Macrophage function test

- Natural killer cell function test

Tested areas

Toxicokinetics Test : Studies the toxicokinetics in a toxicity test

- Toxicokinetics test in a general toxicity test(single dose and repeated dose)

- Toxicokinetics test in a carcinogenicity test

- Toxicokinetics test in a reproduction-toxicity test

Pharmacokinetics test : Studies pharmacokinetics

- Pharmacokinetics test using beagle dogs

Preparation analysis : Drug analysis in the preparation

- Development of preparation analysis method

- Validation of preparation analysis method

- Test on content, safety and homogeneity of the preparation