Animal toxicity studies

The OECD TG 404; Acute Skin Irritation Test provides information on the health hazards of the test item (agrochemical or chemical product) after dermal application. Test system: Rabbit. Initially, In vitro skin Irritation Test (OECD TG 439) is performed. If more data are needed after the In vitro tests are completed, then the In Vivo version (OECD 404) on rabbit is performed. In this study, after single dermal application of test item, dermal irritation, signs of erythema / edema, lesions, their severity and levels of reversibility are evaluated. If responses persist at the end of the observation period, the test substance is classified as an irritant.

The OECD TG 405; Acute Eye Irritation/Corrosion Test provides information on the health hazards likely to arise from exposure to test substance (liquids, solids and aerosols) from ocular application (by application to the eye).  Test system: Rabbit

This study is performed to determine the toxicity of an orally ingested test item from exposure over a prolonged time period. It is often carried out as a follow-on study to acute or repeated dose 28-day oral toxicity studies, to determine the sub-chronic oral toxicity of the test item. The test is performed on rats and involves dividing the animals into sub-groups and administering a different fixed dose of the test item to the groups daily, through gavage or via their food/water, over a period of 90 days. Throughout this period, clinical and functional assessments are performed to determine the toxicity and thus health hazard of the chemical. Endocrine related measurements, such as thyroid function, are important to consider.
Test system : Rat.

This study is performed to provide data for quantitative inhalation risk assessments, i.e. characterize chemical toxicity following repeated exposure for a period of 90 days through the inhalation route. Groups of male and female rodents are exposed to the test item at three or more concentration levels (doses) for six hours per day for 90 days. Negative control and/or vehicle control groups are also maintained. Animals are exposed for five / seven days per week. The result of the study provides information including hematology, clinical chemistry, ophthalmology, gross pathology, organ weights, and histopathology, to help better characterize the toxicity of a test item.
Test system : Rat.

The objectives of the prenatal development toxicity study are to detect adverse effects on the pregnant female and on development of the embryo and fetus, consequent to exposure of the female, during the gestation period (from implantation to the day prior to parturition). The study design determines whether enhanced toxicity occurs in pregnant females, as related to non-pregnant females and, effects on embryo-fetal survival, fetal weight and fetal development.
Test system: Rabbit / Rat.

The objectives of a two-generation reproductive toxicity study are to detect the adverse effects on integrity and performance of the male and female reproductive systems and, on the growth and development of the offspring, on exposure to the test item. This study provides an estimation of a no-observed-adverse-effect level (NOAEL) and an understanding of adverse effects on reproduction, parturition, lactation and postnatal development, including growth and sexual development.
Test system: Rat.

This study is performed to examine the effect of test item exposure on male and female reproductive performance. This study design includes determination of endocrine disruptor endpoints; in particular, the measure of anogenital distance and male nipple retention in pups and thyroid examination. Other endpoints for this study include evaluation of the adverse effects of test item on general reproductive performance, estrous cycles, mating performance, littering, offspring survival development and growth to mid-lactation, organ weights and histopathology of reproductive organs and the thyroid.
Test system: Rat.

This study is performed to examine the effects of test item exposure on male and female reproductive performance, in addition to the standard requirements for 28 days repeat dose toxicity study. The study is a combination of OECD TG 421 and OECD TG 407, adding additional endpoints including clinical pathology, full histopathology and neurobehavioral assessments.
Test system: Rat.

This study is a stepwise procedure with the use of a minimal number of animals per step, performed to obtain sufficient information on the acute toxicity of a test item, to enable its classification. The test item is administered orally to a group of rodents at one of the defined doses. Each step of the stepwise procedure consists of three rodents of a single sex (typically females). The absence or presence of compound-related mortality dosed at one step determines the next step. 
Test system: Rat.

This method, proposed by Bruce in 1985, use an up-and-down procedure (UDP) for the determination of acute toxicity of test item. The method permits estimation of an LD₅₀ with a confidence interval.The results allow for classification of test item for acute toxicity, according to the Globally Harmonised System of classification and labelling of chemicals. The guideline describes a limit test and a main test. Rodents are dosed one at a time and observed for a minimum of 48-hours before deciding on whether and how much to dose the next animal.
Test system: Mouse/Rat.

The objectives of the extended one generation study are to determine the adverse reproductive and developmental effects that may occur as a result of pre- and postnatal exposure to the test item, as well as an evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring.  This study evaluates reproductive performance, necropsy, organ weights, sperm motility/counts/morphology, histopathology and ovarian follicle counts of the offspring (F1 generation).
Test system: Rat.