Toxicology:
Safety Assessment & Testing

Acute Toxicity Studies: To determine the risk assessment profile of test item for the purpose of classification, labeling and packaging to meet global regulatory requirements.

Sub-Acute/Sub-Chronic Toxicity Studies: To evaluate target organ toxicity, to ascertain the effects of prolonged dosing & establish safety margins of the test item.

Chronic Toxicity & Carcinogenicity Studies: To generate preclinical information used for assessing safety and risk. To observe test animals for a major portion of their life span for development of neoplastic lesions during or after exposure to various doses of test item.

*Supported by our European partner (Europe: OECD GLP accredited lab).

Alternative test methods to animal testing have become enormous relevance over the last few years. Many acute toxicity tests are being effectively replaced by validated in vitro alternatives. For example, in vivo studies in the cosmetics industry are completely prohibited since 2013. Thus, in vitro toxicology is becoming an emerging field in the area of regulatory toxicology.

This shift is particularly evident in the number of in vitro tests on skin (irritation/corrosion and sensitization testing) and eye. We also offer an In Chemico assay, Corrositex®, used to assign skin corrosion classifications.

A selection of the suitable test systems often depends on the test compound as well as the regulatory requirements. We would be pleased to advice you in this.

*Performed at RCC - India
**Supported by our European partner (Europe: OECD GLP accredited lab).

RCC conducts in vivo ocular toxicology test using subconjunctival dosing. With an experienced pathology team, we can perform ocular histopathology evaluation.

In addition RCC also offers in vitro bovine corneal opacity and permeability (BCOP) and reconstructed human Cornea-like Epithelium (EPIDerm^TM), which can be used to classify Class 1 chemicals and chemicals not requiring classification for eye irritation or serious eye damage.

The BCOP is an in vitro study which can be used to determine whether a chemical (substance or mixture) should be classified as either causing “serious eye damage” or does not require classification under the Globally Harmonised System for the Classification and Labelling of chemicals.

Ocular irritation test using reconstructed human Cornea-like Epithelium (EPI Ocular^TM) can be used to assess the potential for a substance (such as a cosmetic product, pharmaceutical, chemical or agrochemical) to cause eye irritation when used by the consumer.

*Performed at RCC - India

RCC has a dedicated team of inhalation toxicologists and a state-of-the-art facility to generate powder or liquid atmospheres using flow-past nose exposure system accompanied with imported cascade to determine the particle size distribution to calculate Mass Median Aerodynamic Diameters (MMAD) and Geometric Standard Deviations (GSD).

RCC offers inhalation toxicity testing and related services to efficiently demonstrate the toxicity of test item to support agrochemicals, bio-pesticide, microbial pesticide, industrial chemicals and pharmaceuticals in rodents.

Our extensive expertise in supporting inhalation effects of agrochemical products, industrial chemicals and chemical intermediate for REACH Support and agrochemical registration studies.

RCC offers infusion expertise for your nonclinical services where your drug is intended for vascular administration. Our expertise includes intermittent infusion and slow bolus injection techniques for rodents and non-rodents models using an automated syringe infusion pump.

RCC also offers services to evaluate the potential toxicity effects of your test item on the nervous system.