One of the most important properties to be considered when assessing the potential hazards of a material is the toxicological effect that it may have on the human body. C3-B can look into this effect and provide suitable data necessary to ensure that exposure to a material does not result in detrimental health effects.

There are many ways in which a chemical can enter the body and therefore testing must ensure that different routes of entry such as by mouth (oral), through the skin (dermal), by injection (intravenous) or via the lungs (inhalation) are covered.

As well as looking into the various routes of entry where a chemical can penetrate into the body, it is also necessary to take into account different exposure conditions. Initially it is important to determine whether health effects are observed after a single dose (acute exposure). If effects are observed or larger quantities of material are to be used then it will be necessary to consider prolonged exposure or multiple dose (chronic exposure).

The amount of information required will depend upon the anticipated level of manufacture of the product, from Level VIIC with an annual quantity of > 10 kg, through Level VIIA (often referred to as the Base Set level) to Level 2 with annual quantities > 1000 tonnes. The majority of tests are performed as per Annex V, Part B of the Dangerous Substances Directive 67/548/EEC. Many of the tests are also listed under the proposed REACH scheme.

Toxicological Tests

EU Ref. OECD Ref. Test Description
B1 423 Acute oral toxicity in the rat
B3 402 Acute dermal toxicity in the rat
B4 404 Acute skin irritation in the rabbit
B5 405 Acute eye irritation in the rabbit
B6 406 Skin sensitisation in the Guinea pig
  429 Ex-vivo non-radioactive Local Lymph Node Assay (LLNA) in the mouse
B7 407 28-day oral repeated dose toxicity in the rat

Test Methods are provided by the EU and OECD (Organisation for Economic Co-operation and Development) guidelines, pink pages which are also known as the 400 series.

C3-B is an informal collaboration between AstraZeneca UK Limited (Brixham Environmental Laboratory), Chilworth Technology Limited, Centre de Recherches Biologiques (CERB) and Chemsafe S.a.S. No legal relationship exists between the aforementioned entities and none of them has the authority to contract on behalf of any other of the entities.