1. Learning outcomes

    After taking the modules in this elearning course, you will be able to:

    MODULE 01 - Introduction to toxicology

    • Define the term toxicology
    • Describe the different ways in which chemicals can cause harm
    • Explain the impact that physical forms can have on toxicity and exposure.

    MODULE 02 - How to assess for toxicity

    • Define the terms In vitro, ex vivo, in vivo
    • Explain what is meant by the term “alternative methods” and how the 3R’s form part of these
    • Outline the sections of the REACH Regulation which encourage the use of alternatives
    • Describe what other non-animal alternatives are available for finding test data
    • Explain what is meant by in vivo studies and two of the main issues regarding their use

    MODULE 03 - Risk, hazard and exposure

    • Define the terms risk, hazard and exposure
    • Describe the three main routes of exposure and the significance to toxicity

    MODULE 04 - Dose response effects

    • Define the term dose and response
    • Draw a “typical” dose response curve and describe the key parts
    • Explain what is meant by the term “threshold”
    • Explain the difference between thresholded and non thresholded effects with examples
    • Define the terms NOAEL and LOAEL

    MODULE 05 - Irritation and corrosion

    • Define the terms Local effect, irritant and corrosive
    • Explain what is meant by irritant contact dermatitis and how it typically occurs

    MODULE 06 - Toxicokinetics

    • Explain the common testing methods that are used to detect chemical corrosives and irritants
    • Outline the REACH requirements in relation to this endpoint
    • Define the term toxicokinetics
    • Explain what happens at each of the respective stages; absorption, distribution, metabolism and excretion
    • Outline the REACH requirements in relation to toxicokinetics

    MODULE 07 - Acute toxicity

    • Define the term acute toxicity and explain how it differs to repeated dose toxicity
    • Explain why it is not possible to use acute toxicity data to predict repeated dose effects
    • Describe the common testing strategies that can be used to assess acute toxicity
    • Outline the REACH requirements in relation to this endpoint

    MODULE 08 - Repeated dose toxicity (target organ effects)

    • Define the term “systemic effect “and target organ effect with examples
    • Explain the different types of repeated dose studies and the basic differences between these
    • Describe the common testing strategies that are used for repeated dose toxicity
    • Outline the REACH requirements in relation to this endpoint.

    MODULE 09 - Carcinogens

    • Define the terms Carcinogenicity, Benign and malignant tumours, Genotoxic and non genotoxic carcinogens
    • Outline the steps in carcinogenesis
    • Describe the common causes of cancer
    • Describe the common testing strategies for detecting chemical carcinogens
    • Outline the REACH requirements in relation to this endpoint

    MODULE 10 - Genetic toxicology

    • Explain the differences between DNA, genes and chromosomes
    • Define the terms mutagenicity and genotoxicity
    • Describe the types of effects that can occur (on genes, chromosomes and DNA itself) as a result of chemical exposure
    • Explain the significance of genetic toxicology and its relationship with carcinogenesis
    • Describe the common testing approach and methods that are used for genetic toxicology
    • Outline the REACH requirements in relation to this endpoint

    MODULE 11 - Reproductive and developmental effects

    • Define the terms reproductive toxicology and developmental effects
    • Give examples of common adverse effects that are typical of reproductive or developmental toxins
    • Outline the common testing strategies that are used to investigate such effects
    • Outline the REACH requirements in relation to this endpoint

    MODULE 12 - Chemical allergies

    • Describe how an allergy develops
    • Define the term allergic contact dermatitis
    • Explain the difference between allergic contact dermatitis and irritant contact dermatitis
    • Define the terms respiratory hypersensitivity, occupational asthma and work related asthma
    • Explain the significance of developing an allergy to a chemical in the work place
    • Outline the common testing methods used to detect respiratory and skin sensitisers
    • Outline the REACH requirements in relation to this endpoint


    • Define the term adverse outcome pathways (AOP)
    • Identify the three main pieces of information which is required to develop an AOP
    • Explain the usefulness of AOP in toxicology
    • Identify two current issues related to the use of AOP

    MODULE 13b - EMERGING CONCEPTS – Combined effects

    • Explain the current issues related to toxicity testing for mixtures
    • Describe what is meant by the terms additive, synergistic, antagonistic and potentiation
    • Outline the approaches currently taken in Europe when considering combined effects

    MODULE 13c - EMERGING CONCEPTS – Endocrine disruptors

    • Describe what is meant by the endocrine system and its function within living organisms
    • Explain the term “endocrine disruptor” and “endocrine active” substances
    • Describe what is meant by “low dose effects” and “non monotonic dose response”
    • Explain how endocrine disruptors are dealt with under the Reach Regulation
    • Outline the key issues related to the assessment of endocrine disruptors

    MODULE 13d - EMERGING CONCEPTS - Nanoparticles

    • Explain what is meant by the term “nanoparticle”
    • Give two examples of nanomaterials
    • Outline the current key issues related to nanoparticles
    • Explain how nanoparticles are dealt with under REACH

    MODULE 14 - Toxicology & REACH

    • Define the term DNEL and explain the different types which may be derived
    • Outline the process for deriving a DNEL
    • Explain what is meant by risk characterisation and the difference between quantitative and qualitative risk characterisation
    • Explain the different approaches that can be taken with regards to exposure modelling and the difference between a Tier 1 and Tier 2 model
    • Define the term risk characterisation ratio and its significance
    • Describe the difference between the extended safety data sheet and a safety data sheet and when these documents need to be made available
    • Describe the changes which the introduction of the CLP Regulation has had on the duties of suppliers within Europe
    • Define the term “CMR” and “PBT” and the implications under REACH

    MODULE 15 - Toxicological Testing Requirements and REACH

    • Describe the underlying principle behind REACH in the context of human health
    • Describe where the human health endpoints are listed in the REACH Regulation and explain why as the tonnage being placed on the market increases so does the testing requirements
    • Explain what is meant by standard information requirements and where these can be located within the REACH REGULATION
    • Explain the kind of information that can be derived from Column 2 to the standard information requirements
    • Explain what kind of information can be obtained from Annex XI
    • Define the terms “Adaptation” , “Data Waiver”, “weight of evidence”, “exposure based waiving” AND “read across”