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Toxicological data requirements (2/2)


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Fulfilling toxicological data requirements

According to REACH annexe VI, the registrant should gather and evaluate all available information. This includes physico-chemical properties, human data, in vitro and in vivo testing data and non testing data (i.e. data obtained with (Quantitative) Structure Activity Relationship ((Q)SAR) models, substance grouping, read across, etc.). Information sources comprise in house company and trade association files, databanks of compiled data, published literature, internet search engines, and (Q)SAR models. An indicative list of available databases and databanks is provided, adapted from the Guidance on information requirements under REACH. Furthermore, information on exposure, use and risk management measures should also be collected and evaluated. The information search strategy should be recorded in the registration dossier.
If data are considered inadequate for hazard and risk assessment, further testing should be carried out in accordance with the requirements in REACH annexe VII (substances imported/manufactured ≥ 1 tonne per year) and VIII (≥ 10 tonnes per year), and should be proposed in accordance with the requirements in REACH annexe IX (≥ 100 tonnes per year) and X (≥ 1000 tonnes per year). For more details, see Information requirements for registration and Scheme to fulfill information requirements. For each toxicological endpoint, a sequential testing strategy is recommended for developing adequate and scientifically sound data for assessment and classification of substances. Tests on substances shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate. The testing strategy shall take into account specific rules that allow deviating from the standard testing regime (column 2 of annexes VII to X). Moreover, the standard testing regime can be adapted by the rules laid down in annexe XI, e.g. that allow avoiding unnecessary animal testing. New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted. The Guidance on information requirements under REACH provides assistance for integrated testing strategies.
The following table presents, for each toxicological endpoint, the REACH annexes in which the information requirements are specified and a link to the standard testing regime diagram and the possible adaptations.

Toxicological endpointREACH annexe concernedDiagram for integrated testing strategy
Skin irritation/corrosion VII - VIIITesting strategy for skin irritation/corrosion
Eye irritation VII - VIIITesting strategy for eye irritation
Skin sensitisation VIITesting strategy for skin sensitisation
Acute toxicity VII - VIIITesting strategy for acute toxicity
Repeated dose toxicity VIII to X Testing strategy for repeated dose toxicity
Reproductive toxicity VIII to XTesting strategy for reproductive toxicity
Mutagenicity VII - VIIITesting strategy for mutagenicity
Carcinogenicity XTesting strategy for carcinogenicity
Toxicokinetics VIII

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Prévention du risque chimique, France, 2007
This document is provided for information only and under no circumstances constitutes legal advice. The only authentic legal reference is the text of the REACH Regulation (Regulation (EC) n° 1907/2006).