The OECD has issued guidance on when it might be acceptable to waive testing for acute oral, dermal and inhalation toxicity, skin and eye irritation, and skin sensitisation. The document is aimed at parties tasked with reviewing data for the purposes of classification and labelling or those responsible for generating acute toxicity data.

Waivers are generally considered when there is minimal human exposure by a particular route, or when it is technically not possible to perform a study for a certain endpoint. One example of this described by the OECD is in relation to chemicals that cannot be physically inhaled (e.g. substances of low volatility with large particle sizes), in which the acute inhalation toxicity test may be waived. In addition, animal studies should be waived if it is possible to draw conclusions from valid in vitro tests or from alternative non-testing approaches such as read-across and (Q)SAR analysis.

ECHA has produced an overall practical guide (PG) on the use of alternatives to animal testing, which brings together its previous PGs on the use of in vitro data (PG1), weight-of-evidence approaches (PG2), data waiving (PG4), read-across (PG6) and the avoidance of unnecessary testing on animals (PG10). The PG on how to use and report (quantitative) structure-activity relationships, (Q)SARs, has also been updated.

This accompanies two reports from ECHA that provide specific advice on the use of new or revised in vitro test methods to address a chemical’s potential to cause local toxicity to the skin or eye. ‘Alternative’ assays (rather than tests on laboratory animals) are now the default requirement for assessments of these endpoints. An update in the REACH regulatory text regarding the use of alternative methods for skin sensitisation is also expected to come into force in Autumn 2016. Registrants are encouraged to consider such testing strategies now in time for the 2018 REACH deadline.

Organisation for the Economic Co-operation and Development (2016). Environment Directorate Joint Meeting of the Chemicals Committee and the Working Party On Chemicals, Pesticides and Biotechnology. Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests. Series on Testing & Assessment No. 237. ENV/JM/MONO(2016)32. 02 August 2016.

European Chemicals Agency (2016).
How to use alternatives to animal testing to fulfil your information requirements for REACH registration.

How to use and report (Q)SARs.

How to use new or revised in vitro test methods to address serious eye damage/eye irritation – a testing and assessment strategy.
How to use new or revised in vitro test methods to address skin corrosion/irritation – a testing and assessment strategy.

Registrants to use alternative test methods for skin sensitisation. ECHA/NI/16/32.


The above items were taken from the August/September 2016 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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