Division CRITERIA FOR CLASSIFICATION OF TEST SUBSTANCES WITH EXPECTED LD50 VALUES EXCEEDING 2000 MG/KG WITHOUT THE NEED FOR TESTING.

Criteria for hazard Category 5 are intended to enable the identification of test substances which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations. These substances are anticipated to have an oral or dermal LD₅₀ in the range of 2000-5000 mg/kg or equivalent doses for other routes. Test substances could be classified in the hazard category defined by: 2000mg/kg <LD₅₀ < 5000mg/kg (Category 5 in the GHS) in the following cases:

1. a))

   if directed to this category by any of the testing schemes of Annex 2, based on mortality incidences

2. b))

   if reliable evidence is already available that indicates the LD⁵⁰ to be in the range of Category 5 values; or other animal studies or toxic effects in humans indicate a concern for human health of an acute nature.

3. c))

   through extrapolation, estimation or measurement of data if assignment to a more hazardous class is not warranted, and

   • reliable information is available indicating significant toxic effects in humans, or

   • any mortality is observed when tested up to Category 4 values by the oral route, or

   • where expert judgement confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhoea, piloerection or an ungroomed appearance, or

   • where expert judgement confirms reliable information indicating the potential for significant acute effects from the other animal studies.