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1.0.: Introduction

▼M10
1.0.1. The objectives of the human health hazard assessment shall be to determine the classification of a substance in accordance with Regulation (EC) No 1272/2008; and to derive levels of exposure to the substance above which humans should not be exposed. This level of exposure is known as the Derived No-Effect Level (DNEL).
1.0.2. The human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribution and elimination) of the substance and the following groups of effects:
(1) acute effects such as acute toxicity, irritation and corrosivity;
(2) sensitisation;
(3) repeated dose toxicity; and
(4) CMR effects (carcinogenity, germ cell mutagenicity and toxicity for reproduction).

Based on all the available information, other effects shall be considered when necessary.
▼C1
1.0.3. The hazard assessment shall comprise the following four steps:

Step 1

:

Evaluation of non-human information.

Step 2

:

Evaluation of human information.

Step 3

:

Classification and Labelling.

Step 4

:

Derivation of DNELs.
1.0.4. The first three steps shall be undertaken for every effect for which information is available and shall be recorded under the relevant section of the Chemical Safety Report and where required and in accordance with Article 31, summarised in the Safety Data Sheet under headings 2 and 11.
1.0.5. For any effect for which no relevant information is available, the relevant section shall contain the sentence: ‘This information is not available’. The justification, including reference to any literature search carried out, shall be included in the technical dossier.
1.0.6. Step 4 of the human health hazard assessment shall be undertaken by integrating the results from the first three steps and shall be included under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under heading 8.1.