Division 3.3.1 Toxicological risk assessment for user/worker safety

Risks to workers shall be assessed in a series of studies using the additive in the form for which the application has been submitted. Acute inhalation toxicity studies shall be performed unless the product is unlikely to form a respirable dust or mist. Studies on skin irritancy must be performed, and if these give negative results, mucous membrane (e.g. eye) irritancy shall be assessed. Allergenic potential/skin sensitisation potential shall also be assessed. The toxicity data generated to meet consumer safety (see 3.2.2) shall be used to assess the potential systemic toxicity of the additive. All these shall be assessed, if necessary, by direct measurement and specific studies.