Division 3.3.1.1 Effects on the respiratory system

Evidence shall be provided that airborne levels of dust or mist of the additive will not constitute a hazard to the health of users/workers. This evidence shall include, where necessary:

• inhalation tests in laboratory animals;

• published epidemiological data and/or the applicants own data on its work plant and/or irritancy; and

• respiratory system sensitisation tests.

Acute inhalation toxicity studies shall be performed if particles or droplets with a diameter of less than 50 μm constitute more than 1 % on a weight basis of the product.

Protocols for acute inhalation toxicity studies should be in line with OECD Guideline 403. If sub-chronic toxicity studies are considered necessary, they should follow OECD Guidelines 412 (Repeated Dose Inhalation Toxicity: 28-day or 14-day study) or 413 (Sub-chronic Inhalation Toxicity: 90-day study).