10 Annex

Survey and safety assessment of Chemical substances in artificial nails and nail hardeners

10.1 Lifetime exposure to formaldehyde

10.1 Lifetime exposure to formaldehyde

As one of the critical effects of formaldehyde is cancer a scenario to calculate the life-time inhalation exposure and risk of formaldehyde by using nail hardeners has been performed.

The following use of nail hardeners has been stated in different product descriptions:

1. Apply one layer on the first day and a second layer on the second day.

2. On the third day remove both layers.

3. Repeat the steps for 14 days.

4. After this 14-days procedure the product should only be used 1-2 times peer week.

5. The 14-day treatment should not be repeated more than 1-2 times a year.

Estimating a life-time exposure based on these instructions of use will result in the following exposure:

2 times x 14 days = 28 times

Rest of the year 2 times peer week: 48 weeks x 2 times/week = 96 times

Each year; maximum of use is: 124 times

As the carcinogenic potential of formaldehyde is expected to be only after inhalation exposure only the assumed percentage of inhalation after use of nail hardeners are used to calculate the total life-time exposure.

Twenty-five percent formaldehyde is expected to evaporate during the drying process. It is assumed that it is released in the close area around the person corresponding to 1 m³.

Exposure of formaldehyde was calculated to be:

Daily exposure_inhalation, formaldehyde:

The mean exposure during a year: 3.125 mg/m³ of apply x (124 times/365 days) = 1.06 mg/m³