Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
Acute inhalation toxicity
With respect to the risk assessment of the use of the registration substance, the endpoint acute toxicity via inhalation is of no relevance:
a) The registration substance is solid at room temperature. Upon heating it undergoes decomposition at 220-240 °C without melting. The vapor pressure is very low (7.0 x 10-5 Pa at 20°C, calculated). Exposure to gaseous form is of no relevance.
b) The registration substance is manufactured in entirely closed system and the formulation occurs under industrial setting. No significant exposure of workers to airborne particles can be reliably derived. Further, the registration substance is corrosive to eye, indicating corrosivity to mucosal tissues. It is likely that the workers exposed accidentally to the airborne particles would immediately take actions to stop the exposure.
c) The registration substance is used solely as cosmetic ingredient for fluid products to be used dermally for the consumers. No spray application is known for the registrant. For the consumer safety the inhalation route is of no relevance.
With respect to the inhalation exposure no concern can be reliably derived for the risk assessment for workers and consumers.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion