Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, 8.6.1 (short-term repeat dose toxicity). Column 2, testing by the inhalation route is appropriate if exposure of humans via inhalation is 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. The substance has a low measured vapour pressure of 7.9 x 10-6 Pa at 25°C and is not considered to be volatile (predicted negative for explosive and oxidising properties). It is considered that the substance has low potential to become airborne from the aqueous preparations in which the substance is used. The potential for exposure to humans to aerosols, particles or droplets of an inhalable size is considered unlikely based on the vapour pressure and use of the substance. Therefore, inhalation is not considered a significant route of exposure as the substance is not available as a vapour. A study has therefore not been conducted via this route. Repeated dose toxicity testing has been instead conducted via the oral route.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion