Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
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
other:

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Effects upon inhalation of the substance were not investigated. this is not required as acute toxic potential was investigated for two other routes (oral and dermal), the substance is non volatile (vapour pressure of 1.19x10-3 Pa) and the granulometry of the substance (only 0.2% of particles are smaller than 100micrometer as the substance is in the form of pearls) would lead to negligeable exposure of terminal airways.
Executive summary:

Effects upon inhalation of the substance were not investigated. this is not required as acute toxic potential was investigated for two other routes (oral and dermal), the substance is non volatile (vapour pressure of 1.19x10-3 Pa) and the granulometry of the substance (only 0.2% of particles are smaller than 100micrometer as the substance is in the form of pearls) would lead to negligeable exposure of terminal airways.