Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Effects upon inhalation of the substance were not investigated. This is not required as repeat-dose toxicity was assessed by oral route, the substance is non-volatile (vapour pressure of 6.66 x 10-5 Pa) and the granulometry of the substance (only 0.7% of particles are smaller than 1 mm as the substance is in the form of pellets or flakes) would lead to negligible exposure of terminal airways.
Executive summary:

Effects upon inhalation of the substance were not investigated. This is not required as repeat-dose toxicity was assessed by oral route, the substance is non-volatile (vapour pressure of 6.66 x 10-5 Pa) and the granulometry of the substance (only 0.7% of particles are smaller than 1 mm as the substance is in the form of pellets or flakes) would lead to negligible exposure of terminal airways.