Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
If no dermal tox study exists and is waived: According to Annex VIII, Section 8.5, Column 2, of Regulation EC No. 1907/2006, a toxicity study, in addition to the acute oral toxicity study, under 8.5.2 to 8.5.3 shall be provided for at least one other route. Commission Regulation (EU) 2016/863 amends this data requirement, stating that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. The risk of acute toxicity by the dermal route has been addressed in light of an acute oral toxicity study with a LD50 > 2000 and no systemic toxicity observed in other in vivo studies. It is determined that testing for acute dermal toxicity is not scientifically indicated. The criteria for satisfaction of Sections 8.5.2 and 8.5.3 are met and the data requirement for an acute toxicity study by a third route, inhalation, is waived.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion