Registration Dossier

Administrative data

sub-chronic toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a sub-chronic toxicity study (90 days) does not need to be conducted because the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day 'limit test' and human exposure is limited
Justification for type of information:
The substance is exclusively produced and used in grease form and has been shown to be non-corrosive in skin and eye irritation studies. It has a low vapour pressure so the potential for the generation of inhalable forms is low, also the use of grease forms will not result in aerosols, particles or droplets of inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The substance has not been tested by the inhalation route. However, an acute oral toxicity study in rats showed evidence of a lack of acute toxicity up to the highest doses tested (2000 mg/kg). Therefore, it is considered that this waiver applies and, in accordance with REACH Regulation, Annex VIII, 8.6.1, column 2 as well as Annex XI, 1, the performance of additional repeat dose toxicity studies is not justified due to exposure as well as toxicological considerations.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion