Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REACH Annex XI, the conduct of an acute inhalation toxicity study is scientifically unjustified. The test substance has a low vapor pressure, so the potential for the unintended generation of inhalable forms such as dust or aerosols is low. The most likely route of human exposure for workers and consumers is the dermal route. However,small quantities of the TEA-Esterquats are manufactured into spray (product) applications for professional and consumer uses. For spray applications, the concentration of diluted preparations for use is ≤ 0,5% active ingredient (worst case). Results of laboratory animal studies show a very low acute toxicity after oral or dermal exposure. Therefore the acute intrinsic toxic activity of the TEA-Esterquats is considered to be very low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion