Registration Dossier

Administrative data

Description of key information

In accordance with column 2 of Reach Regulation (EC) No 1907/2006, Annex VII the skin sensitization study (required in section 8.3) skin sensitization testing was not conducted in animals with HYEQS as the test substance is corrosive. However, HRIP-Testing was performed with preparations of HYEQS demonstrating no skin sensitization potential under known conditions of use.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitization potential of Alkyl dimethyl hydroxyethyl ammonium chloride was assessed in four independent HRIPT (human repeat insult patch) studies. The test item (in a detergent matrix or alternativ as aqueous solution (w/v)) was exposed

on patches to the skin of volunteers in preparation concentrations of at least 0.2 % (w/v) in water up to 0.5 % (w/v) in water. In total 9 inductions were performed. 14 days after final insult patch, treatment sites were challenged and observed 48 and 96 hours after patch. Mild erythema (grade 1) was determined in some of the subjects of the four studies during the challenge. In all four studies there was no evidence that the test item was a sensitizer under the test conditions.

Migrated from Short description of key information:
In accordance with column 2 of Reach Regulation (EC) No 1907/2006, Annex VII the skin sensitization study (required in section 8.3) skin sensitization testing was not conducted in animals with HYEQS as the test substance is corrosive. However, HRIP-Testing was performed with preparations of HYEQS demonstrating no skin sensitization potential under known conditions of use.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Inhalation is no endpoint of concern since inhalation is no critical route of exposure and no peak exposures are to be expected. No animal study was performed.

Justification for classification or non-classification

HRIP-Testing was performed with preparations of Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS) demonstrating no skin sensitization potential under known conditions of use. Therefore, no classification is indicated. No classification for respiratory toxicity is deducible.