Registration Dossier

Administrative data

Description of key information

The acute oral median lethal dose (LD50) of  Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS), to the Sprague-Dawley strain rat was found to be greater than 200 mg/kg body weight but less than 2000 mg/kg bodyweight (nominal concentration). The study was performed with a 35% (w/v) solution in water according to OECD 401. In a second study (up and down method according to OECD 425) with an analogue quaternary ammonium compound (C13-15 dimethyl hydroxyethylammonium chloride) which is similar in structure (for Read across justification refer to IUCLID section 13, Assessment reports), the LD50 was determined to be 1300 mg/kg bw (nominal concentration). The active ingredient /purity of this substance were approx. 30 % (w/v) solution in water.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
1 000 mg/kg bw

Additional information

The acute oral median lethal dose LD 50 (acute oral toxicity) of Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS) to the Sprague-Dawley strain rat was determined to be greater than 200 mg/kg body weight but less than 2000 mg/kg bodyweight (nominal concentration). It was performed in an OECD 401 study with a 35% (w/v) solution in water. In a second independent trial (up and down method acc. to OECD 425) the LD 50 was determined to be 1300 mg/kg bw (nominal concentration). This study was performed with a similar quaternary ammonium compound of approx. 30 % (w/v) solution in water (For Read-across justification refer to IUCLID section 13, Assessment reports).

In accordance with column 2 of Reach Regulation (EC) No 1907/2006 Annex VIII the acute dermal toxicity study and the acute inhalation toxicity study (required in section 8.5) does not need to be conducted as the test substance is corrosive to the skin. Furthermore, inhalation is no endpoint of concern since inhalation is no critical route of exposure and no peak exposures are to be expected.

Justification for classification or non-classification

Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS) has to be classified with regard to acute oral toxicity as "Xn, R22, harmful if swallowed" according to DSD (Dangerous Substance Directive). According to Regulation (EC) No 1272/2008 of the European Parliament and of the Council,16 December 2008 (CLP or GHS (Global harmonized System for classification, labeling and packaging) an LD50 cut-off value of 1000 mg/kg bw is established. Based hereupon HYEQS has to be classified with regard to acute oral toxicity in "Cat 4 oral (>300 – 2000)". This cut-off value of 1000 mg/kg is revealed when using the individual data from the OECD 401 study and applying the evaluation scheme in Annex 2d of the OECD test guideline 423. No classification for acute dermal and acute inhalation toxicity is deducible.

 

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