Registration Dossier

Administrative data

Description of key information

No study is available for the target substance, but four acute oral toxicity studies and one acute dermal toxicity study in rats are available performed with the partially unsaturated TEA-Esterquat. Here, the oral LD50 was determined to be > 5000 mg/kg bw in rats. The dermal LD50 was > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
EU Method B.1 (Acute Oral Toxicity)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
OECD Guideline 402 (Acute Dermal Toxicity)

Additional information

oral

In an acute oral toxicity study (according to EU Method B 1), 5 Sprague-Dawley rats/sex/dose were given single oral doses of 2000 or 5000 mg/kg bw of the “partially unsaturated TEA-Esterquat” (89.6 % a.i.) and observed for 14 days. No animal died. No clinical signs or effects on body weight were observed at 2000 mg/kg bw. Hypokinesia was noted only in the treated males at the dose level of 5000 mg/kg bw, 30 minutes and one hour after treatment, then in all the animals after 2 and 4 hours. From day 2 to day 15, no clinical signs were observed at the dose level of 5000 mg/kg bw. These findings were accompanied by a slight slowed down of the body weight gain between day 1 and day 5 in the males at 5000 mg/kg bw. Normal weight gain was observed in the female 5000 mg/kg bw group. Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings. The oral LD50 for males and females is > 5000 mg/kg bw (nominal).

These findings were supported by three additional reliable studies in the rat according to OECD guideline 401. Animals were treated with partially unsaturated TEA-Esterquat at single oral doses of 2000 mg/kg bw in two studies and in one study with 2000 and 5000 mg/kg bw, respectively, and observed for 14 days. In none of these studies mortality, relevant clinical signs or effects on body weight were observed. Gross pathological examinations at terminal necropsy revealed no test article-dependent findings in neither of the studies. The partially unsaturated TEA-Esterquat is considered to be practically non-toxic based on the oral LD50 of > 5000 mg/kg bw (nominal).

 

dermal

In an acute dermal toxicity study according to OECD guideline 402, 5 male and 5 female young adult CD rats were dermally exposed to the partially unsaturated TEA-Esterquat suspended in water for 24 hours under an occlusive dressing to approx. 10 % of body surface area at doses of 2000 mg/kg bw. Animals then were observed for 14 days. No mortality occurred in this limit test. No clinical signs were observed. No macroscopic changes were noted at gross pathological examinations at terminal necropsy. Normal weight gain was observed, except for one female rat. Its body weight gain was slightly reduced. The partially unsaturated TEA-Esterquat is practically non-toxic based on the dermal LD50 of > 2000 mg/kg bw determined in this study.

In conclusion the oral and dermal LD50 for TEA-Esterquat is assessed to be > 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The acute oral and dermal LD50 was greater than 2000 mg/kg bw for all TEA-Esterquats. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/ 776.