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Description of key information

Four acute oral toxicity studies and an acute dermal toxicity study in rats are available performed with the partially unsaturated TEA-Esterquat.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

In an acute oral toxicity study (EU Method B.1 (Acute Toxicity (Oral), 5 male and 5 female Sprague-Dawley rats were given single oral doses of 2000 and 5000 mg/kg bw of partially unsaturated TEA-Esterquat and were observed for 14 days.

No animal died. No clinical signs or effects on body weight were observed at the dose level of 2000 mg/kg bw.A slight decrease in the spontaneous activity of the animals treated at the dose level of 5000 mg/kg bw was observed for a few hours after treatment and was accompanied with a slightly reduced body weight gain (day 1 to day 5) in males. From day 2 to day 15, the general behaviour was not influenced by the treatment.Gross pathological examinations at terminal necropsy revealed no test article-dependent findings at any dose level.

The oral LD50for partially unsaturated TEA-Esterquat was determined to be > 5000 mg/kg bw (nominal) and > 4480 mg/kg bw (based on a.i.), respectively in this study.

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 LD50of > 5000 mg/kg bw (nominal).

 

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 LD50of > 2000 mg/kg bw determined in this study.

Discussion:

Human data on the acute toxicity of TEA-Esterquats are not available.

 

In rats the partially unsaturated TEA-Esterquat is practically non-toxic with an oral LD50of > 5000 mg/kg bw (nominal).

The dermal LD50was determined to be > 2000 mg/kg bw based on data from the partially unsaturated TEA-Esterquat.

The NOAEL for acute oral toxicity in the rat is 2000 mg/kg bw.

The NOAEL for acute dermal toxicity in the rat is 2000 mg/kg bw.

 

In conclusion the oral and dermal LD50for all TEA-Esterquat is assessed to be > 2000 mg/kg bw. 

Justification for classification or non-classification

The oral LD50of all TEA-Esterquat was assessed to be > 2000 mg/kg bw.

The dermal LD50was assessed to be > 2000 mg/kg bw for all TEA-Esterquats, based on the result of the partially unsaturated TEA-Esterquat. Taking into account a worst case dermal absorption rate of 2 %, the expected dermal LD50value might even be higher than the oral one.

 For neither route of administration a statistically based LD50value could be derived as no substance-related mortalities occurred at or below the maximum concentration tested.

 

According to Directive 67/548 EEC as well as GHS Regulation EC No 1272/2008, none of the TEA-Esterquats need to be classified or labelled.