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Administrative data

Description of key information

One study for acute oral toxicity in rats is available  with the oleic acid-based TEA-Esterquat.
Furthermore, there is an acute dermal toxicity study in rats available performed with the partially unsaturated TEA-Esterquat.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

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

Additional information

In an acute oral toxicity study (EU Method B.1 bis, Acute Oral Toxicity - Fixed Dose Procedure), 5 male and 5 female Sprague-Dawley rats were given a single oral dose of 2000 mg/kg bw of oleic acid-based TEA-Esterquat and were observed for 14 days.

No animal died. No clinical signs or effects on body weight were observed. Gross pathological examinations at terminal necropsy revealed no test article-dependent findings.

The oleic acid-based TEA-Esterquat is practically non-toxic based on the oral LD50of > 2000 mg/kg bw (nominal) determined in this study.

 

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 substance oleic acid-based TEA-Esterquat is practically non-toxic with an oral LD50of > 2000 mg/kg bw.

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

 

The molecular structure of all TEA-Esterquats is almost identical; they possess common functional groups and precursors. The only difference is the origin of used fatty acid moiety, resulting in variation of the chain-length distribution and degree of saturation (refer to chapter 1.1.2).

The difference in the fatty acid moiety is assessed to be of no toxicological relevance for the oral route of administration, as there is no different acute toxicity profile observed in studies with the partially unsaturated and oleic acid-based TEA-Esterquat at doses of 2000 mg/kg bw.

Based on skin irritation data for the dermal administration of the oleic acid-based TEA-Esterquat a higher level of irritation can be expected on the basis of skin irritation data. Due to the very low dermal absorption rate of maximal 2 % of the whole Esterquat group (described in section 5.1) and the results of the acute oral toxicity study with the oleic acid-based TEA-Esterquat, showing no systemic effects at the highest dose of 2000 mg/kg bw, there is no indication suggesting that the oleic acid-based TEA-Esterquat might have an acute dermal toxicity profile different from the other TEA-Esterquats. Therefore, a read-across from the partially unsaturated TEA-Esterquat is judged to be acceptable.

 

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.