Registration Dossier

Administrative data

Description of key information

The available data suggests that amides, C12-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) indicates a low potential for acute oral (LD50 >3,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw) based on the read-across approach.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw
Quality of whole database:
Sufficient data is available to evaluate this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Sufficient information is available on read-across substance.

Additional information

Oral

In two acute oral toxicity OECD guideline studies, single dose levels of 2,000 mg/kg bw and 3,000 mg/kg bw of structurally similar amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) were administered to rats, resulted in no mortalities, no signs of systemic toxicity, no abnormalities or macroscopic changes in the organs at necropsy. The oral LD50 of the substancewas established to be > 2,000 mg/kg bw in Sprague-Dawley CD rat (Hempstock C, 1996) and > 3,000 mg/kg bw in Bor:WISW (SPF TNO) rat (Mürmann P, 1988a). Both studies suggest that amides, C8-18 and C18-unsatd., N-(hydroxyethyl) has low acute oral toxicity when administered via the oral route.

Dermal

A single application of 2,000 mg/kg bw of structurally similar amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl) to abraded and intact skin of rabbits resulted in no mortalities. All animals appeared normal throughout the 24 hours of exposure and the 14 day post-exposure observation period. In two females with abraded skin, weight loss was noted over the 14 day post-exposure period. All remaining rabbits gained weight through to Day 14. The dermal LD50 was determined to be > 2,000 mg/kg bw indicating low acute dermal toxicity (Palanker AL, 1976).

Inhalation

The substance is a solid with a low vapour pressure. Due to its physical state and physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) are created under particular conditions (e.g., spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.


Justification for selection of acute toxicity – oral endpoint
Good quality study.

Justification for selection of acute toxicity – dermal endpoint
One good quality study is available on a read-across substance.

Justification for classification or non-classification

The available data indicates a low potential for acute toxicity (oral and dermal LD50of > 2,000 and > 3,000 mg/kg bw, respectively). The substance does not meet the requirement for classification according to EC (67/548/EEC) and CLP (EC 1272/2008) criteria.