Registration Dossier

Administrative data

Description of key information

The available data on the read-across substance: structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) indicates a low potential for acute oral (LD50 > 5,000 mg/kg bw) and dermal toxicity (LD50 > 2,000 mg/kg bw) of amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Two good quality studies available and is sufficient 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 data is available to evaluate this endpoint based on the adopted read-across approach.

Additional information

Oral

Two acute oral toxicity OECD Guideline studies were conducted on structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl). The test substance was administered to groups of Sprague-Dawley CD rats in a single dose of either 2,000 and 5,000 mg/kg bw. No mortalities were observed and no signs of systemic toxicity, abnormalities or macroscopic changes in the organs at necropsy were reported. The oral LD50of amides, C8 -18 and C18-unsatd., N,N-bis(hydroxyethyl) in each study was > 2,000 mg/kg bw (Hempstock C 1996) and > 5,000 mg/kg bw (Skydsgaard K, 1985), respectively. These data suggest a low potential for acute toxicity of amides, C12-18 (even nuymbered) and C18-unsatd., N,N-bis(hydroxyethyl) via the oral route.

Dermal

A single application of 2,000 mg/kg bw of structurally similar amides, C8-18 and C18-unsatd., N,N-bis(hydroxyethyl) to the abraded and intact skin of rabbits resulted in no mortality. All animals appeared normal throughout the 24 hour exposure period and during the 14 day post-exposure observation period. The dermal LD50was therefore > 2,000 mg/kg bw (Palanker AL, 1976). Based on these results amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) is expected to have low potential for acute dermal toxicity.

Inhalation

Due to the physical-chemical properties (i.e. low vapour pressure and high viscosity) of amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), exposure via inhalation is not expected to occur under the conditions of normal and foreseeable handling and use. Therefore toxicity in humans from acute inhalation exposure to amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) is considered unlikely.


Justification for selection of acute toxicity – oral endpoint
One key study available.

Justification for selection of acute toxicity – dermal endpoint
Good quality study on read-across substance.

Justification for classification or non-classification

The available data indicates a low potential for acute toxicity following exposure to C12-18 and C18-unsatd., N,N-bis(hydroxyethyl) (oral and dermal LD50of > 5,000 and > 2,000 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.