Registration Dossier

Administrative data

Description of key information

Oral (OECD 423/EU Method B.1), rats: LD50 > 2000 mg/kg bw (LD50 cut-off value = 2500 mg/kg bw)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study and is thus sufficient to fulfil the standard information requirements set out in Annex VII, item 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: oral

An acute oral toxicity study performed according to OECD TG 423 with (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1) (CAS 17736-08-2) is available (Charles River, 2016). In this limit test groups of three female Wistar Crl:WI (Han) rats were administered a single dose of 2000 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days after administration. 1/6 females was found dead on Day 3 of the study period. Clinical signs such as hunched posture and/or piloerection were noted for the animals between Days 1 and 3. Additionally, lethargy, flat posture, slow breathing, shallow respiration and hypothermia were noted for the animal found dead on Days 1 and/or 2. The mean body weight gain shown by the surviving animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. Gross pathology revealed no toxicologically relevant abnormalities in all animals. Thus, according to OECD 423 TG, the acute oral LD50 cut-off value was considered to be 2500 mg/kg bw.

Justification for classification or non-classification

The available data on acute toxicity of (Z)-N-methyl-N-(1-oxo-9 -octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1) (CAS 17736-08-2) do not meet the criteria for classification according to Regulation (EC) No 1272/2008 (CLP). Data therefore are conclusive but not sufficient for classification.