Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Oral

In an acute toxicity test, according to OECD guideline 423, 3 females received 2000 mg/kg bw and 6 females received 300 mg/kg bw Aminopropyl Vinyl Ether under standardized conditions (BASF AG, 2013). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 is >300 and <2000 mg/kg bw for female rats. None of the females in the 300 mg/kg bw dose group died during the observation period, but 3/3 animals of the 2000 mg/kg bw died within hour 0 after administration. Clinical observations in the 300 mg/kg bw administration group: impaired general state, piloerection, pronounced dyspnea, exophthalamos, lacrimation and salivation. Clinical observations in the 2000 mg/kg bw administration group revealed poor general state, pronounced dyspnoea, salivation and piloerection and were observed. The body weight of three animals in both 300 mg/kg dose groups decreased during the first post-observation week, but increased normally during the second post-observation week. At gross necropsy following macroscopic finding were observed in the 2000 mg/kg group: severe swelling of the stomach mucosa, dark red discoloration of the stomach content, extensive bleeding in the glandular stomach and forestomach, dark red discoloration of the small intestine and its content, spotted discoloration of the liver and congestion in the kidneys. No macroscopic pathologic abnormalities were noted at termination of the study in the surviving animals (300 mg/kg bw).

 

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable for the purpose of classification. Therefore Aminopropyl Vinyl Ether has to be classified according to EU: Xn; R22

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are considered reliable and suitable for the purpose of classification. Therefore Aminopropyl Vinyl Ether has to be classified according to GHS: Category 4, H302