Amines, N-tallow alkyltrimethylenedi-, propoxylated

Endpoint summary

Description of key information

The acute oral toxicity of the substance was assessed using:
- an acute oral toxicity test performed in rats according to a method similar to OECD 401 guideline. Very few information on the tested substance were reported and only male rats were used in the study (Gobron, 1981a).
Based on this study, the substance is of moderate acute toxicity following oral exposure:
The oral LD50  was 1255 mg/kg bw in male rats.
No dermal and inhalation toxicity studies were performed on the substance due to its corrosive properties. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

1 255 mg/kg bw

Additional information

Acute Oral Toxicity:

One study was reported for the acute oral toxicity endpoint and was selected as a key study. The study of Gobron (1981a) was reliable with restrictions as very few information on the tested substance were reported and only male rats were used.

In this study, the acute oral toxicity of the test item was evaluated according to a method similar to OECD guideline 401 and in compliance with the principles of Good Laboratory Practice Regulations.

The test item was administered undiluted by oral route (gavage) to groups of ten male fasted Sprague-Dawley rats. In the preliminary experiment, the test item was administered at the dose-levels of 1, 3,4, 5, 10, 15, 20 and 25 mL/kg bw (relative density 0.897) and the animals were observed for 7 days. Based on these results, the dose-levels selected for the main experiment were 0.5, 1.0, 1.5, 2.0 and 3.0 mL/kg bw of the undiluted test item.

Clinical signs, mortality and body weight were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy. The LD50 was calculated according to Litchfield & Wilcoxon (J. Pharmacol. Exp. Therap., 1949, 96, 99-113).

No deaths occured at 0.5 ml/kg bw. At 1, 1,5 and 2ml/kg bw, 2, 4 and 9 rats died from day 4 to day 7 respectively. At 3 ml/kg bw, all rats died on day 4.

Generally clinical signs were drowsiness and mucoid diarrhoea (at 1 mL/kg bw and higher), prostration and piloerection (at 1.5 ml/kg bw and higher), abdominal swelling and dizziness (at 3 ml/kg bw). no clinical sighns were observed at 0.5 ml/kg bw.

No macroscopic abnormalities were observed at necropsy in any dose-groups.

Under these experimental conditions, the oral LD50 of the test item was 1255 (1031 - 1534) mg/kg bw in male rats with 95% confidence interval limits.

Acute dermal Toxicity:

The substance is classified as corrosive and testing for acute toxicity is therefore not needed according to REACH regulation (EC) 1907/2006 (Annex VII, point 8.5, column 2).

Acute inhalation Toxicity:

The substance is classified as corrosive and testing for acute toxicity is therefore not needed according to REACH regulation (EC) 1907/2006 (Annex VII, point 8.5, column 2). Additionally, based on the low vapour pressure of the substance a significant risk concerning inhalation is not anticipated.

Justification for classification or non-classification

Based on the results of the study conducted by Gobron (1981a) and according to the criteria laid down in EU directive67/548/EEC, the substance is

classified Harmful with the risk phrase R22

According to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP), the substance is classified in category 4 of toxicity with the hazard statement H302.

The substance is classified as corrosive to skin and testing for acute toxicity is therefore not needed according to REACH regulation (EC) 1907/2006 (Annex VIII, point 8.5, column 2).

Due to the low vapour pressure of the substance, exposure to either aerosols or fumes of the substances is unlikely. Therefore no classification for acute inhalation toxicity is deemed necessary according toEU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC.