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Description of key information

The acute oral toxicity of the substance was assessed using:
- 2 acute oral toxicity tests performed in rats. The study of Dufour was carried out according to OECD 401 guideline and Good Laboratory Practices (Dufour, 1997). The study of Petra was older and conducted according to a method similar to OECD 401 guideline. Very few information on the tested substance were reported (Petra, 1981)
Based on these data, the substance is of moderate acute toxicity following oral exposure:
The oral LD50 was 704 mg/kg bw in 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:
704 mg/kg bw

Additional information

Acute Oral Toxicity:

A LD50 oral (gavage, Sprague-Dawley rat) of 704 (283 - 1312) mg/kg in female rats is reported for Amines, N-C12-18-alkylbis(trimethylene)tri-, reaction products with N-C12-18-alkyltrimethylenediamines and formic acid in the key study of Griffon (2003a) with a reliability score of 1. Typical clinical signs were hypoactivity, piloerection, dyspnea, swollen abdomen and hypersalivation, which are indicative of the irritative/corrosive action of the substance.

A second study with a reliability of 2 is available (Petra,1981) where Sprague Dawley rats have been treated with the undiluted substance via oral gavage. Very few information on the tested substance were reported and a non-monotonous dose response renders this study less reliable. As the reported LD50 is > 2830 mg/kg in male and female rats and thereby higher than the value from the key study, it is disregarded for hazard assessment. No further studies are available.

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 Griffon (2003a) 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 to EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC.