Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

In the key study, i.e. an acute oral toxicity study according to the Acute Toxic Class Method, doses of 2000 and 300 mg/kg bw of the main constituent 4,8,11 -dodecatrienal (undiluted or preparations in corn oil Ph.Eur.) were administered by gavage to three test groups of three fasted Wistar rats each (2000 mg/kg bw in 6 females and 300 mg/kg bw in 3 females).

The following test substance-related clinical observations were recorded, clinical signs occurred within the first 4 hours after administration:

Experiments were conducted with 3 test groups (1st and 2nd test group for 2000 mg/kg bw, 3rd test group 300 mg/kg bw)

2000 mg/kg (first test group):

- No mortality occurred

- No clinical signs were observed

2000 mg/kg (second test group):

- No mortality occurred

- Impaired general state in all animals

- Dyspnoea in all animals

- Piloerection in all animals

- Cowering position in all animals

300 mg/kg (single test group):

- No mortality occurred

- No clinical signs were observed

All animals gained weight in a normal range throughout the study period.

There were no macroscopic pathological findings in any animal sacrificed at the end of observation period (9 females).

The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

The constituent 4,8-Cyclododecadien-1-one was found to be virtually non-toxic in an acute oral toxicity study in rats acc. to OECD TG 423 and GLP (BASF 2016; 10A0306/15X086). A LD50 >2000 mg/kg bw was determined.

Justification for classification or non-classification

The present data on acute oral toxicity of the main constituent 4,8,11-Dodecatrienal do not fulfill the criteria laid down in regulation (EU) 1272/2008. Furthermore, acute oral toxicity data with the constituent 4,8-Cyclododecadien-1-one do not fulfill the criteria laid down in regulation (EU) 1272/2008. Thus, based on the current data for the these two components (representing 55% to 95% of the reaction mass) a non-classification of the registered substance is warranted.