Registration Dossier

Administrative data

Description of key information

Oral
LD50 oral >2000 mg/kg bw (Key, Oleon, Clouzeau, 1992, Acute oral, rat, RL2)
Inhalation
LD50 inhalation: > 5100 mg/m3 air (aerosol) (RA-S, CAS 68424-31-7, Key, Croda, Parr-Dobrzanski, 1994, acute tox: inhal, rat, RL2)
Dermal
LD50 dermal: >2000 mg/kg bw (RA-S, CAS 11138-60-6, Key, Exxon, Blanset, 1997, acute dermal, rat, RL2)

Key value for chemical safety assessment

Additional information

Acute Oral toxicity:

An acute oral toxicity study was conducted according to OECD Guideline 401 (Acute Oral Toxicity). Upon treatment of male and female rats with 2000 mg/kg bw of the test substance no mortality or adverse effect was observed during the 14 d observation period. The animals had normal weight gain until the end of the observation period (Key, Oleon, Clouzeau, 1990, Acute oral, rat, RL2). The LD50 value was therefore determined to be > 2000 mg/kg bw.

Acute Inhalation toxicity:

The substance with the CAS No. 68424-31-7 is a structural analogue of CAS No. 57675-44-2 and can therefore be used for read-across (RA-S, CAS 68424-31-7, Key, Croda, Parr-Dobrzanski, 1994, acute tox: inhal, rat, RL2).

Rats were exposed nose only for 4 hours to approx. 5.1 mg/L (analytical concentration of the aerosol of the test material). No mortality occurred and no signs of systemic toxicity were observed. Other effects observed (hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur) were reversible. Body weight gain and lung weight were within normal limits and there were no treatment related gross pathological findings.

Acute Dermal toxicity:

The semiocclusive application of 2000 mg/kg bw for 24 h (according to OECD 402) did not cause any adverse effects in rats expect for a initial reduction of body weight gain implicating that CAS No. 11138-60-6 is not acute toxic if applied on skin (RA-S, CAS 11138-60-6, Key, Exxon, Blanset, 1997, acute dermal, rabbit, RL2).

Justification for classification or non-classification

According to the criteria of the DSD and CLP regulation, no classification is required.

The substance with the CAS No. 57675-44-2 (2-ethyl-2-[[(1-oxooleyl)oxy]methyl]-1,3-propanediyl dioleate) is not acute toxic.