Fatty acids, tall-oil, ethoxylated

Endpoint summary

Description of key information

The acute oral LD50 of the test substance was determined to be > 10000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

340 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

ORAL:

In an acute oral toxicity study performed similar to OECD guideline 401 (BASF 1971), three groups of rats consisting of 10 animals/sex/dose were treated by single gavage application with an aqueous solution of the test substance (10000, 8000,  6400 mg/kg bw). The animals were observed for mortality and for clinical symptoms of toxicity over a period of 7 days. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy. No mortality occurred at the tested concentrations. At all doses mastication, irregular breathing, redness of the eyes and closed eyes were seen immediately after dosing. The next morning mastication and irregular breathing was observed. On the following days, no clinical sings were observed. Pathological examination revealed hydrometra in 3 animals exposed to 10000 mg/kg bw, 2 animals exposed to 8000 mg/kg bw, and 3 animals exposed to 6400 mg/kg bw. Based on the results obtained under the test conditions of this study, the acute oral LD50 was determined to be > 10000 mg/kg bw.

 

In another acute oral toxicity study of similar design four groups of rats consisting of 5 animals/sex/dose were treated by single gavage application with an aqueous solution of the test substance (6400, 3200,  1600, 200  µL/kg). The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy. No mortality occurred at the tested concentrations. At all doses on the day of the experiment, restless behaviour was observed after application. The animals had slightly accelerated breathing as well as ruffled fur. Four days after the application all animals were without clinical signs. In this study no pathological changes in the organs were observed. One animal showed bronchitis and bronchiectasis on both sides.

In an additional study a limit test was performed. 4 rats were treated by single administration with 2000 mg/kg of the test substance (2 animals/sex/dose). During the observation period of 14 days, no clinical symptoms of toxicity or mortality were observed.

 

INHALATION:

To evaluate the potential acute inhalation toxicity of the test substance an Inhalation Risk Test conducted according to a BASF internal testing method (BASF 1971). The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (20 °C). Rats were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder. The animals were exposed for 8 hour. The exposure concentration was estimated to be 0.28 mg/L based on evaporated substance. In addition to mortality, clinical signs were recorded and necropsy on surviving animals performed. No mortality occurred and no clinical sign were noted during exposure and observation period. In one animal exposed for 8 hours hydrometra was observed after necropsy. Since no mortality occurred at the concentrations tested an LC50 estimation cannot be made.

 

In another Inhalation Risk Test of similar design, Rats (12 animals) were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder. This time vapours were generated at 20 °C as well as 50 °C. The exposure concentrations were 0.04 mg/L and 0.34 mg/L. Rats were exposed for 8 hour. As in the previous study, no mortality occurred after exposure up to 8 hours. Clinical sings observed in the animals exposed to the vapor generated at 20°C included mild escape attempts when exposure began and at the end of the exposure period slight eye irritation was observed. The next day, the animals were without symptoms. In the animals exposed to the vapor generated at 50 °C escape attempts were noted in the first 60 minutes of exposure. Exposure to the saturated atmosphere caused slight eye irritation. At the end of the exposure period, all clinical signs were resolved. Since no mortality occurred at the concentrations tested an LC50 estimation cannot be made.

Based on the inhalation studies, no conclusion on LC50 can be drawn, because the tested concentrations are too low in relation to the classification criteria.

Justification for classification or non-classification

Based on the available data, classification for acute oral toxicity is not warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008

Based on the available inhalation studies classification for acute inhalation toxicity in accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not possible.