Tall oil, compd. with ethanolamine

Short-term toxicity to fish

Description of key information

The 96 hour LL50 was > 100 mg/L and the NOELR 100 mg/L based on exposure to a WAF of the test material. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

This endpoint was addressed using a read across approach to structural analogues of the registered substance. Two key studies are provided, one on tall oil and one on ethanolamine. In this respect it is considered that the data submitted provides an adequate reflection of the test material.

 

A limit test was carried out to assess the acute toxicity potential of the read across substance distilled tall oil to Danio rerio in accordance with the standardised guideline OECD 203 under GLP conditions. The study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).

The fish were exposed to a 100 mg/L loading rate WAF of the test material for 96 hours under semi-static conditions. Fish were observed for any effects on mortality and additionally for any sub-lethal and behavioural effects.

No mortality was seen throughout the test period, nor were any sub-lethal effects noted.

Under the conditions of this study, the 96 hour LL50 was determined to be > 100 mg/L and the NOELR to be 100 mg/L based on exposure to a WAF of the test material. No classification of the test material is required in accordance with EU criteria.

 

The second key study investigates the acute toxicity potential of the read across substance ethanolamine to Cyprinus carpio in accordance with Directive 92/69/EEC, C.1 under GLP conditions. The study was assigned a reliability score of 2 in accordance with the criteria of Klimisch (1997).

The fish were exposed to nominal concentrations of 3, 10, 30, 100, 300 and 1000 mg/L for 96 hours under semi-static conditions.

None of the controls or fish exposed to 90 mg/L died. One fish exposed to 150 mg/L died between 72 and 96 hours. Two fish exposed to 280 mg/L died within 72 hours. All fish exposed to 500 and 900 mg/L were dead by 48 and 24 hours, respectively.

The high mortality within the upper concentration range may be attributable to the increased pH (maximum pH 10.2) caused by the test material.

Under the conditions of this study, the 96 hour LC50 of the test material was 349 mg/L (confidence limit 280 to 500 mg/L). The test material requires no classification in accordance with EU criteria.

 

Under the conditions of these studies, neither the tall oil nor ethanolamine component of the test material requires classification for acute toxicity. On this basis, and as a precautionary measure, the overall determination that will be carried forward for risk assessment of the registered substance will be the 96 hour LL50 of > 100 mg/L and NOELR of 100 mg/L based on exposure to a WAF of the test material.