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EC number: 263-061-4 | CAS number: 61789-45-5
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No long-term toxicity effects on fish up to the limit of water solubility
Key value for chemical safety assessment
Additional information
For the fatty acid, dehydrated castor-oil (CAS 61789 -45 -5) no data for chronic toxicity effects on fish are available. Therefore ecotoxicological effects are predicted from adequate and reliable data for source substance(s) by read-across to the target substance within the group applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006.
Read-across is performed to docosanoic acid C22 (CAS 112 -85 -6) and to sodium laurate (CAS 629-25-4), which is not a member of the category. The read across of sodium laurate to the category is justified due to the fact, that sodium laurate is the sodium salt of the corresponding fatty acid lauric acid (CAS 143 -07 -7), a member of the category.
The 14 d toxicity test with docosanoic acid provided by the Ministry of the Environment, Government of Japan (1998) was conducted according to OECD 204 and in accordance with GLP requirements. Medaka (Oryzias latipes) were exposed to docosanoic acid under flow-through conditions in a limit test. The NOEC (14 d) was determined to be 4.99 mg/L based on nominal concentrations. Thus no effects could be observed within the range of water solubility, which is determined to be 0.016 mg/L. Since an exposure time of 14 d is too short regarding current regulations, a further study on chronic fish toxicity is taken into account. The study with sodium laurate is summarized by Egmond et al. (1999) and was conducted according to OECD 305 E (bioaccumulation: flow-through fish test). For an exposure period of 28 days NOEC values were determined based on growth rate and mortality and were 6.4 mg/L and 2 mg/L, respectively. In addition an LC50 (28 d) of 9.8 mg/L based on mortality is reported. All values were given as nominal values, since the measured values were in the range of 100 - 115% of nominal concentrations.
Since the water solubility of fatty acids, dehydrated castor-oil is low (< 0.15 mg/L) it can be concluded, that for fatty acids, dehydrated castor-oil no effects are to be expected up to the limit of water solubility and due to animal welfare further chronic tests with fish are thus considered not appropriate.
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