Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts

Endpoint summary

Description of key information

Due to the low water solubility and complex nature of the test substance, the aquatic ecotoxicity studies with fish, invertebrates and algae were conducted using a WAF (Water Accommodated Fraction) procedure at a maximum loading rate of 100 mg/l. No toxic effects were observed at any of the three trophic levels tested at the maximum loading rate of 100 mg/l WAF. Therefore, it can be concluded that the test substance is not toxic to aquatic organisms at a loading of 100 mg/l WAF and the NOELR (No Observed Effect Loading Rate) is 100 mg/l.

Additional information

With regard to aquatic toxicity several reliable studies on the short-term effects of the test substance (CAS 91744-38-6, Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts) on aquatic organisms are available. Due to the low water solubility of the test substance test samples were prepared as Water Accommodated Fraction (WAF). 

 

In a 96-h acute toxicity study according to OECD 203 and GLP, zebrafish (Danio rerio) exposed to the test substance at the limit concentration of 100 mg/l nominal (WAF, semi-static conditions) did not show mortality. The 96-h LL50 based on mortality is thus > 100 mg/l. No sublethal effects were observed. Therefore it can be concluded that the test substance is not toxic at a loading of 100 mg/l (No Observed Effect Loading Rate, NOELR = 100 mg/l).

 

To assess the acute toxicity of the test substance to Daphnia magna, test animals were exposed to a WAF of the test item at single nominal loading rate of 100 mg/l for 48 hours at a temperature of 21 °C to 22 °C under static test conditions (OECD 202). The 48-Hour EL50 for the test item to Daphnia magna based on nominal loading rates was greater than 100 mg/l loading rate WAF. The NOELR was 100 mg/l loading rate WAF.

 

The 72-h effects of the test substance on the growth of the green alga Pseudokirchneriella subcapitata was investigated in a study according to OECD 201. Pseudokirchneriella subcapitata was exposed to WAFs of the test item over a range of nominal loading rates of 6.25, 12.5, 25, 50 and 100 mg/l (three replicate flasks per concentration) for 72 hours. Resulting EL50 values were greater than 100 mg/l loading rate WAF. The No Observed Effect Loading Rate was 100 mg/l loading rate WAF.

 

The studies referenced above indicate that in the range of water solubility the test item was not toxic to Danio rerio, Daphnia magna and Pseudokirchneriella subcapitata under the respective test conditions.

 

In addition to the above referenced studies, a Respiration Inhibition Test with activated sludge according to OECD 209 was carried out with the test item and activated sludge of a municipal treatment plant at a limit test concentration of 1000 mg/l. The NOEC of the test was determined to be 1000 mg/l. Thus, the test item is considered not toxic at the limit concentration of 1000 mg/l to activated sludge of a municipal sewage treatment plant.

Studies regarding the long-term toxicity to fish and aquatic invertebrates are not available for the test substance. In accordance with REACH Annex IX, 9.1, column 2, long-term toxicity testing shall be proposed if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. As the test substance is readily biodegradable and available data do not indicate any hazard to aquatic organisms due to exposure to the test substance, a study on the long-term toxicity to aquatic invertebrates or fish is not proposed.