Tall Oil Fatty Acids, compounds with 2-(2-aminoethoxy) ethanol

Endpoint summary

Description of key information

Fish

A key study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203 "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No 440/2008.

 

Due to the low aqueous solubility and complex nature of the test item, the test medium was prepared as a Water Accommodated Fraction (WAF).

 

In accordance with REACH, the test was conducted according to the threshold approach recommended by ECHA. Using this approach, the lowest EL50 value from either the algal growth inhibition study or acute toxicity to Daphnia magna study is set as the threshold loading rate and a "limit test" is conducted at this threshold loading rate. If no mortalities are observed this indicates that fish are not the most sensitive species and that te LL50 is greater than the threshold loading rate. The EL50 value obtained from investigation of acute toxicity to Daphnia magna was the lowest of the two EL50 values and hence the test was conducted at a single loading rate of 1.6 mg/L.

 

Seven fish were exposed to a Water Accommodated Fraction (WAF) of the test item at a single nominal loading rate of 1.6 mg/L for a period of 96 hours at a temperature of 14 °C to 15 °C under semi-static conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination at 96 hours.

 

Analysis of the test preparations at 0 and 72 hours (fresh media) showed that measured concentrations of 1.33 and 1.24 mg/L were obtained respectively.

 

Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.

 

Exposure of rainbow trout to the test item gave LL50 values of greater than 1.6 mg/L loading rate WAF. The No Observed Effect Loading Rate was 1.6 mg/L loading rate WAF.

 

The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) was investigated using the threshold approach and gave a 96 -hour LL50 value of greater than 1.6 mg/L loading rate WAF. The No Observed Effect Loading rate was 1.6 mg/L loading rate WAF.

 

Daphnia magna

A key study was performed to assess the acute toxicity of the test item to Daphnia magna. The method was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.

 

Due to the low aqueous solubility and complex nature of the test item, the test medium was prepared as a Water Accommodated Fraction (WAF).

 

Following preliminary range-finding tests, twenty daphnids (4 replicates of 5 animals) were exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of 0.10, 0.32, 1.0, 3.2 and 10 mg/L for 48 hours at a temperature of 21 to 22 °C under static test conditions. The number of immobilised Daphnia and any adverse reactions to exposure were recorded after 24 and 48 hours.

 

Chemical analysis of the fresh test preparations at 0 hours showed measured test concentrations to range from 1.16 to 9.08 mg/L. Chemical analysis of the aged test preparations at 48 hours showed measured test concentrations to range from 0.742 to 8.54 mg/L.

 

The dissolved test item may have been one or several components of the test item. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on loading rates only.

 

Exposure of Daphnia magna to the test item gave an EL50 (48 h) value of 1.6 mg/L loading rate WAF (95 % confidence limits 1.4 to 2.0 mg/L loading rate WAF). The No Observed Effect loading rate (NOEL) was determined to be 1.0 mg/L and the Lowest Observed Effect (LOEL) was determined to be 3.2 mg/L.

 

Algae

A key study was performed to assess the effect of the test item on the growth of the green alga Pseudokirchneriella subcapitata. The method was designed to be compatible with the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) 761/2009.

 

Due to the low aqueous solubility and complex nature of the test item, a Water Accommodated Fraction (WAF) was prepared.

 

Following preliminary range-finding tests, Pseudokirchneriella subcapitata was exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of 0.10, 0.32, 1.0, 3.2 and 10 mg/L (three replicates per concentration) for 72 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C.

 

Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group using a Coulter multisizer particle counter.

 

Analysis of the test preparations at 0 hours showed measured test concentrations ranged from 0.032 to 7.0 mg/L. A decline in measured test concentrations was observed at 72 hours in the range of less than the Limit of Quantification (LOQ) of the analytical method employed, which was determined to be 0.0024 to 0.012 mg/L.

 

Given that the toxicity cannot be attributed to a single component or a mixture of components but to the test item as a whole, the results were based on nominal loading rates only.

 

Based on growth rate, exposure of Pseudokirchneriella subcapitata to the test item gave an EL50 value of 9.5 mg/L loading rate WAF. The No Observed Effect Loading rate (NOEL) was 1.0 mg/L loading rate WAF and the Lowest Observed Effect Loading rate (LOEL) was 3.2 mg/L based on growth rate. Based on yield, exposure of Pseudokirchneriella subcapitata to the test item gave an EL50 value of 2.6 mg/L loading rate WAF. The No Observed Effect Loading rate (NOEL) was 1.0 mg/L loading rate WAF and the Lowest Observed Effect Loading rate (LOEL) was 3.2 mg/L based on yield.

 

Inhibition of sewage sludge micro-organisms

A key study was performed to assess the effect of the test item on the respiration of activated sewage sludge. The method was designed to be compatible with OECD Guidelines for Testing of Chemicals (2010) No 209 "Activated Sludge, Respiration Inhibition Test (Carbon and Ammonium Oxidation).

 

Following a preliminary range-finding test, activated sewage sludge was exposed to an aqueous dispersion of the test item at concentrations of 100, 180 and 320 mg/L (5 replicates) for a period of 3 hours at temperatures of between 20 to 21°C with the addition of a synthetic sewage as a respiratory substrate.

 

An additional experiment was performed after the definitive test whereby activated sewage sludge was exposed to an aqueous dispersion of 560 mg/L (5 replicates) for a period of 3 hours at temperatures of between 20 to 21°C with the addition of a synthetic sewage as a respiratory substrate in order to determine the No Observed Effect Concentration(NOEC).

 

The rate of respiration was determined after 3 hours contact time and compared to data for the control and reference item, 3 -5 -dichlorophenol.

 

The No Observed Effect Concentration (NOEC) after 3 hours exposure to the test item was 320 mg/L. The reference item gave a 3 -hour EC50 value of 13 mg/L, 95 % confidence limits of 9.7 to 17 mg/L.

Additional information

No additional information.