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Ecotoxicological information

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Description of key information

Overall, the most sensitive organism in all available studies was fish. Thus, the lowest NOEC/EC10 was 0.224 mg/L obtained in the FELS test conducted with Danio rerio.

Additional information

A short-term toxicity study in fish is available for the target substance oleic acid-based TEA-Esterquat A full set of short- and long-term aquatic toxicity studies is available for the source substance partially unsaturated TEA-Esterquat. A justification for read-across is attached to Iuclid section 13.


 


Short-term toxicity to fish


The most critical value was obtained in a study with the source substance partially unsaturated TEA-Esterquat: Iin a 96-h acute toxicity study conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test), rainbow trouts (Oncorhynchus mykiss) were exposed to partially unsaturated TEA-Esterquat at nominal concentrations of 0 (control), 1.0, 1.6, 2.56, 4.1, 6.55, 10.55 mg/l under semi static conditions. The mean measured concentrations were determined to be 59 % of nominal concentrations. The 96-h LC50 was 1.91 mg/L (based on mean measured concentrations). Sublethal effects such as difficulties with maintenance of balance and unusual behaviour (reduced activity and or orientation to bottom or surface of the test vessels) were observed within the first three hours in the highest test concentration.


 


Long-term toxicity to fish 


The effects of the test item partially unsatd TEA-Esterquat on the early-life stage of fish (Danio rerio/ Zebrafish) were determined according to OECD Guideline 210.


A test item dispersion with a dry content of 10.3% was prepared from the original test item. Stock dispersions in demineralized water with nominal concentrations of 8.00, 16.0, 32.0, 64.0 and 128 g dispersion/L, corresponding to 0.824, 1.65, 3.30, 6.59 and 13.2 g test item/L were prepared in appropriate intervals of 3 to 4 days and continuously dosed to the dilution water in a flow-through system. Based on the results of a range finding test the test was conducted as a dose-response test with the nominal test item loading rates of 4.00, 8.00, 16.0, 32.0 and 64.0 mg dispersion/L, corresponding to 0.412, 0.824, 1.65, 3.30 and 6.59 mg test item/L), corresponding to time weighted arithmetic mean measured concentrations of 0.224, 0.461, 0.982, 2.60 and 4.68 mg test item/L..


The test was started by placing fertilized eggs into the test vessels and it lasted 34 days (30 days post-hatch). 80 eggs of Danio rerio/ zebrafish were exposed to each test item loading rate and the control (4 replicates with 20 eggs each).


The water quality parameters pH-value, oxygen concentration, temperature and total hardness were within the acceptable limits.


On study day 4, 95% of the control larvae had hatched. Therefore, study day 4 was defined as post hatch day 0 (= PHD 0).


Different toxicological endpoints were determined: hatching success, fry growth (assessed via length and fresh weight measurements on PHD 30), morphological and behavioral effects, post-hatch survival and overall survival.


Specific analysis of various concentrations of the test item in the test media and the controls was carried out via LC-MS/MS.


The test media were sampled and analyzed from alternating test vessels prior to exposure on day -1 and during the exposure on study days 0, 7, 14, 21 and 28.


The measured concentrations of the test media during equilibration days -3 to -1 ranged between 70 and 109% of the nominal loading rates. The measured concentrations of the test media on study days 0 to 28 were in the range of 31 to 88% of the nominal loading rates.


The stock dispersions were sampled and analyzed from freshly prepared and corresponding 4 days aged stock dispersions. Measured concentrations of the freshly prepared stock dispersions were 92 to 99% of the nominal values. Measured concentrations of the 4 days aged stock dispersions in the range of 91 to 99% of the nominal values.


 


At the end of the exposure on study day 34 the aqueous phase of replicates used for analysis of glassware adsorption were analysed too. The sorption of the test item on glass was quantified at the loading rates of 4.00 and 16.0 mg dispersion/L from one replicate per test group at the end of the exposure and from one replicate the loading rate of 64 mg dispersion/L after 100 % mortality occurred.


 


Findings and Observations


The results of the parameters hatching success, fry growth (expressed as weight and length measurement at PHD 30), post-hatch survival and overall survival were checked for statistically significant differences.


Partially unsaturated TEA-Esterquat caused significant effects on Zebrafish in an early life stage test, 30 days post hatch when tested with nominal loading rates of 0.412, 0.824, 1.65, 3.30 and 6.59 mg test item/L, corresponding to the time weighted arithmetic mean measured (TWA) concentrations of 0.224, 0.461, 0.982, 2.60 and 4.68 mg test item/L.


For the parameter hatch, the NOEL was 0.824 mg test item/L nominal (TWA: 0.461 mg test item/L). For the parameters post hatch survival and overall survival, the NOELs were 0.412 mg test item/L nominal (TWA: 0.224 mg test item/L), respectively. For the parameter fry growth (expressed as length and fresh weight) the NOELs were 0.824 mg test item/L nominal (TWA: 0.461 mg test item/L) for both parameters.


 


Short-term toxicity to aquatic invertebrates


The 48 hr acute toxicity of partially unsaturated TEA-Esterquat to Daphnia magna according to EU Method C.2 (Acute Toxicity for Daphnia) was studied under static conditions.  Daphnids were exposed to control, and partially unsaturated TEA-Esterquat at nominal concentration of 1, 2.2, 4.84, 10.6, 23.4, 51.5, 113 mg test mat./L for 48 hr.  Mortality/immobilization was observed daily. The 48 hour EC50 was 2.23 mg a.i./L. The effect concentration was corrected for the analytical recovery of 93%


 


Long-term toxicity to aquatic invertebrates


A Daphnia magna reproduction test (semi-static, 21 d) of partially unsaturated TEA-Esterquat was conducted at the test facility according to OECD 211 (2012). The test species was Daphnia magna STRAUS. Ten daphnids, held individually, were used per concentration level and control. At test start the daphnids were < 24 hours old. The study was carried out under semi-static conditions with a daily renewal. The aim of the test was to assess the effects on the reproduction capacity and other test item-related effects or parameters such as the intrinsic rate of the natural increase, first appearance of living juveniles, occurrence of aborted eggs and stillborn juveniles, adult mortality, body length and dry weight of the parental daphnids.


Nominal concentrations of the test item were selected based on the results of a preliminary range finding test (non-GLP) as follows: 2.00 - 6.32 - 20.0 - 63.2 - 200 mg dispersion/L (separation factor √10), corresponding to 0.208 – 0.658 – 2.08 – 6.58 – 20.8 mg test item/L (dry content of the suspension: 10.4%) and the time weighted mean measured concentrations 0.0935 - 0.268 - 0.984 - 2.41 - 9.29 mg test item/L.


A stock solution with a nominal concentration of 200 mg dispersion/L was prepared as specified in section 5.2 and was used for the preparation of the concentration levels in the range of 2.00 - 200 mg dispersion/L in a geometric series with a separation factor of √10 by dilution with dilution water.


The test item concentrations were analytically verified via LC-MS/MS in the fresh media at the start of the exposure-renewal intervals on days 0, 7, 14, 16 (0 hours) and in the old media at the end of the exposure intervals on days 1, 8, 15, 17 (24 hours, respectively) in all concentration levels and in the control.


The measured concentrations of the test item in fresh media at the start of the respective exposure-renewal intervals (0 hours) were in the range of 78 to 98% of the nominal concentrations. At the end of the respective exposure-renewal intervals (48 and 72 hours), the measured test item concentrations in the old media were in the range of <LOQ to 29% of the nominal concentrations.


Since the measured test item concentrations were not within ± 20% of the nominal concentrations, the time weighted mean measured test item concentrations were used for the evaluation of the effect-concentrations.


The environmental conditions were within the acceptable limits. The validity criteria of the test guideline were met. To be valid, the maximum control mortality rate of parent animals must not exceed 20% and the mean offspring number of the survived females at day 21 must be at least 60.0. In the present test, the mortality was 20% and the mean offspring number of the survived females was 95.6 in the control.


The overall effect threshold for effects of the test item under the test conditions was 0.268 mg/L (NOEC) and 0.984 mg/L (LOEC) based on the time weighted mean measured concentrations of the test item. The EC10 for reproduction was determined to be 0.346 mg/L based on the time weighted mean measured concentrations of the test item.


 


Toxicity to algae


Acute value 72 h ErC50:


The lowest effect concentration of all valid tests is used. The test was made with fully saturated TEA-Esterquat which inhibited significantly the increase of biomass of the alga Scenedesmus subspicatus in a study conducted according to OECD Guideline 201 (Alga, Growth Inhibition Test). The 72h-ErC50 was 1.52 mg/L.


 


Long-term value 72 h EC10:


As long-term effect value, instead of the NOEC, the EC10 is used. The current OECD guideline 201 as well as ECHA Guidance R.10, 2008 (Table R.10-1) as well as ECHA CLP Guidance, Nov. 2012 (4.1.3.1.1) recommend the use of the ErC10 instead of NOEC for classification as well as starting point for PNEC derivation.


For the long-term effect value 72 h ErC10, relevant studies are considered in a Weight of Evidence (WoE) approach: For the endpoint “Toxicity to aquatic algae and cyanobacteria”, there are five valid and comparable studies for the same taxonomic group available. For each study there is a full endpoint study record (EPR) in the dossier.


The 72 h ErC10 values for these studies are:


(a): 0.68 mg/L


(b): 1.53 mg/L


(c): 5.09 mg/L


(d): 1.26 mg/L


(e): 1.26 mg/L


The assessment of these comparable studies showed no study inherent reason for differences in results. All five studies were conducted following guidance OECD Guideline 201. All five EPR consider for effect calculation a concentration reduction factor to map the decrease of nominal concentration during the test duration. The values for the 72 h ErC10 range from 0.68 - 5.09 mg/L. For the WoE approach, the geometric mean of the five 72 h ErC10 values was calculated. According to this WoE approach, for this endpoint the 72 h ErC10 = 1.48 mg/L.


 


Toxicity to aquatic microorganisms


In a study with fully saturated TEA-Esterquat the acute bacterial toxicity towards Pseudomonas putida was determined under static conditions according to DIN 38412, part 27 (Inhibition of oxygen demand (Sauerstoffzehrungshemmtest) at test material concentrations of 10, 30, 100 mg test mat./L. The calculated effect concentrations after 30 minutes were as follows: EC0: 24.0 mg a.i./L, EC10: 29.6 mg a.i./L, EC50: 60 mg a.i./L.


Supporting data are available for partially unsaturated TEA-Esterquat, which are described in section “Toxicity to microorganisms”.


 


Conclusion 


Overall, the most sensitive organism in all available studies was fish. Thus, the lowest NOEC was 0.224 mg/L obtained in the FELS test conducted with Danio rerio.