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For the assessment of aquatic toxicity of MDIPA-Esterquat C16-18 and C18 unsatd., short-term toxicity data with fish, aquatic invertebrates and algae are available. Long-term toxicity to fish and aquatic invertebrates as well as toxicity to microorganisms is assessed by read-across to the closely related MDEA-Esterquat C16-18 and C18 unsatd.. A justification for read-across is attached to iuclid section 13.


 


Short-term toxicity to fish


The 96–hr-acute toxicity of the target substance MDIPA-Esterquat C16-18 and C18 unsatd. to eggs of Danio rerio was studied under semi-static conditions according to guideline OECD guideline 236 (2013). Eggs were exposed to control and test chemical at analytically determined geometric mean concentrations of 0, 0.986, 1.90, 4.15, 8.05, and 16.0 mg/L under semi-static conditions with daily renewal. Analytics and all observations were made daily.


The 96-hour LC50 was estimated to be 11.7 mg/L with 95% confidence limits of 9.91 and 13.8 mg/L.


 


Similar results were obtained with the closely related read-across substance MDEA-Esterquat C16-18 and C18 unsatd.:


In a 96 h acute toxicity study according to OECD TG 203, the Zebrafish (Danio rerio), was exposed to MDEA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0, 1.0, 1.6, 2.5, 4.0, 6.3 and 10 mg/L under static conditions. The nominal 96 h LC50 value based on mortality was 5.2 mg/L (95% C.I.: 4.4 to 6.3 mg/L).


 


Long-term toxicity to fish


The 35-day chronic toxicity of the source substance MDEA-Esterquat C16-18 and C18 unsatd. to early life stages of Fathead minnow, Pimephales promelas, was studied under flow-through conditions according to US EPA TSCA, 40 CFR, Part 797.1600. Fertililised eggs (25 eggs, reduced to 15 fry after hatch) were exposed to a control and measured concentrations of 0.686, 1.41, 2.68, 5.30 and 9.76 mg/L as total activity by LSC. The test system was maintained at 25 +/- 1°C and a pH of 8.0 (7.7 to 8.3). The 35-day NOEC values, based on mortality (post-fry reduction) and sub-lethal effects (length and weight) were 0.686 mg/L. The 5-day NOEC based on number hatched was >9.76 mg/L. Although the post-fry reduction survival did not monotonically decrease with exposure concentration, a NOEC of 0.686 mg/L could statistically be determined.


 


Short-term toxicity to aquatic invertebrates


The 48–hr-acute toxicity of the target substance MDIPA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was studied under semi-static conditions.  Daphnids (<24 h) were exposed to control and test chemical at analytically confirmed nominal concentrations of 0, 2.5, 4.5, 8.1, 14 and 25 mg/L in the presence of 4 mg/L (< 2mg/L DOC) humic acid for 48 h.  Immobilisation was observed daily. 


The 48-hour EC50 was 6.7 mg/L (analytically confirmed nominal concentration) based on immobilisation.  


 


Similar results were obtained with the closely related read-across substance MDEA-Esterquat C16-18 and C18 unsatd.: 


The 24-hr acute toxicity of MDEA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was investigated under static conditions in a study conducted according to OECD TG 202 (Part I). Daphnids were exposed to 0, 0.1, 0.32, 1.0, 3.2, 10 and 32 mg/L (nominal) for 24 hours. Immobilisation was observed at test termination. The 24-h EC50 was 14.8 mg/L with 95% CL of 8.4 - 26.2 mg/L(nominal each). No other effects were noted. The study period of 24 h was recommended before adoption of the OECD Guideline 202 in 2004. Therefore this study does not meet this criterium (study duration 24 h instead of 48 h) of today’s standard test methods.


 


Long-term toxicity to aquatic invertebrates


The 21-day chronic toxicity of MDEA-Esterquat C16-18 and C18 unsatd. to Daphnia magna was investigated under flow-through conditions in a study conducted according to EPA OTS 797.1330 (Daphnid Chronic Toxicity Test). Daphnids were exposed to a control and test chemical at measured concentrations of 0, 0.27, 0.47, 1.0, 2.0 and 3.9 mg/L. The 21-day EC50 based on mortality was 1.7 mg/L (95% confidence limits of 1.5 and 1.9 mg/L). The 21 -day NOEC based on survival, number of young/adult/reproduction day, and growth (length and weight) was 1.0 mg/L. Production of offsprings in the treated groups indicated that MDEA-Esterquat C16-18 and C18 unsatd. has an effect on the reproduction at concentration greater than 1 mg/L.


 


Toxicity to aquatic algae and cyanobacteria


In a 72 hour acute toxicity study, the cultures of Pseudokirchneriella subcapitata, strain: NIVA CHL 1 were exposed to MDIPA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0 (control), 0.25, 0.80, 2.5, 8.0 and 25 mg/L, corresponding to measured (TWA) 0.29, 0.91, 2.7, 6.2 and 25 mg/L in the presence of 4 mg/L humic acid (DOC < 2 mg/L) under static conditions in accordance with OECD guideline 201 (adopted March 23, 2006; Annex 5 corrected 28 July 2011).


Microscopic observations revealed no abnormalities.


The NOEC, EC10 and EC50 based on growth rate were 2.7, 3.2 (95% c.i. 2.5-4.1 mg/L) and 8.1 mg/L (95% c.i. 6.4-10 mg/L), respectively.


The NOEC, EC10 and EC50 based on based on yield were 0.91, 1.3 (95% c.i. 0.45-3.7 mg/L) and 4.4 mg/L (95% c.i. 1.6-12 mg/L), respectively. All effect levels are given based on measured (TWA) concentrations.


 


Similar results were obtained with the closely related read-across substance MDEA-Esterquat C16-18 and C18 unsatd.:


Data are available from a substance with the same structure as MDEA-Esterquat C16-18 and C18 unsatd., only the distribution of fatty acid moiety is shifted to a higher amount of unsaturated C18' (Iodine value 47 instead of 25). From a higher amount of unsaturated C18 a higher toxicity is to be expected. In this 72 -h algal study conducted according to OECD TG 201, Scenedsmus subspicatus (new name Desmodesmus subspicatus) were exposed to the similar substance ethanaminium, 2-hydroxy-N-(-2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18 unsatd. fatty acids, chlorides (Iodine value of 47 instead of 25, the highest value for the submitted substance) at measured concentrations of 0, 1.5, 2.8, 6.6, 16, 29 and 64 mg/L under static conditions. The 72 -h EC50 based on biomass is 3.2 mg/L with 95% confidence limits of 2.7 - 3.6 and the 72 -h EC50 based on growth rate is 6.3 mg/L with 95% confidence limits of <1.5 - >64. The 72 -hr NOEC based on growth rate and biomass is 1.5 mg/L (measured concentrations each).


In a 96 h algal toxicity study conducted according to a modification of EPA OTS 797.1050 (Algal Toxicity, Tiers I and II), Selenastrum capricornutum was exposed to MDEA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0, 2, 4, 8, 16 and 32 mg/L under static conditions. The 96 hr ErC50 value was 2.9 mg/L (95% confidence limit <2.0 - 4.2 mg/L; nominal).


This toxicity study is classified as not reliable and does not satisfy the guideline requirements for aquatic toxicity to algae (validity Klimisch 3). Deviations were: no analytical determination of the test substance, river water was used instead of algal media, and cell counts were conducted on controls at the 0 h timepoint only.


 


Toxicity to microorganisms


The influence of MDIPA- Esterquat C16-18 and C18 unsatd. on the degradation of the reference substance sodium benzoate was tested according to OECD guideline 301B. With 20 mg DOC/L resp. 28.2 mg a.i./L test substance and 20 mg/L reference substance the degradation was 61%after 14 days and 91% after 28 compared to 100% degradation with the reference substance alone. From this it can be concluded, that the 28d-IC10 is above 28.2 mg/L and the 14 d-IC50 is above 28.2 mg/L.


Besides the experimental data available for the target substance MDIPA Esterquat C16- 18 and C18 unsatd. an Activated Sludge Respiration Inhibition Test is available for the source substance MDEA-Esterquat C16-18 and C18 unsatd.


In a 3-hour toxicity study, activated sludge fed with synthetic sewage was exposed to MDEA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0 and 47.4 mg a.i./L in accordance with OECD 209 (Activated Sludge Respiration Inhibition). The NOEC based on respiration rate was >47.4 mg a.i./L.


 


Conclusion


Adequate and reliable scientific information indicates that the source substance MDEA-Esterquat C16-18 and C18 unsatd.and the target substance MDIPA-Esterquat C16-18 and C18 unsatd. have similar ecotoxicity profiles. Short-term toxicity data obtained in fish, daphnia and toxicity data from algae are comparable. Both substances are readily biodegradable and show a similar adsorption/desorption behaviour.


The structural similarities between the source and the target substance and the expected similarities of their breakdown products as presented above further support the read-across hypothesis.


Therefore, based on the available data, it can be concluded that the results of the long-term toxicity studies in fish and daphnia, as well as the results from the Activated sludge respiration inhibition test with the source substance are likely to predict the properties of the target substance and are considered as being adequate to fulfil the information requirement of Annex IX, 9.1.5, 9.1.6 and Annex VII, 9.1.4.