Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Toxicity to fish

In 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.

In accordance with REACH Annex IX, 9.1.6, column 2, long-term toxicity testing on fish does not need to be conducted. A test for long-term toxicity on fish is only required if the chemical safety assessment, according to Annex I, indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.As the registration substance does not need to be classified with regard to environmental effects, an exposure assessment is not required. The long-term exposure of aquatic organisms is unlikely as the substance is readily biodegradable. The ready biodegradability of the substance is proved in a number of tests conducted under different conditions (aerobic, anaerobic).

 

Toxicity to aquatic invertebrates

In a study conducted according to EU Method C.2 (Acute Toxicity for Daphnia) the 48h-EC50 of the test substance partially unsaturated TEA-Esterquat for Daphnia magna was determined to be 2.23 mg/l based on estimated concentration (corrected for recovery of 93%).

In accordance with REACH Annex IX, 9.1.5 column 2, long-term toxicity testing on aquatic invertebrates does not need to be conducted. A test for long-term toxicity on aquatic invertebrates is only required if the chemical safety assessment, according to Annex I, indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. As the registration substance does not need to be classified with regard to environmental effects, an exposure assessment is not required. The long-term exposure of aquatic organisms is unlikely as the substance is readily biodegradable. The ready biodegradability of the substance is proven in a number of tests conducted under different conditions (aerobic, anaerobic).

 

Toxicity to algae

For the long-term effect value 72h-ErC10, relevant studies are considered in a Weight of Evidence (WoE) approach: For TEA-EQ (Partially unsaturated, Fully saturated, Oleic acid-based), 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 72h-ErC10 values for these studies are: Cognis (2004) 0.68 mg/L, Evonik (1994f) 1.53 mg/L, Evonik Goldschmidt (2005g) 5.09 mg/L, Kao (1993a) 1.26 mg/L, Kao (1993b) 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 OECD201. 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 72h-ErC10 range from 0.68 – 5.09 mg/L. For the WoE approach, the geometric mean of the five 72h-ErC10 values was calculated. According to this WoE approach, for this endpoint the 72h-ErC10 is 1.48 mg/L.

As acute value 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 (72h-EbC50) value is 2.14 (1.28) mg/L.

 

Toxicity to aquatic microorganisms

For fully saturated TEA-Esterquat the acute bacterial toxicity was determined according to DIN 38412, part 27 (Inhibition of oxygen demand (Sauerstoffzehrungshemmtest). 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.

 

Sediment toxicity

In accordance with column 2 of REACH Regulation, Annex X, section 9.5.1, long-term toxicity testing with sediment organisms does not need to be conducted. Testing shall be proposed if the results of the environmental exposure assessment indicate the need. As the registration substance needs not to be classified, an environmental exposure assessment is not required.