Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)

Endpoint summary

Additional information

No experimental data on toxicity to fish, aquatic invertebrates and algae are available for C1618FA-TEPA-compound. Toxicity to microorganisms is assessed by a ready biodegradation test with C1618FA-TEPA-compound including a toxicity control. For the assessment of aquatic toxicity a read-across approach to the closely related source substance Partially unsaturated IQAC, DMS quaternised is applied. A justification for read-across is attached to Iuclid section 13.

 

Short-term toxicity to fish

In a 96-h acute toxicity study, Rainbow trouts (Salmo-Gardia, Shasta, Oncorhynchus mykiss) were exposed to the closely related Partially unsaturated IQAC, DMS quaternised. The 96-h LC50 was 9.84 — 10.24 mg/L (nominal, confidence interval: 2.7 - 11.73 mg a.i./L).

 

Long-term toxicity to fish

According to REACH Annex XI, 1.2., long-term testing for toxicity to fish is not necessary as a sufficient weight of evidence from available data. There are three reliable acute tests for aquatic toxicity for three trophic levels (fish, Daphnia, algae) available and, in addition, two long-term tests for two trophic levels (Daphnia and algae). Comparing the effect concentrations for the three trophic levels, fish are not the most sensitive species: fish<algae< invertebrates (see 7.1.2.1).The most sensitive species is daphnia. A long-term fish test is not expected to improve the information on aquatic toxicity or provide lower effect concentrations. The available data are adequate for the purpose of classification and labelling and/or risk assessment as hazardous to the environment (see 7.6). Therefore and for animal welfare reasons, further testing on vertebrate animals for that property shall be omitted.

 

Short-term toxicity to aquatic invertebrates

The 48–hr-acute toxicity of the closely related Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied according to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253μg/L with 95% confidence limits of 146 and 688μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15μg/L based on mean measured concentrations.

In another study, the 24–hr-acute toxicity of the partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied under static conditions.  Daphnids were exposed for 24 hr according to DIN 38 412 Part 11.  Mortality/immobilization was observed.  The 24 – hour EC50 was 0.45 – 0.9 mg a.i../L.  The 24 – hr EC0 based on mortality/immobilization/sublethal was 0.09 mg a.i. /L. The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.

According to REACH Endpoint specific Guidance R.7b, pp 24, 24 hour values can have considerable variability in the repeatability of results. Therefore standard 48 hour values are favoured over 24 hour values. 24 hour values should only be used in the absence of good quality 48 hour values with other available supporting data.

 

Long-term toxicity to aquatic invertebrates

The 21-day-reproduction test of the effluent of a model activated sludge unit fed with 10 mg/L of the closely related substance partially unsaturated IQAC (containing 10% of Isopropanol) to Daphnia magna was studied under static renewal conditions. Daphnidswere exposed to the effluent of the activated sludge unit containing the degradation products of the test item. A control activated sludge unit without the test item was run in parallel. The test duration for every generation was 21 days. Neonates of the 14thtest day were exposed as filial generation under the same conditions as the parental generation. Filial generations 1 and 2 were monitored for reproduction rate, time of the first offspring and parental mortality.

Parental generation: In the parental generation there was no difference between the exposed and the not exposed daphnids, however the first offspring in the controls was one day later. Mortality of the parental generation was slightly higher in the control.

F1 generation:

42 days after the start of exposition of parental generation, the reproduction rate of the surfactant exposed F1 generation was enhanced and exceeded that of the control. The mean number of parental daphnids was greater than in the control. There was no difference in the time of appearance of the first offspring. Mortality of the parental generation was slightly higher in the control.

F2 generation:

63 days after the start of exposition of the first parental generation, in the second filial generation some adverse effects were observed for the surfactant exposed Daphnids: Growth rate decreased and the size and colour of the control animals were not reached. The reproduction rate was significant lower than in the parental generation and the F1 generation. The mortality of the parental animals increased. During the test, partially unsaturated IQAC, DMS quaternised, is eliminated in the model activated sludge unit by > 90%. The elimination is calculated to be 97.75% taking into account the inflow into the model activated sludge unit of the test substance with a concentration of 10 mg/l, the dilution of the effluent of the elimination unit in ratio 1:1.25 and the separately determined EC0=0.1 mg/l to Daphnia magna. Thus a NOEC of >100μg/L is calculated.

The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna is more than 10 000 times lower than the toxicity of the test material.Water solubility of the test item may be slightly enhanced leading to a better bioavailability and slightly enhanced toxicity. But these effects are regarded to have a minor influence on the test result.Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.

 

Toxicity to aquatic algae and cyanobacteria

In a 72 hour toxicity test Pseudokirchneriella subcapitata were exposed to the closely related substance partially unsaturated IQAC, DMS quaternised under static conditions in accordance to OECD Guideline 201 (2006). The 72-hour LOEC for the growth rate was determined to be 1.0 mg/L (corresponding to a mean measured concentration of 21μg/L) and the 72-hour NOEC for the growth rate was determined to be 0.32 mg/L (corresponding to a mean measured concentration of 7.6μg/L) based on water accommodated fractions (WAFs). The 72-hour LOEC for yield was determined to be 0.10 mg/L (corresponding to a mean measured concentration of 2.8μg/L) and the 72- hour NOEC for yield was determined to be 0.032 mg/L (corresponding to a mean measured concentration of 0.52μg/L) based on water accommodated fractions (WAFs).
The measured concentrations in the test media of the two lowest test item treatments with loading rates of 0.010 and 0.032 mg/L were <LOQbio (limit of quantification, 0.614μg/L). The measured concentrations at the loading rates of 0.10, 0.32, 1.0, 3.2, 10 mg/L were 2.2, 6.2, 11, 14 and 22μg/L, respectively. The biological results were related to the loading rates of the test item and to mean measured test item concentrations. There were no compound related phytotoxic effects.

In an acute test with algae according to DIN 38 412 Part 9 a similar result was observed.The EC50 was determined to be EC50 (72 h): ca. 1800 — 4500μg/L act. ingr. (nominal). This value is based on the biomass and therefore not used for the assessment.

In a 5 weeks long-term toxicity study in a Coupled OECD Confirmatory Test the cultures of Scenedesmus subspicatus CHODAT (new name: Desmodesmus subspicatus) were exposed to the degradation products of the closely related partially unsaturated IQAC, DMS quaternised of an activated sludge unit at 24 °C. There was no change in the measured extinction of the algae cultures exposed to the surfactant doted activated sludge unit during the test period of 5 weeks. Only minor variation was observed. The mean extinction was 0.75 E. Visual inspection of the alga cultures showed optimal green coloured cultures, an indication of high active chlorophyll. Sedimentation of algae was not observed. The culture remained stabile over 5 weeks and no negative effects were observed. In comparison the control culture was somewhat labile, so that it could be concluded that the algae culture exposed to the degradation products was slightly promoted. During the test partially unsaturated IQAC, DMS quaternised, is eliminated in the model activated sludge unit by > 90%. The elimination is calculated to be 97.75% taking into account the inflow into the model activated sludge unit of the test substance with a concentration of 10 mg/L, the dilution of the effluent of the elimination unit in ratio 1:1.25 and the separately determined EC0=0.1 mg/L. Thus a NOEC of >100μg/L is calculated.

 

Toxicity to microorganisms

The toxicity of C1618FA-TEPA-compound (ca. 90% a.i.) to microorganisms was investigated during a ready biodegradation study according to EU Method C.4-C (1992) and OECD guideline 301 B (1992), CO2 evolution test over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant. The biodegradation rate was determined by measurement of carbon dioxide evolution. Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and a toxicity control with 27.1 mg/L test item and 25.7 mg/L reference item Sodium benzoate were performed.

The reference item degraded normally (63% by within 14 days). By the end of the test, the reference item was degraded to an average of 72%. At the end of the 28-day exposure period, the mean extent of biodegradation of the test item was 9%. The extent of biodegradation in the toxicity control showed a similar course over the 28-day exposure period when compared to the procedure control containing the reference item, only. Within 14 days of exposure, the extent of biodegradation was 35%. Thus, according to the test guidelines, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 27.1 mg/L, as the biodegradation in the toxicity control was higher than 25% within 14 days of incubation.

 

Conclusion

Results from acute tests with fish, Daphnia and algae are available. Long-term studies are available for Daphnia and Algae. The lowest short-term aquatic toxicity test result is the EC50 (48h) = 3.7 mg/L for Daphnia magna (OECD TG 202) (Acute toxicity test). 

The lowest long-term aquatic toxicity test results are the 63 d NOEC > 100 μg/L for Daphnia magna and the 35 d NOEC > 100μg/L for Desmodesmus subspicatus.