Reaction products of alkenyl dihydrofuran-2,5-dione and polyisoalkenyl dihydro-2,5-furandione with alkylene glycol

Endpoint summary

Description of key information

Fish

The key study was performed on the reference substance. The 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, for the purposes of the test, the test medium was prepared as a water accommodated fraction (WAF)

Following a preliminary range-finding test, seven fish were exposed to aWAF of the test item, at a single nominal concentration of 100 mg/L loading rate WAF for a period of 96 hours at a temperature of approximately 14 °C under semi-static test 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 after 96 hours.

Chemical analysis of the 100 mg/L loading rate WAF test preparations at 0 and 24 hours showed that measured concentrations of 0.0037 and 0.0031 mg/L were obtained respectively indicating that the test item was stable under test conditions. Due to inconsistencies during validation, the method was amended prior to the definitive test, therefore the range finding samples were analysed using a different method to that of the definitive test, which had a slightly higher LOQ.

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

Exposure of rainbow trout (Oncorhynchus mykiss) to the test item gave a LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.

Daphnia

The key study was performed on the reference substance.

A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to becompatible 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, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF)

Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals) were exposed to a WAF of the test item at a single nominal loading rate of 100 mg/L for 48 hours at a temperature of approximately 21 °C under static test conditions. The numbers of immobilized Daphnia and any adverse reactions were recorded after 24 and 48 hours.

Chemical analysis of the 100 mg/L loading rate at 0 and 48 hours showed measured test concentrations of 0.62 and 0.49 mg/L respectively. The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only.

Exposure of Daphnia magna to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.

It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L.

Algae

The key study was performed on the read-across substance Ethylene glycol, reaction products with polyisobutenyl succinic anhydride and hexadecenyl succinic anhydride, salts with dimethylethanolamine. The justification for read-across is attached in Section 13 of the IUCLID.

A study was performed to assess the effect of the test material on the growth of the green alga Selenastrum capricornutum. The method followed that described in the OECD Guidelines for Testing of Chemicals (1984) No 201, “Alga, Growth Inhibition Test” referenced as Method C.3 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and US Code of Federal Regulations, Title 40, Part 797, Section 1050.

Following a preliminary range-finding study, Selenaastrum capricornutum was exposed to an aqueous dispersion of the test material at a concentration of 100 mg/L (six replicate flasks) for 96 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.

The effect of the test material on the growth of Selenastrum capricornutum gave EC50 values > 100 mg/L. Correspondingly the No Observed Effect Concentration (NOEC) was greater than or equal to 100 mg/L.

It was considered unecessary and unrealistic to test at concentrations in excess of 100 mg/L.

Analysis of test solutions at 0 and 96 hours showed a marked decline in test concentrations and so it was considered justifiable to base the results on the measured test concentrations also. Based on mean measured test concentrations, the EC50 values were greater than 63 mg/L and the NOEC was greater than or equal to 63 mg/L.

Micro-organisms

The key study was performed on the read-across substance Ethylene glycol, reaction products with polyisobutenyl succinic anhydride and hexadecenyl succinic anhydride, salts with dimethylethanolamine. The justification for read-across is attached in Section 13 of the IUCLID.

A study was performed to assess the effect of the test item on the respiration of activated sewage sludge. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1984) No 209 "Activated Sludge, Respiration Inhibition Test" and EC Commission Directive 87/302/EEC.

The test material was aeratedfor a period of 3 hours at a temperature of 21°C in the presence of activated sludge with synthetic sewage as a respiratory substrate. The rate of respiration was determined after 30 minutes and 3 hours contact time and compared to data for the control and a reference item, 3,5-dichlorophenol.

The effect of the test item on the respiration of activated sewage sludge gave a 3‑Hour EC₅₀value of 390 mg/L.

The reference item gave a 3-Hour EC₅₀value of 7.0 mg/L.