Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The NOEC obtained from the earthworm reproduction study was 1000 mg/kg dw.

 

The overall NOEC obtained from the seedling emergence and growth study was 250 mg/kg dw.

 

The NOEC obtained from the study was <62.5 mg/kg dw, the lowest concentration tested.

Additional information

In the chemical safety assessment performed according to Article 14(3) in connection with Annex I section 3 (Environmental Hazard Assessment) no hazard was identified. Therefore according to REACH Annex I (5.0) exposure estimation is not necessary. Consequently, in accordance with Column 2 of REACH Annex X, the study does not need to be conducted as all identified uses of the substance are assessed as safe for the environment.

Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised C14 -22, 2 -ethylhexylesters is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.

See read across justification report in section 13

Terrestrial toxicity tests have been performed on ESBO and are provided as read-across in sections 6.3.1, 6.3.3, 6.3.4

These ESBO tests are summarised below

The toxicity of Soybeanoil, epoxidized to the earthworm species Eisenia fetida was determined in a static 8 week test according to OECD Guideline 222 (2004). Nominal exposure concentrations were 62.5, 125, 250, 500 and 1000 mg Soybeanoil, epoxidized/kg soil dry weight. Each test concentration was replicated 4 times with 8 control replicates, each replicate contained ten earthworms. After 28 days of exposure in soil, no earthworm mortalities, no significant pathological symptoms or changes in the behaviour of adult earthworms were observed in any of the treatment concentrations. Moreover, no statistically significant differences in earthworm body weights were observed in any treatment compared to the control. After a further four weeks, the reproduction rate (average number of juveniles produced) was 37 in the control and was 39, 42, 53, 44 and 54 in the 62.5, 125, 250, 500 and 1000 mg/kg dry weight soil treatment rates. Compared to the control, no statistically significant reduction of reproduction was observed in any of the soybeanoil, epoxidized concentrations. The mortality, biomass and reproduction NOECs of soybeanoil, epoxidised concerning were determined to be 1000 mg/kg soil dry weight. The EC50 values for biomass and reproduction were not determined since no significant effects ≥ 50 % occurred. All validity criteria recommended by the test guideline were fulfilled.

The toxic effects of Soybeanoil, epoxidized to Avena sativa (oats), Allium sepa (onion), Beta vulgaris (sugar beet), Brassica napus (rape), Daucus carota (carrot) and Glycine max (soybean) was determined in seedling emergence and seedling growth tests over a period of 21 days (for onion and carrot exposure was over 28 days), according to OECD 208 (July 2006). Test systems comprised of two monocotyledons, oats (Poaceae) and onion (Liliaceae), and four dicotyledons, sugar beet (Amaranthaceae), rape (Brassicaceae), carrot (Umbelliferae) and soybean (Leguminosae). The test was conducted with the nominal test concentrations of 62.5, 125, 250, 500 and 1000 mg/kg dw (soil dry weight). The NOEC values, as well as the calculated EC-values were calculated for seedling emergence, shoot weight and shoot height. The seedling emergence EC50 for all plant species was >1000mg/kg dw, and the corresponding NOECs were all 1000 mg/kg dw. The shoot height EC50 for all six plant species was >1000mg/kg dw and the corresponding NOECs were 500 mg/kg dw soil for onion, sugar beet and rape and 1000 mg/kg dw soil for oats, carrot and soybean.   The shoot weight EC50 value for all six plant species except rape was>1000mg/kg dw, except for rape which was 909 mg/kg dw. The corresponding NOECs were 250 mg/kg dw for rape, 500 mg/kg dw for otas, onion, sugar beet and carrot and 1000 mg/kg dw for soybean. At test end slight test item related effects occurred for the plant species sugar beet at the test concentration 1000 mg/kg dw. For the plant species oats, onion, rape, carrot and soybean no test item related phytotoxic effects were determined up to the highest tested concentration of 1000 mg/kg dw. The results of the control for all plant species met the required validity criteria.

The effects of Soybeanoil, epoxidized on the metabolic activity of the nitrogen-N formation rate (nitrate) soil micro-organisms was determined according to OECD Guideline 216 (2000) over a 28 day period. Nominal test concentrations were 62.5, 125, 250, 500 and 1000 mg/kg soil dry weight. The effects of Soybeanoil, epoxidized on the metabolic activity of the nitrogen-N formation rate (nitrate) was measured on the day of treatment (day 0) and after 7, 14 and 28 days. Untreated soil was tested as the control under the same test conditions as the test item replicates. After 7 days of exposure the EC25-value for inhibition of the nitrate-N formation rate in soil was under the lowest test item concentration of 62.5 mg/kg soil dry weight. The EC50-value was determined to be 76.6 mg/kg soil dry weight with a corresponding NOEC of <62.5 mg/kg dw. After 14 days of exposure the EC25- and EC50-values for inhibition of the nitrate-N formation rate were 109 and 169 mg/kg soil dry weight, respectively with a corresponding NOEC of 62.5 mg/kg dw. After 28 days of exposure the EC25-value for inhibition of the nitrate-N formation rate in soil was 182 mg/kg soil dry weight. The 28 day EC50-value was 402 mg/kg soil dry weight with corresponding LOEC and NOECs of 62.5 and <62.5 mg/kg dw soil respectively. Test validity criteria were fulfilled