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short-term toxicity to fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
In accordance with section column 2 of the Annex VIII of the REACH Regulation, the test item has not been tested for toxicity to fish. Indeed, the test item is expected to show a very low solubility and did not exhibit toxic effect to aquatic invertebrates during experimental short-term ecotoxicity study.
These points are elaborated in the two following paragraphs.

1) Elemi resinoid has not been tested for determination of solubility due to identified technical issues. However, TOC measurements were performed during ecotoxicological studies where organisms were exposed to Water Accommodated Fractions of the substance. These measurements give sufficient information to conclude on the low solubility of the substance.
During range-finding tests of short-term studies OECD 201 and OECD 202, two sets of WAF preparations were tested at the following range concentrations: 1, 10, 32 and 100 mg/L of test item. One set of WAFs was prepared by heating and sonication while the other set was prepared using a solvent. TOC analyses were performed during preliminary tests on WAF prepared by heating/sonication for all nominal concentrations, as TOC analysis was not specific enough to separate organic carbon related to the solvent from the one of the test item. Analytical results obtained during the OECD 201 preliminary test showed concentrations of 0.75, 0.91 and 2.16 mg TOC.L-1 in solutions with concentration of 0, 1 and 100 mg test item.L-1, respectively. Analytical results obtained during the OECD 202 preliminary test showed concentrations of 1.08, 1.41 and 2.13 mg TOC.L-1 in solutions with concentration of 0, 1 and 100 mg test item.L-1, respectively.
The low variation in TOC measurements (less than 1.5 mg TOC.L-1) during preliminary tests between control samples and samples with maximum loading rates of 100 mg test item.L-1 indicates that constituents of the test item are poorly solubilized.

2) As described above, acute toxicities of Elemi Resinoid to aquatic invertebrates and to algae were investigated in laboratory studies following OECD guidelines 202 and 201, using WAFs preparations.
For both studies, a preliminary test was performed by exposing organisms to WAFs prepared by sonication/heating or to WAFs prepared with solvent, at the following nominal loading rates od test item : 0, 1, 10, 32, 100 mg/L.
No effect were observed during pre-tests with WAFs without solvent, while using WAFs with solvent, effects were observed to algae only.
Following these results, definitive OECD 201 study was conducted using WAFs prepared with solvent and an EL50 of 77.722 mg test item /L-1 was determined.
The definitive OECD 202 study was conducted with WAFs prepared by heating/sonication in accordance with results obtained during the preliminary test. After 48 hours of exposure, no immobilization of the test animals was observed at the highest nominal test loading rate of 100 mg.L-1. The EC50 was therefore > 100 mg test item.L-1 (loading).

Regarding the mode of action of the substance major constituents (MoA 1), a remarkable difference of magnitude in inter-species toxicities is not expected.
Therefore, due to the vertebrate nature of fishes, it is not considered necessary to perform an OECD 203 study.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion