Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study planned
Study period:
2013-2014
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. It is the case for Vegeflux Soy, as no effect were observed in the three acute toxicity test up to the solubility limit (freshwater: fish, daphnia and algae): LL0 > 100 mg/L. A temporary PNEC at 0.1 mg/L was calculated. However as no effects are observed in short-term tests, it is not be possible to undertake a full quantitative risk assessment using a PECwater/PNECwater In order to reevaluate and refine the PNECwater, it is proposed to conduct a long-term test in Daphnia magna (and not in fish,as the sensitivity seems equivalent).

Data source

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Qualifier:
according to
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Principles of method if other than guideline:
Due to the low water solubility of the test item, a saturated solution will be prepared (WAF method).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion