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Ecotoxicological information

Long-term toxicity to fish

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fish early-life stage toxicity
Type of information:
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
Please see the attached QMRF and QPRF reports for applicability of the predicted data
Principles of method if other than guideline:
The ECOSAR ‘neutral organics’ QSARs for chronic data have been applied and the effect concentrations calculated using the octanol-water partition coefficient, log Kow, as the input variable.
GLP compliance:
Predicted data
Test organisms (species):
other: freshwater fish
Water media type:
30 d
Dose descriptor:
Effect conc.:
6 482 mg/L
Conc. based on:
test mat.
Gem Diol form
Basis for effect:
not specified
Remarks on result:
other: predicted NOEC value derived from ChV of 11596 mg/l / 1.789 (reflecting spacing factor of 3.2)
A 30-day NOEC value of 6482 mg/l was obtained for the Gem Diol form of the submission substance using an appropriate calculation method. The results are considered to be reliable.

Description of key information

Freshwater fish 30-day NOEC: 6482 mg/l (predicted value).

Key value for chemical safety assessment

Additional information

No measured long-term toxicity to fish data are available for the registration substance. The data requirement has been fulfilled using QSAR predicted data.

The aqueous form of the registered substance, the Gem Diol, is the relevant species for aquatic assessment, therefore the properties of the Gem Diol have been used as the input parameters for the QSAR.

A 30-day ChV of 11596 mg/l has been determined for the effects of the test substance on freshwater fish using ECOSAR v2.0 for the prediction of the aquatic toxicity of neutral organics. The ChV can be converted to a NOEC value by dividing the ChV by 1.789 (this is a worst case calculation reflecting a spacing factor of 3.2).

The predicted NOEC value for effects of the aqueous form of the registration substance, the Gem Diol, on freshwater fish is therefore 11596/1.789 = 30-day NOEC 6482 mg/l.

Please see the QMRF report attached in the Endpoint Study Record for further details on the prediction method.