Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
Justification for type of information:
The water solubility is noted to be below 0.1 mg/l based on work to examine toxicity to Daphnia and algae.
Performing further animal tests cannot be justified.
The substance is classified as toxic on the basis of the work on algae and to perform a fish study at concentrations lower than this is not considered feasible and has no value.
Cross-reference
Reason / purpose:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The data are taken from the analytical monitoring of an acute daphnia study.
Qualifier:
according to
Guideline:
other: OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)
Water solubility:
0.096 mg/L
Temp.:
20 °C
pH:
7.8
Remarks on result:
other: Result of day 1
Water solubility:
0.134 mg/L
Temp.:
20 °C
pH:
7.8
Remarks on result:
other: Result of day 2
Water solubility:
0.115 mg/L
Temp.:
20 °C
pH:
7.8
Remarks on result:
other: Mean value of day 1 and 2
Conclusions:
Interpretation of results: slightly soluble (0.1-100 mg/L)
The solubility in a daphnia medium Elendt M4 is 0.115 mg/L at 20°C. The methodology is different from that of a water-solubility methode, (e.g. OECD 105): The materials (about 10 mg/L) was dissolved by ultrasonication for 1 hour followed by gentle stirring for 24 hours and filtration through a paper filter.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion