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Administrative data

Endpoint:
long-term toxicity to fish
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Although effects were observed in an acute 96 hour fish study, the effect concentration is about 100 times higher than with algae, showing alge to be very much more succeptable to the substance. Further testing on fish cannot be justified as this is not the most sensitive marine or aquatic organism.
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
toxicity to aquatic algae and cyanobacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
72 hours, performed 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Version / remarks:
Including analytical verification
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Purity: 90.8 % Non-volatiles at 130 °C
Physical State/Appearance: Viscous brown liquid
Analytical monitoring:
yes
Details on sampling:
Analysis of the test preparations at 0 hours showed measured test concentrations to range from 0.0012 to 0.37 mg/L. Analysis of the test preparations at 72 hours showed measured test concentrations to range from 0.00074 to 0.29 mg/L.
Given this decline in measured test concentrations it was considered justifiable to base the results on the geometric mean measured test concentrations in order to give a "worst case".
Vehicle:
no
Details on test solutions:
0Nominal concentrations of 0.0010, 0.0032, 0.010, 0.032, 0.10 and 0.32 mg/L
(three replicate flasks per concentration)
Test organisms (species):
other: Raphidocelis subcapitata
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h
Hardness:
Not specified, but stated to be to OECD standard test media
Test temperature:
Temperature was maintained at 24 ±1 ºC throughout the test
pH:
The pH value of the control cultures was observed to increase from pH 7.7 at 0 hours to pH 9.0 at 72 hours.
Nominal and measured concentrations:
Nominal concentrations of 0.0010, 0.0032, 0.010, 0.032, 0.10 and 0.32 mg/L
Mean measured test concentrations 0.00093, 0.0030, 0.010, 0.033, 0.11 and 0.33 mg/L.
Reference substance (positive control):
no
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
ca. 0.071 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Validity criteria fulfilled:
yes
Conclusions:
The substance is considered toxic to the aquatic environment.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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