Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
This information was requested based on ECHA decision number CCH-D-2114453719-37-01/F, but due to notified reduced tonnage to Annex VIII, this endpoint is not required. However, this dossier has not been possible to submit at Annex VIII do to business rules and restrictions within the REACH IT system. Requests have been made to rectify the tonnage reduction notification.
Other Joint Registrants are not relying on Annex IX data.
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