Registration Dossier

Administrative data

Endpoint:
sediment toxicity: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 June 2019 - 06 December 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 225 (Sediment-Water Lumbriculus Toxicity Test Using Spiked Sediment)
Version / remarks:
Details are specified in the report
Deviations:
no
Principles of method if other than guideline:
equivalent to guideline
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) and Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) methyl esters
EC Number:
939-235-7
Molecular formula:
Please refer to 'remarks'
IUPAC Name:
Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) and Fatty acids, C16-C18 (even numbered) and C18 (unsaturated) methyl esters
Test material form:
other: liquid
Specific details on test material used for the study:
Typical process material, produced under typical technical conditions

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Average sampling

Test substrate

Vehicle:
no
Details on sediment and application:
Reconstituted water according to OECD guideline No. 203
(OECD 1992); spiked artificial sediment according to OECD
guideline No. 225 (OECD 2007); addition of feed to sediment
before application of test item; no additional feeding

Test organisms

Test organisms (species):
Lumbriculus variegatus
Details on test organisms:
Lumbriculus variegatus (Müller), synchronised adult worms of similar size

Study design

Study type:
laboratory study
Test type:
static
Water media type:
freshwater
Type of sediment:
artificial sediment
Limit test:
no
Exposure duration
Duration:
28 d
Exposure phase:
total exposure duration

Test conditions

Test temperature:
20.9–21.5 °C (n=35; manual measurement in the test vessels);
20.0–21.8 °C (n=671; automatic measurement; 1-h intervals in a separate vessel)
pH:
7.7–8.4
Dissolved oxygen:
≥83% (ASV)
Ammonia:
0 - 9.17 mg/L NH4+.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
ca. 500 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 500 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
ca. 500 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Key result
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 500 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
biomass
Details on results:
After 28 days of exposure, no mortality was observed up to the highest concentration level. In all replicates 10 or more worms were found. Therefore, the parameter survival was not affected up to the highest test item concentration level and no statistical evaluation was performed on worm survival. Additionally the impact of the test substance to biomass and reproduction is visible, but very low.
Reported statistics and error estimates:
please refer to the report

Applicant's summary and conclusion

Validity criteria fulfilled:
yes