Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Sediment toxicity

Currently viewing:

Administrative data

Endpoint:
sediment toxicity: long-term
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 218 (Sediment-Water Chironomid Toxicity Test Using Spiked Sediment)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Cas Number:
167173-85-5
Molecular formula:
C26H30N2O9
IUPAC Name:
(3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Specific details on test material used for the study:
Substance name: X642188
Lot #: SYN-FS08353-048 (TSN303567)
Purity: 99%

Sampling and analysis

Analytical monitoring:
yes

Test substrate

Vehicle:
yes
Remarks:
acetone

Test organisms

Test organisms (species):
Chironomus riparius

Study design

Study type:
laboratory study
Test type:
static
Water media type:
freshwater
Type of sediment:
artificial sediment
Remarks:
formulated sediment constituents: 75% fine industrial sand (more than 50% of the particles 50-200 μm), 20% kaolin clay (kaolinite content > 30%), and 4-5% sphagnum peat (particle size ≤ 1 mm).
Exposure duration
Duration:
28 d
Exposure phase:
total exposure duration

Test conditions

Hardness:
152 to 270 mg CaCO3/L
Test temperature:
20.1 to 21.2 ºC
pH:
8.0 to 8.5
Dissolved oxygen:
7.6 to 8.8 mg/L (90 to 101% saturation)
Ammonia:
Un-ionized Ammonia: 0.00 mg/L
Nominal and measured concentrations:
Nominal Sediment Concentrations: 0 (control), 0 (vehicle control), 0.63, 1.3, 2.5, 5.0, and 10 mg/kg
Day 0 Mean Sediment Concentrations: Time-Weighted Mean Sediment Concentrations:
Reference substance (positive control):
yes
Remarks:
Potassium chloride (assessed in a different study)

Results and discussion

Effect concentrationsopen allclose all
Duration:
10 d
Dose descriptor:
EC50
Effect conc.:
> 2.8 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
other: Survival
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
>8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
Duration:
28 d
Dose descriptor:
EC50
Effect conc.:
> 2.8 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
emergence rate
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
>8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
Key result
Duration:
10 d
Dose descriptor:
NOEC
Effect conc.:
0.63 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
other: Survival
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
1.9 mg/kg (Based on Mean Measured Sediment Concentrations)
Key result
Duration:
10 d
Dose descriptor:
NOEC
Effect conc.:
2.8 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.63 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
emergence rate
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
1.9 mg/kg (Based on Mean Measured Sediment Concentrations)
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
2.8 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
other: (Development Rate (Male, female & Total))
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
Duration:
10 d
Dose descriptor:
LOEC
Effect conc.:
1.2 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
other: survival
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
4.0 mg/kg (Based on Mean Measured Sediment Concentrations)
Duration:
10 d
Dose descriptor:
LOEC
Effect conc.:
> 2.8 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
biomass
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
>8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
1.2 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
emergence rate
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
4.0 mg/kg (Based on Mean Measured Sediment Concentrations)
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 2.8 mg/kg sediment dw
Conc. based on:
test mat.
Basis for effect:
other: (Development Rate (Male, female & Total))
Remarks on result:
other: (Based on Time-Weighted Mean Measured Sediment Concentrations)
Remarks:
>8.2 mg/kg (Based on Mean Measured Sediment Concentrations)
Results with reference substance (positive control):
The calculated 48-hour EC50 value was 2,700 mg/L based on nominal exposure concentrations. These results and the control survival during testing confirmed the health of the organism culture and suitability of the dilution water for use in testing.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
NOEC (Day-10 Survival): 0.63 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
NOEC (Day-10 Adult Biomass)): 2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
NOEC (Emergence)): 0.63 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
NOEC (Development Rate (Male, female & Total)): 2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Day-10 Survival): 1.2 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Day-10 Adult Biomass)): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Emergence)): 1.2 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
LOEC (Development Rate (Male, female & Total)): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
EC50 (Day-10 Survival): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
EC50 (Emergence)): >2.8 mg/kg (Based on Time-Weighted Mean Measured Sediment Concentrations)
Executive summary:

The midge, Chironomus riparius, was tested in a 28-day exposure period according to OECD guideline 218 to determine the potential effects of the test substance on 10-day survival, adult emergence, and development rate of chironomids exposed during their life cycle.


The testing was performed at nominal sediment concentrations of 0 (control), 0 (vehicle control), 0.63, 1.3, 2.5, 5.0, and 10 mg/kg.


The control organisms met the acceptability criterion for mean percent emergence (i.e., >70%) as specified by the study protocol and the OECD 218 testing guideline. All effects concentrations were based on the day 0 mean measured sediment concentrations and the time-weighted mean measured sediment concentrations. The day 10 survival NOEC and LOEC values, based on the day 0 mean measured sediment concentrations, were 1.9 and 4.0 mg/kg, respectively, with EC10, EC15, and EC50 values of 1.8 mg/kg (95% confidence limits 0.66 – 2.8 mg/kg), 2.5 mg/kg (95% confidence limits 1.2 – 3.7 mg/kg), and >8.2 mg/kg (6.4 – 24 mg/kg), respectively. The day 10 survival NOEC and LOEC values, based on the time-weighted mean measured sediment concentrations, were 0.63 and 1.2 mg/kg, respectively, with EC10, EC15, and EC50 values of 0.58 mg/kg (95% confidence limits 0.24 – 0.90 mg/kg), 0.80 mg/kg (95% confidence limits 0.41 – 1.2 mg/kg), and >2.8 mg/kg (2.1 – 7.9 mg/kg), respectively. The emergence NOEC and LOEC values, based on the day 0 mean measured sediment concentrations, were 1.9 and 4.0 mg/kg, respectively, with EC10, EC15, and EC50 values of 1.9 mg/kg (95% confidence limits 0.86 - 2.7 mg/kg), 2.5 mg/kg (95% confidence limits 1.4 – 3.4 mg/kg), and >8.2 mg/kg (6.6 - 14 mg/kg), respectively. The emergence NOEC and LOEC values, based on the timeweighted mean measured sediment concentrations, were 0.63 and 1.2 mg/kg, respectively, with EC10, EC15, and EC50 values of 0.60 mg/kg (95% confidence limits 0.31 – 0.86 mg/kg), 0.81 mg/kg (95% confidence limits 0.48 – 1.1 mg/kg), and >2.8 mg/kg (2.2 – 4.6 mg/kg), respectively. The day 10 adult biomass and the male, female and total development rate NOEC and LOEC values, based on the day 0 mean measured sediment concentrations (time-weighted mean measured sediment concentrations), were 8.2 and >8.2 mg/kg (2.8 and >2.8 mg/kg), respectively. The EC10, EC15, and EC50 values for adult biomass and the male, female and total development rate data could not be calculated due to the lack of a concentration dependent response trend.