Registration Dossier

Administrative data

Endpoint:
sediment toxicity: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug - Dec 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 218 (Sediment-Water Chironomid Toxicity Test Using Spiked Sediment)
Deviations:
no
Principles of method if other than guideline:
Not relevant
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): Sorafenib
- Analytical purity: 98.5%
- Lot/batch No.: BXA44KS

Sampling and analysis

Analytical monitoring:
yes

Test substrate

Vehicle:
no

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
Limit test:
no
Exposure duration
Duration:
28 d
Exposure phase:
total exposure duration

Results and discussion

Effect concentrations
Duration:
28 d
Dose descriptor:
EC50
Effect conc.:
2.85 mg/kg sediment dw
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
emergence rate

Any other information on results incl. tables

Emergence ratio showed a clear dose-response relationship compared to the solvent control after a 28 d exposure period. Development rate was not inhibited at 10 mg/kg dry sediment. Measured initial concentrations were within ± 20% of the nominal concentrations (mean recovery: 87.2% of nominally applied test item). Therefore, the biological effect concentrations were expressed based on the nominal concentrations. After 28 days, mean recovery of applied test item was 89.3%.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The EC50 for emergence ratio was found to be 2.85 mg/Kg sediment.
Executive summary:

The aim of this study was to determine the lethal and sublethal effects of the test item on the larvae of Chironomus riparius. To achieve this aim, first-instar larvae were exposed in a sediment-water system to a series of test item concentrations applied to the sediment phase of a sediment-water system. Test vessels without the addition of the test item served as controls. The test item was spiked into the formulated sediment, and the test organisms were subsequently introduced into the test vessels in which the sediment and water concentrations had been equilibrated for 2 days. The test animals were exposed to the systems for a period of 28 days which is considered to be sufficient to assess the impact of the test item on full maturation of the larvae to adult midges. The larvae were fed during the exposure period to ensure that the animals grew and emerged under control conditions. Endpoints based on emergence ratio (number of emerged adults compared with number of larvae introduced per vessel) and development rate (time elapsed between introduction of larvae to treated vessels and emergence of adults) were assessed in comparison to a control. Parameters were the total number of emerged adults and the development rate. In addition, different sensitivities of sexes were assessed. Since there were no indications of significantly different sensitivities of sexes, male and female results were pooled for statistical analysis. The data obtained concerning the toxicological effects of the test item on the test organisms were used to determine an ECx (e.g. EC50, EC20, EC15). In addition, the lowest observed effect concentration (LOEC) and hence the no observed effect concentration (NOEC) were determined. To verify the nominally applied concentrations, samples were taken from overlying water, pore water and sediment and analytically measured. The samples designated for chemical analysis were shipped to the analytical Test Site and analysed under the responsibility of the Principal Investigator for Analysis.

Emergence ratio showed a clear dose-response relationship compared to the solvent control after a 28 d exposure period. Development rate was not inhibited at 10 mg/kg dry sediment. Measured initial concentrations were within ± 20% of the nominal concentrations (mean recovery: 87.2% of nominally applied test item). Therefore, the biological effect concentrations were expressed based on the nominal concentrations. After 28 days, mean recovery of applied test item was 89.3%.