Registration Dossier

Administrative data

Endpoint:
sediment toxicity: short-term
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Justification for type of information:
Performed according to PARCOM guidelines, accepted fof assessment of off-shore chemicals

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ASTM E1367 (10-day Static Sediment Toxicity Test (Media: Sediment-marine))
Version / remarks:
PARCOM 2005
Principles of method if other than guideline:
According to PARCOM
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Commercial grade containing approximately 45% actives
Specific details on test material used for the study:
40% actives commercial grade material

Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
yes
Remarks:
Artificial seawater, 25 - 35% salinity
Details on sediment and application:
Natural sediments from Irish sea at the same sites as the Coropium were taken

Test organisms

Test organisms (species):
Corophium volutator
Details on test organisms:
Collected from Irish Sea at same site as sediment used.
Study started 2 days after collection

Study design

Study type:
laboratory study
Test type:
static
Water media type:
saltwater
Type of sediment:
natural sediment
Limit test:
no
Exposure duration
Duration:
10 d
Exposure phase:
total exposure duration

Test conditions

Nominal and measured concentrations:
Range-finder up to 10 000 mg/kg dry weight of sediment, expressed as 40% actives supplied (4000 mg/kg actives)
Main study 0, 1000, 1778, 3162, 5623 and 10 000 mg/kg, expressed as 40% actives (up to 4000 mf/kg actives)
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
10 d
Dose descriptor:
EC0
Effect conc.:
> 4 000 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
10 d
Dose descriptor:
EC0
Effect conc.:
> 10 000 mg/kg sediment dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Mortality rates of 7 - 33% were seen in the various groups, but this was not dose concentration related, with control group showing 21% mortality (marginally higher than recommended limit of 20%.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
although control mortality of 21% was marginally higher than recommended limit of 20%
Conclusions:
Considered non-hazardous in sediments