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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
number of replciates lower than recommended in guideline, less soil per replicate

Data source

Reference
Reference Type:
publication
Title:
Acute toxicological effects on the earthworm Eisenia fetida of 18 common pharmaceuticals in artificial soil
Author:
M Rosa Pino, Jonatan Val, Ana M Mainar, Estefanía Zuriaga, Cecilia Español, Elisa Langa
Year:
2015
Bibliographic source:
Science of the Total Environment 518–519 (2015) 225–237

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Version / remarks:
1984
Deviations:
yes
Remarks:
3 replicates instead of 4; 500 g soil instead of 750 g soil per replicate
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ibuprofen
EC Number:
239-784-6
EC Name:
Ibuprofen
Cas Number:
15687-27-1
Molecular formula:
C13H18O2
IUPAC Name:
2-(4-isobutylphenyl)propanoic acid
Specific details on test material used for the study:
Purity: 100%

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: separate assay without earthworms: 0.0100 g/5 g sampled after 14 d

Test substrate

Vehicle:
no

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
annelids

Study design

Study type:
laboratory study
Substrate type:
artificial soil
Remarks:
standardized OECD soil substrate: industrial fine sand, sphagnum peat, and kaolin clay in a 7:1:2 ratio, water added at amount of 35% of soil dw
Limit test:
no
Total exposure duration:
14 d

Test conditions

Test temperature:
20±2 °C
Moisture:
80-85% air humidity
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 1 L polypropylene rectangular jars with lid
- Amount of soil or substrate: 500 g ww
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 3
- No. of replicates per control: 3

OTHER TEST CONDITIONS
- Photoperiod: constant light
- Light intensity: 400-800 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- mortality after 7 and 14 d

TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations: 0–10–200–1000 mg/kg soil dw
- Results used to determine the conditions for the definitive study: not reported
Nominal and measured concentrations:
nominal: 0, 15, 30, 50, 60, 80, 100, 150 mg/kg dw soil (stability verified in separate assay)
Reference substance (positive control):
yes
Remarks:
Chloroacetamide

Results and discussion

Effect concentrations
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
64.8 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 58.49–71.78 mg/kg soil dw, P < 0.0001, R² of the regression = 0.961
Details on results:
- Mortality in negative control at end of exposure period: < 10%
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: 100% mortality at 24 mg/kg soil dw
- Other:
Reported statistics and error estimates:
log Probit analysis

Applicant's summary and conclusion