Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
, see "Principles of method if other than guideline"
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
yes
Remarks:
, see "Principles of method if other than guideline"
Principles of method if other than guideline:
The following deviation from the Guideline was documented:
The concentration of methanol in the solvent control was higher than demanded in the
guideline. As no significant immobilisation observed during the test, this deviation was
stated as uncritical.
The deviation was signed and assessed by the study director on 29. Apr. 2009.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Sa 190 / SAT-No. 080004
Batch-No.: Huc-SA-9370-190
CAS-No.: 1001161-63-2
Molecular formula: C27H53NO2
Molecular weight: 423.72 g/mol
Purity: >98 % (NMR)
Homogeneity: not stated
Vapour pressure: at room temperature not volatile
Stability: in H2O, DMSO; EtOH, acetone, CH3CN unknown, stable in olive oil
Solubility: in H2O < 0.1 g/L, DMSO; EtOH, acetone, CH3CN unknown
Production date: 22. Oct. 2007
Expiry date: 22. Feb.2010
Storage: room temperature20 ± 5 °C, dark, dry

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
12.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks on result:
other: (limit of water solubility)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
12.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks on result:
other: (limit of water solubility)
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 12.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks on result:
other: (limit of water solubility)
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 12.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks on result:
other: (limit of water solubility)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
All validity criteria were met. For the estimation of the EC50 of the positive control, the fit
showed sufficient statistical correspondence of the data with the dose-response-equation.
The 24h-EC50i of potassium dichromate was determined as 1.6 mg/L, lying within the demanded
range of 0.6 - 1.7 mg/L.
No significant toxicity was observed in the control, the solvent control and the treatment.
The analytical determinations of the test item showed that the limit of water solubility in the
test solution was present during the test. The mean of the measured concentrations is calculated
and used as effective concentration for the determination of the results.
All blanks were contaminated with test item Sa190 and all"24 hours" samples were contaminated
with test item Sa 163. This might be caused by contaminated amber bottles. As
both test items show adsorption to glass, the cleaning of the amber bottles was probably
insufficient. As no significant immobilisation was observed during the test, this can be
stated as uncritical.
The result of the test is considered valid.