Registration Dossier
Registration Dossier
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EC number: 207-365-7 | CAS number: 465-65-6
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)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Naloxone
- EC Number:
- 207-365-7
- EC Name:
- Naloxone
- Cas Number:
- 465-65-6
- Molecular formula:
- C19H21NO4
- IUPAC Name:
- (1S,5R,13R,17S)-10,17-dihydroxy-4-(prop-2-en-1-yl)-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one
1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- HPLC-UV
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Female Daphnia magna, clone 5; 5.25 to 23.25 hours old
The daphnids introduced in the test were taken from ibacon's in-house laboratory culture
Study design
- Test type:
- semi-static
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20 to 21°C
- pH:
- 7.4 to 8.5
- Dissolved oxygen:
- 7.8 to 9 mg/L
- Nominal and measured concentrations:
- A filtrate of 100 mg test item/L and dilutions of 1:2, 1:4, 1:8, 1:16 of this filtrate corresponding to the following nominal concentrations:
100, 50, 25, 12.5 and 6.25 mg test item/L and a control
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- mobility
- Details on results:
- The mobility of the daphnids was determined by visual observation after 24 and 48 hours. Those animals that are not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile (even if they could still move their antennae)
- Results with reference substance (positive control):
- Control Immobilisation Rate was 0 % and furthermore no daphnid showed signs of disease or stress; thus the validity criterion was met.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-hour LOEC was determined to be > 100 mg test item/L and the 48-hour EC50 value was determined to be > 100 mg test item/L.
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