Registration Dossier
Registration Dossier
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EC number: 844-009-5 | CAS number: 167173-85-5
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
- Cas Number:
- 167173-85-5
- Molecular formula:
- C26H30N2O9
- IUPAC Name:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Constituent 1
- Specific details on test material used for the study:
- Substance name: X642188
Lot#: SYN-FS08353-048
Purity: 99%
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Vehicle:
- yes
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 146 mg CaCO3/L
- Test temperature:
- 14.8 to 15.3°C
- pH:
- 8.1 to 8.3
- Dissolved oxygen:
- 7.1 to 9.3 mg/L (73 to 96% saturation)
- Conductivity:
- 345 μS
- Nominal and measured concentrations:
- Nominal: 0 (Control), 0 (Vehicle Control), 0.0038, 0.0075, 0.015, 0.030, and 0.060 mg/L
Measured: < MQL (control), < MQL (vehicle control), 0.0011, 0.0017, 0.0056, 0.0095, and 0.015 mg/L
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.007 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI: 0.0054 and 0.0095 mg/L
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.008 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI: 0.0071 and 0.0099 mg/L
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.008 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI: 0.0069 and 0.0089 mg/L
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.008 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI: 0.0069 and 0.0089 mg/L
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.006 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- 96 h LC50 (Oncorhynchus mykiss): 0.0073 mg/L (95% CI: 0.0054 and 0.0095 mg/L)
- Executive summary:
The test substance was evaluated for acute toxicity test with Rainbow Trout (Oncorhynchus mykiss) under 96-hour flow-through test conditions. The test was conducted according to OECD guideline 203.
The nominal concentrations used were 0 (Control), 0 (Vehicle Control), 0.0038, 0.0075, 0.015, 0.030, and 0.060 mg/L, corresponding to mean measured concentrations of <MQL (control), <MQL (vehicle control), 0.0011, 0.0017, 0.0056, 0.0095, and 0.015 mg/L, respectively.
After 96 hours there was no mortality in the control, vehicle control, or the 0.0011 and 0.0017 mg/L test substance treatments. Mortality was 14%, 86%, and 100% in the 0.0056, 0.0095, and 0.015 mg/L, respectively. The 24-, 48-, and 72-hour LC50, based on mean measured concentrations and using the untrimmed Spearman-Karber method, was calculated to be 0.0084, 0.0078, and 0.0078 mg/L respectively. The 96-hour LC50, based on mean measured concentrations and using the probit method, was calculated to be 0.0073 mg/L. The slope of the 96-hour concentration-response line was 9.44. The 96-hour NOEC, based on mean measured concentrations, was 0.0056 mg/L.
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