Registration Dossier
Registration Dossier
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EC number: 944-551-3 | CAS number: -
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- 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:
- guideline study
- Remarks:
- According to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004.04.13
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- Version / remarks:
- 2012.12.18
- GLP compliance:
- yes
- Specific details on test material used for the study:
- The test item is an intermediate. Based on information from the sponsor, the test item is:
The test item is: Hi-OMe (Human Insulin Methylester)
Chemical name: Zinc crystals of HI-OMe
CAS No: Not applicable
Molecular formula: C258H385N65O77S6
Purity: 95-98%
Impurities: Derivatives of HI-OMe, desB30-Insulin, Insulin Human
Percentage of (significant) main impurities:
Typical Concentration: <3.0 % w/w
Concentration Range: 2.0 – 5.0 % w/w
Form: White powder
Water solubility: Dependent of pH
Log Pow: Not possible to perform
Batch Number: EM0Z31503
Manufacturing date: 27.11.2016
Stability: In aqueous solution, stable up to 96 hours at 4°C
Origin: Novo Nordisk A/S - Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples of 5 mL ((0hr, 24hr, 48hr) were collected in 20 mL plastic vials and stored at -20.0 °C
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Juvenile organisms < 24 h old at the beginning of the test
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- renewal of test solution after 24 hours
- Post exposure observation period:
- not included
- Hardness:
- 272 mg CaCO3/L
- Test temperature:
- 19.3 ± 0.1°C
- pH:
- 8.1
- Salinity:
- n.a.
- Conductivity:
- n.a.
- Nominal and measured concentrations:
- Nominal: 0 (control); 20; 40; 75; 150; 300 mg/L
Only the control and the nominal concentrations 20mg/L; 75 mg/L and 300 mg/L were analysed
Meassured (geom. mean concentration): 0.5; 10.5; 19.4; 30.1 mg/L - Details on test conditions:
- Test substance: nominal concentrations: 0 (control); 20; 40; 75; 150; 300 mg/L
Reference substance: K2Cr2O7: 0.2; 0,4; 0.7; 1.0; 1.4; 1.7 and 2.0 mg/L - Reference substance (positive control):
- yes
- Remarks:
- K2Cr2O7
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC10
- Effect conc.:
- > 30.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- no effects were observed during the study
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 30.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other:
- Remarks:
- no effects were observed during the study
- Results with reference substance (positive control):
- Potassium dichromate (K2Cr2O7)
EC50 (24h) = 1.2 [1.1-1.4] mg/L - Validity criteria fulfilled:
- yes
- Conclusions:
- No mortality was observed during the studyand an EC10 (48h) and EC50 (48h) > 30.1 mg/L (geom. mean) were determined.
- Executive summary:
A Daphnia sp. acute immobilisation test (according to OECD Guideline no. 202) and following was conducted applying daphnids <24h old. The study was conducted according to GLP.
Concentrations were not within 20% of the nominal concentration throughout the study. And endpoints are thus reported as geometric mean concentrations (geo. mean conc.)
Organisms were exposed to the test item for 48h and since no mortality was observed during the study an EC10 and EC50 (48h) > 30.1 mg/L (geom. mean) were determined.
Reference
Description of key information
A Daphnia sp. acute immobilisation test (according to OECD Guideline no. 202) and following was conducted applying daphnids <24h old. The study was conducted according to GLP
Organisms were exposed to the test item for 48h and since no mortality was observed during the study an EC10 and EC50 (48h) > 30.1 mg/L (geom. mean) were determined.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 30.1 mg/L
Additional information
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