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EC number: 204-249-8 | CAS number: 118-42-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- guideline study
- Justification for type of information:
- Guideline study to GLP certification with no deviations.
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydroxychloroquine
- EC Number:
- 204-249-8
- EC Name:
- Hydroxychloroquine
- Cas Number:
- 118-42-3
- Molecular formula:
- C18H26ClN3O
- IUPAC Name:
- 2-({4-[(7-chloroquinolin-4-yl)amino]pentyl}(ethyl)amino)ethan-1-ol
- Test material form:
- solid
- Remarks:
- white solid powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
HYDROXYCHLOROQUINE (CAS N°118-42-3) – Batch 5U054 (Synonym: PLAQUENIL)
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations:
Nominal concentrations were 6.25, 12.5, 25, 50, 100 mg/l
Geometric mean concentrations were 6.76, 11.9, 21.8, 44.8, 105.0 mg/l
- Sampling method:
The quantification of Hydroxychloroquine was performed according to the validated analytical
method to check test item concentrations at T0 and T48h
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A stock solution of test item was prepared by ultrasonic dissolution
of the test item in the test media.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Age at study initiation (mean and range, SD): Between 6 and 24 hours old
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- None
- Post exposure observation period:
- None
Test conditions
- Hardness:
- No data
- Test temperature:
- 20°C +/- 2°C across the test concentrations, replicates and test duration.
- pH:
- 7.8 to 9 across the test concentrations, replicates and test duration.
- Dissolved oxygen:
- 7.5 to 8.3 across the test concentrations, replicates and test duration.
- Salinity:
- Not applicable
- Conductivity:
- No data
- Nominal and measured concentrations:
- Nominal concentrations were 6.25, 12.5, 25, 50, 100 mg/l
Geometric mean concentrations were 6.76, 11.9, 21.8, 44.8, 105.0 mg/l - Details on test conditions:
- TEST SYSTEM
- Test vessel: Tests were performed in 10 mL polystyrene multiwell plate.
- Volume of solution: 10 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
OTHER TEST CONDITIONS
- Adjustment of pH: Not performed
- Photoperiod: Test conducted in dark - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 11.9 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 6.76 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 8.47 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 14 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- None
- Results with reference substance (positive control):
- EC50-24h K2Cr2O7 between 0.6 and 2.1 mg/L:
March 23rd, 2016 : EC50-24h = 1.39 mg/L [1.31 – 1.47] - Reported statistics and error estimates:
- The EC50 at 48h for immobilisation with confidence limits and graphs of the fitted model
used for their calculation, the slopes of the dose-response curves are reported. Data was analysed by an appropriate statistical method (Probit analysis
to calculate the slopes of the curves and the EC50 with 95% confidence limits (p = 0.95)).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The reliable (K1) OECD 202 Guideline study found that acute toxicity was observed in Daphnia magna resulting in a 48-hr EC50 of 14.0 mg/l based on measured geometric mean.
- Executive summary:
The reliable (K1) OECD 202 Guideline study was performed to GLP standards and met validity criteria. The study was performed using five test concentrations ranging from 6.25 to 100 mg/L nominal concentration. The measured concentrations were between 72.7 % and 107.4 % of the nominal concentration at T0, and between 104.6 % and 109.1 % of nominal at 48 hrs. Therefore, the determination of the results was based on the geometric mean of the measured concentrations.
Results according to OECD 202 test guideline:HYDROXYCHLOROQUINE
BPL15-0032.001EC50-48h
Confidence limits 95%14.0 mg/L
(12.9-15.1 mg/L)EC10-48h
Confidence limits 95%8.47 mg/L
(7.78-9.16 mg/L)NOEC 6.76 mg/L LOEC 11.9 mg/L ECX-48h: Effective Concentration corresponding to X% of mobility inhibition in the 48-hours test.
NOEC: No Observed Effect Concentration.
LOEC: Lowest Observed Effect Concentration.
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