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Diss Factsheets
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EC number: 201-602-8 | CAS number: 85-40-5
- 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:
- other: GLP compliant study conducted to internationally recognised test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,2,3,6-tetrahydrophthalimide
- EC Number:
- 201-602-8
- EC Name:
- 1,2,3,6-tetrahydrophthalimide
- Cas Number:
- 85-40-5
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): THPI D4
- Physical state: Solid
- Analytical purity: 97.91%
- Lot/batch No.: STI4208324
- Expiration date of the lot/batch: 2009-11-21
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature, protected from light and humidity
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100 mg/L
- Sampling method: Direct sampling
- Sample storage conditions before analysis: 6 Deg C +/- 2 Dec C
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct addition to dilution water (medium) followed by ultrasonification for 10 minutes
- Controls: Diution water (medium)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None used
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None observed
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: STRAUS (Clone 5)
- Source: Institut fur Wasser, Boden und Lufthygiene
- Age at study initiation (mean and range, SD): 2-24 hours
- Method of breeding: Colony maintained at test facility in 2-3 L capacity glass vessels with 1.8 L Elendt M4 medium in an incubator at 20+/- 2 Dec C and 16 hours illumination/day. Fed 5 x weekly with unicellular green algae
- Feeding during test
- Food type: None
ACCLIMATION
- Acclimation period: Minimum of 2 hours
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: None
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 265 mg/L as CaCO3
- Test temperature:
- 20 - 21 Dec C
- pH:
- 7.50 - 7.98
- Dissolved oxygen:
- 7.36 - 8.63 mg/L
- Nominal and measured concentrations:
- Nominal - 100 mg/L (97.9 mg/L when corrected for purity)
Measured - at test start (0 hours) 91.8 mg/L; at test end (48 hours) 89.5 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 50mL capacity glass beakers
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Glass, 4 cm ID x 7 cm, fill volume 20 mL
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): None
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: As specified in Council Refgulation 440/2008 Method C2, Appendix 2
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light : 8 hours dark / day
- Light intensity: Maximum 0.02 E.m-2/second
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation assessed 24 and 48 hours after start of exposure
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable (limit test)
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - lack of effects at 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: None observed
- Mortality of control: None
- Other adverse effects control: None observed
- Abnormal responses: None observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None observed
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50: 24 hour EC50 = 1.66 mg/L (95% confidence interval 1.50 - 1.83 mg/L
:
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The substance has no effect on Daphnia following 48 hours exposure at a concentration of 100 mg/L
- Executive summary:
The substance has no effect on Daphnia following 48 hours exposure at a concentration of 100 mg/L
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