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EC number: 253-649-9 | CAS number: 37743-18-3
- 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
- Study period:
- 2017-01-13 to 2017-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- EC Number:
- 253-649-9
- EC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Cas Number:
- 37743-18-3
- Molecular formula:
- C18H20NO.Br
- IUPAC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: I16DB2126
- Expiration date of the lot/batch: 2018-04-27 (retest date)
- Purity test date: 2016-05-27
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temerature
- Stability under test conditions: not indicated
- Solubility and stability of the test substance in the solvent/vehicle: solubility in water: >500 g/L
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 2.4 mL of volume was taken from the approximate centre of the test vessels. At the end of the exposure period, the replicates were pooled at each concentration before sampling
- Sample storage conditions before analysis: the samples were stored in a freezer. Addionally, reserve samples of 2.4 mL were taken for possible analysis
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: preparation of test solutions started with the highest test concentration of 130 mg/L (100 mg base/L) applying 1 hour of magnetic stirring at room temperature to ensure maximum dissolution of the test item in test medium. This resulted in a clear and colourless solution with a few very finely dispersed undissolved particles that were not considered as disruptive to the test system and therefore not removed. The resulting solution was used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): final test solutions were clear and colourless
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 litres of medium in an all-glass culture vessel.
- Medium: M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no
ACCLIMATION
- Acclimation period: not relevant
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/L CaCO3
- Test temperature:
- 19.5 - 21.6 °C
- pH:
- At t= 0h: 7.9 - 8.0
At t= 48h: 7.8 - 7.9 - Dissolved oxygen:
- At t= 0h: 9.5 - 9.9
At t= 48h: 9.1 - 9.7 - Salinity:
- not relevant
- Nominal and measured concentrations:
- Range finder:
Nominal concentrations (mg/L): 0.13, 1.3, 13 and 130 (0.10, 1.0, 10 and 100 mg base/L)
Final test
Nominal concentrations tested (mg/L): 6.0, 13.0, 28.6, 59.8 and 130 (4.6, 10, 22, 46 and 100 mg base/L)
Measured base concentrations (mg/L) at t=0h: 4.6, 10.5, 23.2, 48.2 and 101
Measured base concentrations (mg/L) at t=48h: 3.35, 7.70, 17.2, 35.2 and 74.6
Measured concentrations were in agreement (100-106%) with nominal at the study start. Measured concentrations decreased to 73-74% of initial at the end of the test. Based on these results, the average exposure concentrations were calculated. Average base concentration: 3.9, 9.0, 20, 41 and 87 mg base/L. Average test item concentration: 5.1, 12, 26, 53 and 113 mg/L. - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 100 mL, glass beaker filled with 80mL
- Aeration: not during the test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): four replicates
- No. of vessels per control (replicates): four replicates
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: x 2.17
- Range finding study: combined limit/range finding study was performed
- Test concentrations:
Limit/range: 0.13, 1.3, 13 and 130 (0.10, 1.0, 10 and 100 mg base/L)
Final test: 6.0, 13.0, 28.6, 59.8 and 130 (4.6, 10, 22, 46 and 100 mg base/L)
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 11 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
- 48h-EC50 = 11 mg/L based on average exposure concentrations. This corresponds with 8.5 mg base/L. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- 24h-EC50 = 0.91 mg/L (with a 95% C.L. between 0.77 and 1.1 mg/L)
- 48h-EC50 = 0.58 mg/L (with a 95% C.L. between 0.49 and 0.67 mg/L)
Th 48h-EC50 was within the expected range of 0.28 to 0.9 mg/L
The sensitivity of the daphnia was within the range determined with the historical data collected at Charles River Den Bosch. - Reported statistics and error estimates:
- Average exposure concentrations were calculated as the geometric means of the concentrations of JNJ-16250351-AAH (T000836) measured in the samples taken at the start (t=0) and at the end (t=48h) of the test.
- The 24h-EC50 was calculated from the geometric mean of the two concentrations with no and complete effects, respectively.
- The 48h-EC50-value was calculated from the weibits of the percentages of affected daphnids and the logarithms of the corresponding average measured test item concentrations using the maximum likelihood estimation method.
The 48h calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of JNJ-16250351-AAH (T000836) to Daphnia magna was determined in a 48-hour static test, according to the OECD guideline 202.
Analyses showed that measured concentrations (based on the base content) were in agreement with nominal at the study start (100-106% relative to nominal). Measured concentrations decreased to 73-74% of initial at the end of the test. Based on these results, the average exposure concentrations were calculated. The range tested based on average measured concentrations was 3.9, 9.0, 20, 41 and 87 mg base/L. This corresponded with 5.1, 12, 26, 53 and 113 mg/L based on the whole test item.
The 48h-EC50 was 11 mg/L based on average exposure concentrations (95% confidence interval between 9.1 and 12 mg/L). This corresponded with 8.5 mg base/L (95% confidence interval between 7.0 and 9.2 mg base/L). The results of the test can be considered reliable without restriction.
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