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EC number: 436-060-3 | CAS number: - FC 84508 PK
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Jul. 23, 2004 to Oct. 25, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Bioconcentration test of chemical substances in fish and shellfish (Yakushokuhatsu No.1121002, Heisei 15.11.13 Seikyoku, No.2, Kanpokihatsu No.031111002, November 21, 2003)
- Deviations:
- no
- GLP compliance:
- yes
- Radiolabelling:
- no
- Details on sampling:
- - Sampling intervals/frequency for test organisms: Day 5, 14, 28, 42 and 60 of the exposure period
- Sampling intervals/frequency for test medium samples: Day 0, 5, 14, 21, 28, 35, 42, 49 and 60 of the exposure period
- Sample storage conditions before analysis: Yes - Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Municipal tap water was treated with activated charcoal. The dechlorinated water was aerated and maintained at 24 °C. This dilution water was checked half-yearly and confirmed to suit aquatic living resources.
- Controls: Yes, dilution water
- Chemical name of vehicle: Dimethylformamide (DMF)
- Concentration of vehicle in test medium: Control - 21 ppm DMF; 0.01 mg/L test substance - 25 ppm DMF; 0.1 mg/L test substance - 21 ppm DMF
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp
- Source: Niikura Fish Farm, 1211, Shimoya, Isehara-city, Kanagawa, Japan
- Age at study initiation (mean and range, SD): About a year after hatching
- Length at study initiation (length definition, mean, range and SD): 8±4 cm
- Weight at study initiation (mean and range, SD): Approx 5 g
ACCLIMATION
- Acclimation period: ≥ 2 wk
- Acclimation conditions (same as test or not): Same
- Type and amount of food: Baby gold, 2 % of the fish weight
- Health during acclimation (any mortality observed): Mortality= < 5 % - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 60 d
- Hardness:
- 59 mg/L as CaCO3
- Test temperature:
- 24±2 °C
- pH:
- 6.0-8.5
- Dissolved oxygen:
- ≥60% of the saturation (≥ 5 mg/L at 24 °C)
- TOC:
- No data
- Salinity:
- No data
- Details on test conditions:
- TEST SYSTEM
- Aeration: Continuous
- Type of flow-through (e.g. peristaltic or proportional diluter): Continuous flow-through diluter system
- No. of organisms per vessel: 44 fish in 50 L test water in treatment group, 28 fish in 50 mL test water in Control group
- No. of vessels per concentration (replicates): Three
- No. of vessels per control / vehicle control (replicates): Three
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Yokohama municipal tap water treated with activated charcoal
- Chlorine: <0.02 mg/L
- Alkalinity: 44 mg/L
- Ca/mg ratio: 4.22/1
- Conductance: 156 µ S/cm
OTHER TEST CONDITIONS
- Photoperiod: 16 h/day
- Light intensity: Hf fluorescent lamp with wavelengths of 400-700 nm - Nominal and measured concentrations:
- Nominal: 0 (HCO-40 4 mg/L, Dimethylformamide=21 ppm (v/v)), 0.01 (HCO-40 0.4 mg/L, Dimethylformamide=25 ppm (v/v)), 0.1 mg/L (HCO-40 4 mg/L, Dimethylformamide=21 ppm (v/v))
- Reference substance (positive control):
- not specified
- Details on estimation of bioconcentration:
- BASIS FOR CALCULATION OF BCF
BCF=Cf/Cw
steady-state bioconcentration factor (BCFss)= BCFss= Cfs/Cws - Lipid content:
- ca. 5.3 %
- Time point:
- start of exposure
- Remarks on result:
- other: (n=3; 4.9-5.7 %)
- Lipid content:
- ca. 4 %
- Time point:
- end of exposure
- Remarks on result:
- other: (n=3, 3.7-4.3 %)
- Type:
- BCF
- Value:
- ca. 38 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 60 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Conc.in environment / dose:0.1 mg/L nominal
- Type:
- BCF
- Value:
- ca. 236 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 60 d
- Calculation basis:
- steady state
- Remarks on result:
- other: Conc.in environment / dose:0.01 mg/L nominal
- Type:
- BCF
- Value:
- >= 19 - <= 42 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 60 d
- Remarks on result:
- other: Variation of individual time-specific BCF values
- Remarks:
- Conc.in environment / dose:0.1 mg/L nominal
- Type:
- BCF
- Value:
- >= 94 - <= 269 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 60 d
- Remarks on result:
- other: Variation of individual time-specific BCF values
- Remarks:
- Conc.in environment / dose:0.01 mg/L nominal
- Details on kinetic parameters:
- Not investigated
- Metabolites:
- Not investigated
- Results with reference substance (positive control):
- Not applicable
- Details on results:
- - Mortality of test organisms: No
- Behavioural abnormalities: No
- The individual time-specific bioconcentration factors (BCF) of the test substance varied between 19 and 42 at the high concentration level, and from 94 to 277 at the low concentration level.
- BCF at steady state (BCFss) was 38 at the high concentration level and 236 at the low concentration level (in the study report itself an erroneous BCFss of 244 is documented, due to a calculation error for the mean aqueous test substance concentration at the steady state) - Reported statistics:
- No data
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, the bioconcentration factors (BCF) of the test substance were 19-42 at high concentration level, and 94 -277 at low concentration level. BCF at steady state (BCFss) were 38 at high concentration level and 236 at low concentration level.
- Executive summary:
The study was conducted evaluate the potential of the test substance to accumulate in the tissues of the carp in accordance with "Test Method Relating to New Chemical Substances Bioconcentration test of chemical substances in fish and shellfish, (Yakushokuhatsu No.1121002, Heisei 15.11.13 Seikyoku, No.2, Kanpokihatsu No.031111002, November 21, 2003)" and in compliance with GLP.
Fish were exposed to nominal concentrations 0, 0.01 and 0.1 mg/L of test substance in test water using continuous flow-through diluter system (800 L/day) for 60 d.
Prior to the bioconcentration test, an acute toxicity test with Medaka was conducted in accordance with the OECD guideline 203 to confirm that the nominal concentrations of the bioconcentration test were less than a hundredth and a thousandth of the 96 h LC50. Concentrations of the test substance in the test water were not measured, and any effects were evaluated on the basis of nominal concentrations. No mortality occurred at the limit test concentration hence the 96-h LC50 of the test substance was >10 mg/L.
HPLC was used for the analysis of test substance in test media and test fish.
The lipid content was determined to be 5.3 and 4.0 % at the start and end of the experiment, respectively.
Steady state was reached at day 28 in both the low and the high test concentration. Under the test conditions, the steady state (BCFss) was 38 at the high concentration level and 236 at the low concentration level.
Reference
The nominal concentration in bioconcentration test was confirmed to be less than a hundredth and a thousandth of the 96-h LC50.
Description of key information
The steady-state bioconcentration factor (BCFss) was 38 at the high concentration level and 236 at the low concentration level. In an conservative approach, the higher values is adopted for the chemical safety assessment.
Key value for chemical safety assessment
- BCF (aquatic species):
- 236 dimensionless
Additional information
The study was conducted evaluate the potential of the test substance to accumulate in the tissues of the carp in accordance with the Test Method Relating to New Chemical Substances Bioconcentration test of chemical substances in fish and shellfish, (Yakushokuhatsu No.1121002, Heisei 15.11.13 Seikyoku, No.2, Kanpokihatsu No.031111002, November 21, 2003) and in compliance with GLP.
Fish were exposed to nominal concentrations of 0.01 and 0.1 mg/L of test substance in test water, and a blank control, using continuous flow-through diluter system (800 L/d) for 60 days.
Prior to the bioconcentration test, an acute toxicity test with Medaka was conducted in accordance with the OECD guideline 203 to confirm that the nominal concentrations of the bioconcentration test were less than a hundredth and thousandth of the 96 h LC50. Concentrations of the test substance in test water were not measured in this acute toxicity test hence any effects were evaluated on the basis of nominal concentrations. There was not mortality at the limit test concentration of 10 mg/L, therefore the 96-h LC50 of the test substance was determined to be > 10 mg/L.
In the bioaccumulation test, HPLC was used for the analysis of test substance in test media and test fish. The lipid content was determined to be 5.3 and 4.0 % at the start and end of the experiment, respectively.
Steady state was reached after 28 days at both the low and the high test concentration. The BCF at steady state (BCFss) was 38 at the high concentration level and 236 at the low concentration level (Oshioka, 2004).
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