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EC number: 700-541-9 | CAS number: 1472634-24-4
- 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:
- 30 MAR 2012 - 08 JAN 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD TG 305 (draft 2011)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
- Version / remarks:
- Draft 2011
- Deviations:
- no
- Principles of method if other than guideline:
- Minimised test acc. to OECD 305 draft (2011) with one exposure concentration, only.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Gewerbeaufsichtsamt Hildesheim, 20 October 2010
- Radiolabelling:
- no
- Details on sampling:
- - Sampling intervals/frequency for test organisms:
Test Group: 4 fish on uptake phase days 14 and 28
Control Group: 2 fish on uptake phase day 28
- Sampling intervals/frequency for test medium samples:
Test Group: on days -1, -2 (prior to start of experiment), 0, 7, 14 and 28
Control Group: on days 0 and 28
- Sample storage conditions before analysis: The fish were weighed and stored at ca. -18 °C until analysis, if necessary.
The test item concentration and the control were stabilised by factor 2 with acetonitrile directly after sampling. Further dilutions (factor 2 or factor 4) were made with a 50:50-mixture of HPLC water and acetonitrile. - Vehicle:
- no
- Details on preparation of test solutions, spiked fish food or sediment:
- Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated.
Water parameters:
pH-value: 6.0 - 8.5
Hardness: 10 - 250 mg CaCO3 / L - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Strain: Salmonidae
- Source: Forellenzucht Harkenbleck, Steinbrink 41, 30966 Hemmingen, Germany.
- Age at study initiation: 26 weeks
- Length at study initiation: 8 ± 4 cm
- Weight at study initiation: 2 g
- Weight at termination: 5 g (SD 0.98)
- Method of breeding: -
- Health status: healthy
- Feeding during test: The fish were fed daily in two feedings.
- Food type: Forellenzuchtfutter 0.8 -1.2 mm Teichcenter Rieger
- Amount: The given feed amount (1.5 % of body weight) was documented. The amount of food was adjusted accordingly to the weights of sacrificed fish to account for growth during the experiment.
- Frequency: daily
ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: Forellenzuchtfutter 0.8 -1.2 mm Teichcenter Rieger
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Only rainbow trout from a pool with at least 12 days of acclimation and mortality < 5 % within the last 7 days before the study started were used in the test. - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 28 d
- Hardness:
- 39 - 55 mg CaCO3 / L
- Test temperature:
- 14.8 - 15.2°C (control group); 14.9 - 15.2°C (test group)
- pH:
- 7.11 - 7.80 (control group); 7.22 - 7.80 (test group)
- Dissolved oxygen:
- 93 - 99 % (control group); 97 - 100 % (test group)
- TOC:
- 1.95 mg/L (mean control; range 1.26 - 2.38), 1.84 mg/L (mean test vessel; range 1.28 - 2.35)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: aquaria
- Type: covered by glass tops
- Material, size, headspace, fill volume: glass, 175 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 25 L/h = 5 exchanges / day
- No. of organisms per vessel: 40 per group
- No. of vessels per concentration (replicates): one
- No. of vessels per control / vehicle control (replicates): one
- Biomass loading rate: 0.1 - 1 g fish (wet weight) per L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water
- Holding medium different from test medium: no
- Intervals of water quality measurement: three times per week in all test vessels.
- Intervals of test medium replacement: 5 exchanges/ day
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light / 8 hours dark
- Light intensity: 0.1 - 10 µmol /m^2/s - Nominal and measured concentrations:
- 0.2 mg/L (nominal) corresponding to 0.17 mg/L (mean measured concentration)
- Reference substance (positive control):
- no
- Details on estimation of bioconcentration:
- BASIS INFORMATION
- Measured concentrations in fish and media
BASIS FOR CALCULATION OF BCF
- Estimation software: GraphPad Prism, GRAPHPAD SOFTWARE, INC. + Excel, MICROSOFT CORPORATION
- Results: 19 and 20 - Lipid content:
- 3.73 %
- Time point:
- start of exposure
- Remarks on result:
- other: mean
- Lipid content:
- 5.14 %
- Time point:
- end of exposure
- Remarks on result:
- other: mean
- Conc. / dose:
- 0.2 µg/L
- Temp.:
- 15 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 19 dimensionless
- Basis:
- whole body w.w.
- Calculation basis:
- other: calculated from uptake day 14
- Conc. / dose:
- 0.2 µg/L
- Temp.:
- 15 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 20 dimensionless
- Basis:
- whole body w.w.
- Calculation basis:
- other: calculated from uptake day 28
- Conc. / dose:
- 0.2 µg/L
- Temp.:
- 15 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 21 dimensionless
- Basis:
- normalised lipid fraction
- Calculation basis:
- other: calculated from uptake day 14
- Conc. / dose:
- 0.2 µg/L
- Temp.:
- 15 °C
- pH:
- 7.5
- Type:
- BCF
- Value:
- 19 dimensionless
- Basis:
- normalised lipid fraction
- Calculation basis:
- other: calculated from uptake day 28
- Remarks on result:
- not measured/tested
- Remarks:
- No depuration phase was carried out, since no significant uptake was observed. Thus, no depuration rates were calculated.
- Remarks on result:
- not measured/tested
- Remarks:
- No significant uptake of the test item in fish was observed
- Details on results:
- - Mortality of test organisms: no
- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: no abnormalities
- Organ specific bioaccumulation: no
- Bound residues forming a plateau: no
- Mortality and/or behavioural abnormalities of control: no abnormalities
- Loss of test substance during test period: no
- Results with vehicle control: no abnormalities - Validity criteria fulfilled:
- yes
- Conclusions:
- The bioconcentration factors (at any time and lipid normalised, calculated on day 28) determined in this study with the test item were 20 and 19, respectively. The result is below the regulatory value of concern regarding bioaccumulation (< 500).
- Executive summary:
Study Design
A minimised bioaccumulation study with rainbow trout (Oncorhynchus mykiss) was conducted to determine the bioconcentration potential of the test material. The GLP-study was conducted according to OECD Guideline 305 (Draft 2011).
A flow-through test with 2 groups (one control group and one exposure group) and an exposure (uptake phase) of 28 days was carried out. The depuration phase was waived, since the measured concentration in fish was < 50 µg / g fish
Analytical verification:
The concentration of the test material was determined via LC-MS/MS analysis. Four fish were sampled on uptake phase days 14 and 28 from the exposure group. Two fish were sampled from the control group on uptake phase day 28. Samples of the aqueous phase were taken and analysed on uptake phase days -1, -2, 0, 7, 14 and 28 from the exposure group and on uptake phase day 0 and 28 from the control group. The lipid content of the fish was determined at the start and end of the study using 2 fish for the exposure group and 1 fish of the control group.
Evaluation:
Fish growth rates have been calculated. No significant uptake of the test item in fish was observed. Therefore, no uptake / depuration rates and no bioconcentration factors (steady state and kinetic, respectively) have been calculated. Bioconcentration factors at any sampling date during the uptake phase have been calculated based on fish body weight.
Results
Uptake phase:
The aqueous concentrations were stable in the range of 74 - 96 % (Day 0 - 28) of the nominal values throughout the uptake phase. There was no increase of the test item concentrations observed in the fish. All the measured concentrations in fish were below 50 µg / g fish.
Depuration phase:
No depuration rates were calculated since no significant uptake was observed. No depuration phase was carried out.
Bioconcentration factors:
The bioconcentration factors (at any time and lipid normalised, calculated on day 28) determined in this study with the test item were 20 and 19, respectively. The result is below the regulatory value (< 500) of concern regarding bioaccumulation.
Validity:
The validity criteria regarding temperature, oxygen saturation, test item concentrations in water and mortality were fulfilled.
Conclusion
The bioconcentration factors (at any time and lipid normalised, calculated on day 28) determined in this study with the test item were 20 and 19, respectively. The result is below the regulatory value (< 500) of concern regarding bioaccumulation.
Reference
Mean concentrations determined in fish were 3.2 ± 0. 7 μg/g on day 14 of the uptake phase and 3.4 ± 1.1 μg/g on day 28. These values resulted in lipid normalized concentrations of 3.6 ± 0.8 and 3.3 ± 1 .1 μg/g body weight.
No significant uptake was observed in fish. All measured concentrations in fish were below 50 μg/g fish (the value which would have triggered a depuration phase). The highest concentration was found in fish on day 28 of the uptake phase with 4.98 μg/g.
Description of key information
Key, bioaccumulation in fish, O. mykiss, OECD 305, GLP, 28 d, BCF = 20
Key value for chemical safety assessment
- BCF (aquatic species):
- 20 dimensionless
Additional information
Study Design
A minimised bioaccumulation study with rainbow trout (Oncorhynchus mykiss) was conducted to determine the bioconcentration potential of the test material. The GLP-study was conducted according to OECD Guideline 305 (Draft 2011).
A flow-through test with 2 groups (one control group and one exposure group) and an exposure (uptake phase) of 28 days was carried out. The depuration phase was waived, since the measured concentration in fish was < 50 µg / g fish
Analytical verification:
The concentration of the test material was determined via LC-MS/MS
analysis. Four fish were sampled on uptake phase days 14 and 28 from the
exposure group. Two fish were sampled from the control group on uptake
phase day 28. Samples of the aqueous phase were taken and analysed on
uptake phase days -1, -2, 0, 7, 14 and 28 from the exposure group and on
uptake phase day 0 and 28 from the control group. The lipid content of
the fish was determined at the start and end of the study using 2 fish
for the exposure group and 1 fish of the control group.
Evaluation:
Fish growth rates have been calculated. No significant uptake of the
test item in fish was observed. Therefore, no uptake / depuration rates
and no bioconcentration factors (steady state and kinetic, respectively)
have been calculated. Bioconcentration factors at any sampling date
during the uptake phase have been calculated based on fish body weight.
Results
Uptake phase:
The aqueous concentrations were stable in the range of 74 - 96 % (Day 0
- 28) of the nominal values throughout the uptake phase. There was no
increase of the test item concentrations observed in the fish. All the
measured concentrations in fish were below 50 µg / g fish.
Depuration phase:
No depuration rates were calculated since no significant uptake was
observed. No depuration phase was carried out.
Bioconcentration factors:
The bioconcentration factors (at any time and lipid normalised,
calculated on day 28) determined in this study with the test item were
20 and 19, respectively. The result is below the regulatory value (<
500) of concern regarding bioaccumulation.
Validity:
The validity criteria regarding temperature, oxygen saturation, test
item concentrations in water and mortality were fulfilled.
Conclusion
The bioconcentration factors (at any time and lipid normalised, calculated on day 28) determined in this study with the test item were 20 and 19, respectively. The result is below the regulatory value (< 500) of concern regarding bioaccumulation.
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