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Diss Factsheets
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EC number: 284-325-5 | CAS number: 84852-15-3
- 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
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:
- weight of evidence
- Study period:
- unknown
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific standards acceptable for assessment. Test water characteristics and test organism survival information is missing.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 305 (Bioconcentration: Flow-through Fish Test)
- Deviations:
- yes
- Remarks:
- tested only one concentration
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- This is a published study which does not state the GLP status of the study or the laboratory, but the study is scientifically acceptable and is peer reviewed.
- Specific details on test material used for the study:
- No futher details provided
- Radiolabelling:
- yes
- Details on sampling:
- Water samples were collected daily.
Organism sampling occurred on days 2, 4, 8, 16, 18, 20, 24, 32, 48 and stored in glass jars at -20 °C until analysis. - Vehicle:
- yes
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): 20 mg/L - Test organisms (species):
- Gasterosteus aculeatus
- Details on test organisms:
- TEST ORGANISM
- Common name: stickleback
- Source: not provided
- Age at study initiation (mean and range, SD): not provided
- Feeding during test: yes
- Food type: mussels
- Frequency: once or twice a week
ACCLIMATION
- Acclimation period: not provided - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: marine
- Total exposure / uptake duration:
- 16 d
- Total depuration duration:
- 32 d
- Hardness:
- not provided
- Test temperature:
- 10-13 °C in Test 1
8-13 °C in Test 2 - pH:
- Not provided
- Dissolved oxygen:
- Not provided
- TOC:
- Not provided
- Salinity:
- Not provided
- Conductivity:
- Not provided
- Details on test conditions:
- TEST SYSTEM
- Test vessel: aquaria
- Material, size, headspace, fill volume: 10 L
- Type of flow-through (e.g. peristaltic or proportional diluter): not given
- Renewal rate of test solution (frequency/flow rate): 85 ml/min
- No. of organisms per vessel: 110
- No. of vessels per concentration (replicates): 3
- No. of vessels per control / vehicle control (replicates): not given
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: saltwater
- Intervals of water quality measurement: not provided - Nominal and measured concentrations:
- Average measured cocentrations of 4.8 ug/L in Test 1 and 4.9 ug/L in Test 2
- Reference substance (positive control):
- not specified
- Details on estimation of bioconcentration:
- BCF was not estimated prior to testing.
BCF was calculated based on actual measurements from test. - Lipid content:
- 6.7 %
- Time point:
- other: on Day 8
- Remarks on result:
- other: for Test 1
- Lipid content:
- 7.8 %
- Time point:
- other: on Day 8
- Remarks on result:
- other: for Test 2
- Key result
- Type:
- BCF
- Value:
- 1 200 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 16 d
- Calculation basis:
- steady state
- Remarks on result:
- other: BCF determined by curves fitted by eye
- Remarks:
- Conc.in environment / dose:4.8 ug/L
- Key result
- Type:
- BCF
- Value:
- 1 300 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 16 d
- Calculation basis:
- steady state
- Remarks on result:
- other: BCF determined by curves fitted by eye
- Remarks:
- Conc.in environment / dose:4.9 ug/L
- Elimination:
- yes
- Parameter:
- other:
- Depuration time (DT):
- 32 d
- Remarks on result:
- not measured/tested
- Details on kinetic parameters:
- - Uptake rate constant (k1):not provided
- Depuration (loss) rate constant (k2):not provided - Metabolites:
- not provided
- Results with reference substance (positive control):
- NA
- Details on results:
- Study does not give test organism survival.
- Reported statistics:
- BCF determinations were made by graphing results and fitting by eye.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Study authors conclude provided BCF results for three saltwater organisms which are 5 to 340 times higher than other reported values. Mean BCF for Gasterosteus aculeatus based on whole body tissue wet weight caluclated at 1200 for Test 1 and 1300 for Test 2.
- Executive summary:
The 16-day chronic toxicity and bioconcentration of nonylphenol to Gasterosteus aculeatus was studied under flow-through conditions in a laboratory. Fish were exposed to average measured concentration of 4.8 and 4.9 ug 14C-labeled nonylphenol/L for 16 days. Fish whole body tissue and water column concentrations were measured at days 2, 4, 8, 16, 18, 20, 24, 32, and 48 (from the start of the exposure, including depuration) for mean BCF
determination. Steady state was reached after a few days, but by Day 16. Depuration stage was for 32 days.
This study is classified as acceptable and satisfies the guideline requirements for a bioconcentration test with Gasterosteus aculeatus.
Results Synopsis
Mean BCF based on whole body tissue wet weight = 1200 for Test 1 and 1300 for Test 2. The results have been lipid normalised based on the lipid values provided in the report, with calculated BCFs of 833 to 896. Results of this study show the BCF of valid fish bioconcentration studies are lower than the REACH bioaccumulation criterion of < 2,000. The BCF value of 896 is used for the purposes of risk assessment for nonylphenol.
Reference
Description of key information
A weight of evidence approach has been taken to the determination of the potential for nonylphenol to bioaccumulate in aquatic organisms and is described in a separate technical report in Section 13 of the CSA.
For the purposes of the risk assessment, the BCF from the Ekelund et al (1990) study with the fish Gasterosteus aculeatus is used. Based on whole body tissue wet weight the BCF is 1200 for Test 1 and 1300 for Test 2. The results have been lipid normalised based on the lipid values provided in the report, with calculated BCFs of 833 to 896. The highest value of 896 and most conservative value is used in the risk assessment. Results of this study show the BCF of valid fish bioconcentration studies are lower than the REACH bioaccumulation criterion of < 2,000.
Key value for chemical safety assessment
- BCF (aquatic species):
- 896 dimensionless
Additional information
Determination of a bioconcentration factor (BCF) follows Guidance on Information Requirements and Chemical Safety Assessment Chapter R.16: Environmental Exposure Estimation (ECHA 2012) and Chapter R. 7c Endpoint Specific Guidance (ECHA 2014). Chapter R.16.5.3.5 states that there may be bioaccumulation potential if log Kow is >3. The log Kow of 4-nonylphenol as given by EU Risk Assessment – 4-Nonylphenol (branched) and Nonylphenol (EURAR, 2002) is 4.48. Therefore, as per REACH Annex IX, bioaccumulation information preferably for fish must be presented for substances manufactured or imported in quantities of 100 t/y or more.
Chapter R.7c states that BCFs can be determined experimentally, by calculation using Kow, or by estimating using BCF models such as QSARs. But, since adequate reliable experimental data are available for the preferred organism (fish) BCFs for 4-nonylphenol are based on actual measured values from experimental tests. Where possible, experimental results have been normalised for a 5% lipid content, as described in the OECD 305 test guideline.
By way of an update and at the request of ECHA a weight of evidence (WoE) approach has been taken to the determination of the potential for nonylphenol to bioaccumulate in aquatic organisms and is described in a separate technical report in Section 13 of the CSA.
The conclusions are that the clear majority of data evaluated in the WoE assessment, particularly after consideration of many confounding factors, pointed towards the hypothesis that nonylphenol is not bioaccumulative. Based on the weighing of all the evidence, it is determined that nonylphenol does not fulfil the bioaccumulation criterion (>2,000) as defined in the PBT criteria in the REACH Regulation and ECHA guidance, in terms of bioaccumulation for fish. To be conservative, a worst case BCF value of 896 for fish (5% lipid normalised), based on Ekelund et al (1990) for stickleback (Gasterosteus aculeatus) is preferred for use in the risk assessment.
The potential for accumulation into other organisms, such as invertebrates, birds and mammals varies and may represent a broader range of concentrations factors than for fish species. The weight of this evidence does not generally indicate bioaccumulation or biomagnification for these species. It might be postulated that some very worst-case scenarios may occur for filter feeders, such as bivalves under certain unknown circumstances.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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