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EC number: 904-653-0 | CAS number: -
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol can be predicted by studies conducted with the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol, because the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol contains phenol (40-45%, typical concentration ca. 40%) and 4,4’-isopropylidenediphenol (BPA) (20-40%, typical concentration ca. 33%) as main constituents. Both constituents are data rich substances with distinct hazard properties, so that mainly data on the constituents have been applied to characterize the Reaction mass of phenol and 4,4’-isopropylidenediphenol. Since this is a common approach in mixture hazard assessment, is reasonable to apply it also to multi-constituent substances.
Additionally, some data from a structurally related substance (2-acetone, polymer with phenol) containing the same constituents/impurities at different concentrations are available, which are applied to characterize the environmental fate and ecotoxicity of the impurities present in the Reaction mass of phenol and 4,4’-isopropylidenediphenol.
This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol are predicted to be similar to those of the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol.
Therefore, read-across from the available studies with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
please refer to justification for read-across attached to Iuclid section 13
3. ANALOGUE APPROACH JUSTIFICATION
please refer to justification for read-across attached to Iuclid section 13
4. DATA MATRIX
please refer to justification for read-across attached to Iuclid section 13 - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 10.2 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: BPA
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.1 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: phenol
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 8.27 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 2-Acetone, polymer with phenol
- Conclusions:
- The lowest effect level obtained in freshwater organisms for BPA was the 48 h EC50 of 10.2 mg/L in Daphnia magna; for marine organisms (Mysidopsis bahia) the 96 h EC50 was 1.1 mg/L.
The EC50 for phenol was 3.1 mg/L.
Due to the physicochemical properties of phenol, this major constituent of the reaction mass is capable of targeting aquatic and terrestrial wildlife through a different exposure route than 4,4’-isopropylidenediphenol. Therefore, to adequately characterize the hazard of the reaction mass toward ecotoxicology endpoints, the toxicity and fate of both major constituents of the reaction mass of phenol and 4,4’-isopropylidenediphenol were considered and two sets of PNECs (one for phenol one for 4,4’-isopropylidenediphenol) were derived and an assessment entity approach was applied.
Reference
Description of key information
When a freshwater invertebrate species, Ceriodaphnia dubia, was exposed to phenol, a major component of the reaction mass of phenol and 4,4’-isopropylidenediphenol (referred to henceforth as “the reaction mass”), the 48-hour EC50 value was 3.1 mg/L. When a saltwater species, the mysid shrimp (Americamysis bahia), was exposed to Bisphenol A (a.k.a. 4,4’-isopropylidenediphenol, which is the other major component of the reaction mass), the 96-hour EC50 value was 1.1 mg/L. These results were selected as key studies, since they were from valid toxicity tests that reported the lowest EC50 values for these parameters.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Remarks:
- Phenol
- Effect concentration:
- 3.1 mg/L
Fresh water invertebrates
- Dose descriptor:
- EC50
- Remarks:
- BPA
- Effect concentration:
- 10.2 mg/L
Marine water invertebrates
Marine water invertebrates
- Dose descriptor:
- EC50
- Remarks:
- BPA
- Effect concentration:
- 1.1 mg/L
Additional information
No experimental data are available for the target substance reaction mass of phenol and 4,4’-isopropylidenediphenol. The toxicity to invetebrates was assessed by examination of the properties of the constituents and impurities of the multi-constituent substance. A justification for read-across is attached to Iuclid section 13.
Studies with Bisphenol A
A 96-hr acute flow-through mysid (Mysidopsis bahia) study was performed with nominal concentrations of 0, 0.89, 1.4, 2.1, 3.2, and 5.0 mg/L. These corresponded to measured concentrations of 0, 0.51, 0.86, 1.4, 1.9, and 3.3, respectively. The 24-, 48-, 72-, and 96-hour LC50's (95% confidence intervals) were calculated to be 3.3 (2.6-5.7), 1.6 (1.3-1.9), 1.2 (1.0-1.3), and 1.1 (0.92-1.2) mg/l, respectively. One mortality occurred in the control over the course of the study. The no discernable effect concentration in this study was found to be 0.51 mg/L. This concentration produced only one mortality among the 20 exposed mysids during the 96-hour study period.
A 48-hr Daphnia magna acute study under static conditions was performed. Daphnia were exposed to nominal concentrations ranging from 0.93 to 20.0 mg/L and a control. These nominal concentrations corresponded to measured concentrations ranging from 0.90 to 19.34 mg/L. The 24-hr and 48-hr EC50 values (and 95% confidence intervals) were 16 (14 -17) and 10.2 (9.2 -11) mg/L Bisphenol A, respectively.
Studies with Phenol
In a 48-h acute toxicity study Ceriodaphnia dubia (< 12 h old neonates at test start) was exposed to phenol at measured concentrations up to 6 mg/L (measured at test start, four concentrations and 1 control, 6, 4, 2, 1 mg/L, details of measured concentrations and recovery of nominal levels not reported) under static conditions at 25°C.
The EC50 was calculated to be 3.1 mg/L (95% C.I.:not calculated).
Studies with 2-Acetone, polymer with phenol
A study was performed to assess the acute toxicity of Bisphenolharz spezial to Daphnia magna STRAUS under static conditions.
The study was conducted in accordance with the Council Regulation (EC) No 440/2008, Method C.2 ‘Acute toxicity for Daphnia’ (2008) which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilisation Test' (adopted April 13, 2004).
The Daphnia were exposed to a range of concentrations, nominally 2.5, 5, 10, 20 and 40 mg/L of Bisphenolharz spezial dissolved in water. Auxiliaries used to prepare the test media were a mortar an ultrasonic bath, a magnetic stirrer and folded filters.
Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. The 48 h EC50 was determined to be 8.27 mg/L.
The results are expressed in terms of initial concentrations. Effective concentrations ranged from 36.7 – 75.2% of nominal values at 0 hours, and from 51.6 – 73.6% of nominal values at 48 hours, respectively. Based on initial concentrations measured concentrations ranged from 94.3 – 99.1% of initial values after 24, 48 hours of exposure respectively.
Conclusion
The lowest effect level obtained in freshwater organisms for BPA was the 48 h EC50 of 10.2 mg/L in Daphnia magna; for marine organisms (Mysidopsis bahia) the 96 h EC50 was 1.1 mg/L.
The EC50 for phenol was 3.1 mg/L.
Due to the physicochemical properties of phenol, this major constituent of the reaction mass is capable of targeting aquatic and terrestrial wildlife through a different exposure route than 4,4’-isopropylidenediphenol. Therefore, to adequately characterize the hazard of the reaction mass toward ecotoxicology endpoints, the toxicity and fate of both major constituents of the reaction mass of phenol and 4,4’-isopropylidenediphenol were considered and two sets of PNECs (one for phenol one for 4,4’-isopropylidenediphenol) were derived and an assessment entity approach was applied.
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