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EC number: 201-245-8 | CAS number: 80-05-7
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.023 mg/L
- Assessment factor:
- 2
- Extrapolation method:
- sensitivity distribution
- PNEC freshwater (intermittent releases):
- 0.011 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.019 mg/L
- Assessment factor:
- 2
- Extrapolation method:
- sensitivity distribution
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 320 mg/L
- Assessment factor:
- 1
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 1.2 mg/kg sediment dw
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.24 mg/kg sediment dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 3.7 mg/kg soil dw
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
PNEC freshwater and PNEC marine water:
Both were derived based on a statistical extrapolation method (SSD approach) due to the comprehensive experimental databases including many species and taxonomic groups. An appropriate assessment factor was applied.
PNEC intermittent release, PNEC freshwater sediment, PNEC marine water sediment, PNEC STP and PNEC soil:
Each of these PNEC was derived based on the most sensitive study using experimental data and appropriate assessment factors.
PNEC air was not derived as no hazard was identified.
Conclusion on classification
Summary
Bisphenol A (BPA) has a very robust and comprehensive database of fully reliable (Klimisch 1) toxicity studies relevant for acute and chronic aquatic toxicity classification for the environment. These aquatic toxicity studies include the measurement of apical endpoints related to population relevant effects on survival, growth, development and reproduction. The database contains a diverse set of taxa including several key species of fish, crustacea, and algae/higher plants. Many of these studies have been planned and conducted on the basis of fully validated, internationally acknowledged guidelines (e.g., OECD) and were documented according to GLP requirements. In the exceptional cases where no guidelines were available, test protocols were individually developed on the basis of the most advanced technologies according to the state-of-science and technology. All studies contracted by the BPA producers were performed at fully accredited test institutes of international reputation.
On the basis of this dataset of fully reliable studies and the application of the CLP criteria and the respective guidance document, BPA is to be classified as aquatic chronic, category 2, with no classification for acute aquatic toxicity.
An appropriate application of the CLP criteria and adequate study reliability ratings is further explained below.
Acute aquatic toxicity
For BPA a large set of studies is available on the three trophic levels relevant for acute aquatic toxicity and respective CLP classification, namely 8 fully reliable (Klimisch 1) studies, including (3 studies on fish, 2 on crustacea, 2 on algae, and 1 on aquatic plants), with a range of LC/EC50of 1.1 - 20.0 mg/L), supplemented by many supportive (Klimisch 2) studies.
The lowest acute aquatic toxicity value from fully reliable (Klimisch 1) studies per trophic level is displayed in the table below (the complete list of reliable studies relevant for aquatic acute classification can be found in the document in Chapter 13.2):
Taxa |
Species |
Study / test method |
Acute toxicity value |
CLP criterion |
|
Fish |
Pimephales promelas |
Alexander et al. (1985a)* ASTM E729-80 |
96 h-EC50 |
4.6 mg/L |
LC/EC50 ≤ 1 mg/L |
Crustacea |
Americamysis bahia |
Alexander et al. (1985b)* ASTM E729-80 |
96 h-LC50 |
1.1 mg/L |
|
Algae |
Skeletonema costatum |
Alexander et al (1985c)* EPA 560/6-82-002, EPA 600/9-78-010 |
96 h-EbC50 |
1.1 mg/L |
* All studies published in Alexander et al. (1988).
There is one study by Tato et al. 2018, reporting a LC50of 0.885 mg/L with the crustacean species Acartia clausi. This study clearly deviated from the cited test method, e.g. by using a different species and nauplii instead of adults. Furthermore, there is a lack of transparency in the reporting of tested concentrations and documentation. Hence an appropriate rating of the study should be reliable with restrictions (Klimisch 2). The guidance on the application of the CLP criteria (v5.0, 2017) clearly states repeatedly, that preference should be given to fully reliable (Klimisch 1) studies, whereas Klimisch 2 studies could be used as supportive information.
In conclusion, given the range of fully reliable, high quality (Klimisch 1) studies on acute aquatic toxicity, all of them revealing aquatic toxicity LC/EC50values above the CLP criterion of 1 mg/L, a classification as aquatic acute category 1 is not justified.
Chronic aquatic toxicity
For chronic aquatic toxicity of BPA a large set of studies is available on the three trophic levels relevant for CLP classification, namely 11 fully reliable (Klimisch 1) studies (5 studies on fish, 3 on crustaceans, 2 on algae, and 1 on an aquatic plant) plus 4 further fully reliable studies on other taxa (two on snails, one on rotifers, and one on amphibians); the respective relevant NOECs range from 0.016 to ≥ 0.500 mg/L), supplemented by further supportive (Klimisch 2) studies. The lowest aquatic chronic toxicity value from fully reliable (Klimisch 1) studies per relevant trophic level is displayed in the table below (the complete list of reliable studies can be found in the document in Chapter 13.2):
Taxa |
Species |
Study / test method |
Chronic toxicity value (endpoint) |
CLP criterion |
||
Fish |
Pimephales promelas |
Sumpter et al. (2001), published in Staples et al. (2011). EPA OPP 72-5 |
431 d-NOEC (F2 egg hatchability) |
0.016 mg/L |
For rapidly degradable substances: category 1:
category 2: |
|
Crustacea |
Americamysis bahia |
Lee (2010), published in Mihaich et al. (2018). |
28 d-NOEC (offspring reproduction) |
0.17 mg/L |
||
Algae |
Skeletonema costatum |
Suprenant (1985), published in Alexander et al. (1988). EPA 560/6-82-002 |
96 h-EbC10 (biomass) |
0.4 mg/L |
||
Supportive SSD approach |
||||||
SSD |
- |
- |
HC5 |
0.0136 mg/L |
||
|
||||||
Other taxonomic groups not directly relevant for CLP |
|
|||||
Molluscs |
Marisa cornuarietis |
Warbritton (2007), published in Forbes et al. (2008) |
328 d-NOEC (juvenile growth) |
0.025 mg/L |
||
Amphibia |
Xenopus laevis |
Pickford (2000), published in Pickford (2003) |
90 d-NOEC (larval growth, development and sexual differentiation) |
≥ 0.50 mg/L |
||
Based on the lowest NOECs of fully reliable studies, a chronic classification in category 2 is justified, as all values are within the NOEC range of this category.
As stated above, there are five chronic studies on fish with an adequate rating as fully reliable (Klimisch 1). The lowest NOEC of these studies is 0.016 mg/L. It was determined forPimephales promelasin a study using GLP documentation following a test method similar to EPA OPP 72-5. The NOEC isbased on the endpoint F2 egg hatchability (Sumpter et al., 2001, published in Staples et al. 2011).
For crustacea, which according to CLP Regulation should be used for classification, the lowest NOEC is 0.17 mg/L derived from a fully reliable (Klimisch 1) study onAmericamysis bahia,according to test method EPA OPPTS 850.1350, using GLP documentation (Lee, 2010, published in Mihaich et al. 2018).
For algae, there are no NOECs reported below thresholds relevant for classification. Hence studies on algae are not further discussed.
For BPA there is a huge number of reliable data (Klimisch 1 and 2) among the taxonomic groups which are relevant for the CLP classification, as well as for other taxa. This data may be used in a probabilistic approach to support the deterministic CLP classification. The respective SSD-calculation based on this dataset results in normally distributed NOECs and calculates an HC5 value from all NOECs as 0.0136 mg/L (See document in Chapter 13.2). This HC5 value is well above 0.01 mg/L and thus supports the deterministically derived lowest NOEC and the respective classification as aquatic chronic category 2.
Based on the lowest NOECs from fully reliable studies covering the three trophic levels which are relevant under CLP (algae, crustacea, and fish), a classification as aquatic chronic category 2 is appropriate, as there is no valid NOEC lower than or equal to the threshold of 0.01 mg/L for category 1. This is supported even for other taxa based on fully reliable (Klimisch 1 studies). Also a probabilistic approach based on a set of reliable studies covering a broad range of different taxa and species results in a HC5 value above the threshold of 0.01 mg/L.
Final Conclusion
Based on the fully reliable and relevant acute and chronic aquatic toxicity data and in accordance with the criteria of the CLP Regulation BPA should be classified as:
a) Acute aquatic toxicity: no classification
b) Chronic aquatic toxicity: category 2
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