4,4'-isopropylidenediphenol

Ecotoxicological Summary

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: NOEC ≤ 0.01 mg/L   category 2:  0.1 mg/L ≤ NOEC ≥ 0.01 mg/L
Crustacea	Americamysis bahia		Lee (2010), published in Mihaich et al. (2018). EPA OPPTS 850.1350	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