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Long-term toxicity to aquatic invertebrates

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Description of key information

There are four key studies available which are reliable without restriction (Klimisch 1) and which address the long-term toxicity of Bisphenol A to aquatic invertebrates. These include three studies on freshwater species: a Daphnia magna reproduction study according to OECD 211 revealing a NOEC of 3.16 mg/L (Caspers, 1998), a rotifer life-cycle study which followed the ASTM Guideline E1440-91 and report a NOEC of 1.8 mg/L (Springborn Smithers, 2006a; publishes in Mihaich et al., 2009), and a 328-d reproduction study with Marisa cornuarietis snail with a NOEC of 0.025 mg/L (Warbritton et al., 2007a; published as Forbes et al. 2008). For this latter study with M. cornuarietis there was no guideline available at this point in time. However, this study was conducted as a follow up of the Oehlmann et al., 2006, study with M. cornuarietis which had severe short-comings. The test setup of Warbritton et al., 2007a, in contrast was coordinated with the rapporteur UK of the European Risk Assessment (2003, 2008, 2010) and was performed in accordance with state of science and technology.

For marine water species, there is one key study, namely a life-cycle study according to EPA OPPTS 850.1350 test method with Americamysis bahia which determined a NOEC of 0.17 mg/L (Lee, 2010; published in Mihaich et al. 2018).

Thus, in freshwater the key study Warbritton et al., 2007a, which report a NOEC of 0.025 mg/L and for marine water the study of Lee, 2010, with the NOEC of 0.17 mg/L report of the lowest effect level.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
0.025 mg/L
EC10, LC10 or NOEC for marine water invertebrates:
0.17 mg/L

Additional information

Caspers (1998) conducted a chronic Daphnia magna reproduction study (OECD 211) including the assessment on molting of the water flea. Test concentrations were 0, 0.316, and 3.16 mg/L BPA.  There was no effect on reproduction or molting behavior and the NOEC was thus equal to the highest test concentration of 3.16 mg/L.

Another key study for assessing the long-term toxicity of Bisphenol A to aquatic invertebrates is a life-cycle rotifer study with Bisphenol A (Springborn Smithers, 2006a; publishes in Mihaich et al., 2009). The purpose of this study was to determine the chronic toxicity of Bisphenol A to the rotifer Brachionus calyciflorus under static test conditions. Based on mean measured concentrations the NOEC for reproduction (intrinsic rate of increase) was determined to be 1.8 mg/L.

Warbritton et al. (2007a) conducted a 328-d study exposing snails (Marisa cornuarietis) to 0, 0.1, 1.0, 25, and 640 μg/L BPA under flow-through conditions. This study aimed to evaluate effects on mortality, fecundity, hatchability, and juvenile growth. There was no effect on fecundity or hatchability and for both endpoints a NOEC of > 640 µg/L was reported. For juvenile growth the NOEC was reported to be 25 µg/L.

In a 28-day life cycle study with the estuarine mysid shrimp (Americamysis bahia) (Lee, 2010; published in Mihaich et al. 2018), endpoints of F0 survival, growth (mean dry body weight and mean total body length) of both male and female mysids and reproduction (number of young released per female) were assessed. Test concentrations were 38, 75, 150, 300 and 600 µg/L BPA but effects were reported based on time-weighted average concentrations (18, 41, 74, 170 and 370 µg/L). Reproduction was the most sensitive endpoint with a NOEC of 170 µg/L BPA. The 28 d-LC50 was reported > 370 µg/L as the mortality at the highest concentration was below 50 %.

Further studies were identified which were rated as Klimisch 2 or in one case Klimisch 1 (Warbritton, 2007b). The study by Warbritton, 2007b, who investigated effects on M. cornuarietis over 84 days and reported a NOEC of 25 µg/L (equal to Warbritton et al., 2007a). Brennan et al., 2006, conducted a chronic study with D. magna according to ISO 10706 and reported a NOEC of 1 mg/L. Mu et al., 2005b, performed a D. magna reproduction study according to EPA/660/3-75-009 test method and determined a NOEC of 1.5 mg/L. Sieratowicz et al., 2011, a non-guideline study reported a NOEC of 20 µg/L. Finally, Hill et al., 2002, reported a NOEC of 1.6 mg/L in a non-guideline study with the sponges Heteromyenia sp. and Eunapius fragilis.

Thus, there are several studies which support the key studies and which report NOEC in the range of 0.02-1.6 mg/L.

In contrast, several other chronic fish studies which are listed and discussed in this chapter were rated as Klimisch 3 (not reliable) due to major short-comings or Klimisch 4 (not assignable) due to e.g. insufficient documentation and disregarded in the risk assessment. Full justifications for disregard are provided in the endpoint study records and the respective robust study summaries (e.g. Oehlmann et al., 2006, Ladewig et al., 2006, and Schulte-Oehlmann et al., 2001).

Concluding, there are several Klimisch 1 key studies and several Klimisch 1 or 2 supporting studies. The key study Warbritton et al., 2007a, reported the lowest freshwater NOEC of 0.025 mg/L and the key study of Lee, 2010, determined the lowest marine water NOEC of 0.17 mg/L.