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EC number: 201-245-8
CAS number: 80-05-7
Bisphenol A; BPA
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.
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
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.
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