Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-245-8 | CAS number: 80-05-7 Bisphenol A; BPA
Toxicity to other aquatic organisms
Administrative data
Link to relevant study record(s)
Description of key information
There is one key study for Bisphenol A which was evaluated to be Klimisch 1, reliable without restriction (Pickford et al., 2000; published as Pickford et al., 2003). In this non-guideline study which lasted 90 days, the NOEC for Xenopus laevis based on larval survival, adult growth and sex ratio was determined to be 500 µg/L, the highest dose of Bisphenol A tested. It shall specifically be mentioned that there was no impact on the frog sex ratio at all treatment concentrations or negative control, while in the positive control group a significant feminisation was observed. Thus, the NOEC for all endpoints was determined to be ≥ 500 µg/L.
Additional information
African clawed frog (Xenopus laevis) larvae at a developmental stage between 43 and 45, were exposed to nominal Bisphenol A concentrations of 0, 1.0, 2.3, 10, 23, 100, and 500 µg/L, in flow-through conditions until they reached complete metamorphosis (Pickford et al., 2000; published as Pickford et al., 2003). Results are reported based on nominal concentrations. After 90 days, larvae were sacrificed, and total length, snout-vent length and wet weight were measured. Sexual differentiation in larvae at developmental stages 58-66 was evaluated by inspection of gross gonadal morphology. The NOEC for survival, sex ratio, length and weight was determined to be 500 µg/L. There was no significant difference in mean percentage survival between Bisphenol A, positive control (17ß-estradiol), and dilution water control but there was a significantly lower survival rate at 500 µg/L than at 100 µg/L of Bisphenol A. Compared to the dilution control, there was no significant difference between growth, development, and time to metamorphosis in the Bisphenol A treatment groups while there was a significant difference in the positive control with regards to mean time to metamorphosis. There was also a significant increase in total length, snout-length, and wet weight in males between positive control and the dilution control but no noticeable difference in Bisphenol A froglets. Thus, the NOEC for all endpoints was determined to be ≥ 500 mg/L.
A further study with Xenopus laevis was identified (Levy et al., 2004). This study was disregarded due to major short-comings (Klimisch 3, not reliable) such as insufficient replication and erroneous statistical evaluation. Details on the short-comings are provided in the executive robust study summary.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
