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EC number: 201-245-8
CAS number: 80-05-7
Bisphenol A; BPA
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
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.
For Bisphenol A (BPA) there is a huge database. Various key and
supporting studies were identified which were usually conducted
according to validated international guideline methods as well as
documented via GLP. Within this database the key studies which reported
of the lowest effect level were chosen for CLP classification of BPA.
The lowest effect level of the key studies was also the lowest effect
level of the supporting studies. Thus, the derived CLP classification is
sufficiently robust and conservative.
The appropriate CLP classification of BPA was determined in
accordance with criteria defined in Regulation (EC) No 1272/2008:
a) Classification for acute aquatic toxicity:
There is only one category for acute toxicity for substances which
cause effects at a test item concentration of ≤ 1mg/L. The study with
the lowest acute toxicity reported of an EC50 of 1.1 mg/L (Alexander et
al., 1985). Thus, Bisphenol A does not fulfil the criterion to be
classified for acute toxicity (i.e. category acute 1).
b) Classification for chronic aquatic toxicity:
Bisphenol A is a rapidly degradable substance for which there are
adequate chronic toxicity data available. The study with the lowest
chronic toxicity reported a NOEC of 0.016 mg/L (Alexander et al., 1985)
which is in the range between 0.01 and 0.1 mg/L. Thus, Bisphenol A
fulfils the criterion to be classified in category chronic 2.
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.
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