Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.018 mg/L
Assessment factor:
1
Extrapolation method:
sensitivity distribution
PNEC freshwater (intermittent releases):
0.011 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.018 mg/L
Assessment factor:
1
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

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.