Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.016 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.34 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1.5 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
9 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.8 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:
0.031 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
222.22 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

Based on all the available ecotoxicological data for invertebrates, fish and algae, TBBPA should be classified and labelled as N; R50/53 in accordance with Directive 67/548/EEC and as Aquatic Acute Category 1 and Aquatic Chronic Category 1 in accordance with Regulation (EC) No. 1272/2008.

The key values used for chemical safety assessment were as follows:

- Short term toxicity to fish: LC50 = 1.1 mg/L (Oncorhynchus mykiss)

- Long term toxicity to fish: NOEC = 0.16 mg/L (Pimephales promelas)

- Short term toxicity to invertebrates: LC50 >1.8 mg/L (Daphnia magna)

- Long term toxicity to invertebrates: freshwater NOEC = 0.38 mg/L (Daphnia magna); marine water NOEC = 0.017 mg/L (Mytilus edulis)

- Toxicity to algae: NOEC = 5.6 mg/L (Pseudokirchneriella subcapitata)

- The substance is not readily biodegradable

- The log Kow is 5.9 at 25 °C

Furthermore, TBBPA is officially classified as N; R50/53 on Annex I of Directive 67/548/EEC and as Aquatic Acute Category 1 and Aquatic Chronic Category 1 on Annex VI of Regulation (EC) No. 1272/2008.