Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.007 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.058 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.006 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.011 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

The PNEC for secondary poisoning should be considered as preliminary pending the definitive outcome of the combined repeated dose toxicity study / reproduction-developmental toxicity screening test. When the substance is subject to classification, a PNEC for secondary poisoning must be derived.

Conclusion on classification

For TMBPA aquatic toxicity data are available for three trophic levels (fish, invertebrates and alga). The lowest acute and chronic toxicity values are a 72-h ErC50 of 0.67 mg/L and a 72-h NOErC of 0.15 mg/L in freshwater alga (P. subcapitata). In addition TMBPA is not readily biodegradable. Based on these data the substance needs to be classified as Acute Toxicity Category 1, H400 (very toxic to aquatic life) and Chronic Toxicity Category 1, H410 (very toxic to aquatic life with long lasting effects) according to the CLP Regulations (EC) No 1272/2008. According to the Dangerous Substance Directive 67/548/EC, the available ecotoxicological information warrants classification as N; R50/53 (very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment).