Registration Dossier
Registration Dossier
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EC number: 202-653-9 | CAS number: 98-29-3
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 1.2 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1.2 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.12 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 0.16 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 6.9 µg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.69 µg/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:
- 0.68 µg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
The new study performed according to OECD guidelines 211 leads to an increase of the PNEC for aquatic freshwater compartment by a factor of 10. It impacts in the same manner the PNECs for the sediment and soil compartments.
Conclusion on classification
Based on acute toxicity tests on fish, invertebrates and algae, 4-TBC appears to be very toxic to the aquatic organisms; with reliable L/EC50 values ranging from 0.1 to 1 mg/L. In addition, the results of ready biodegradation study shows that 4-TBC is not readily biodegradable. As a consequence, 4-TBC is classified regarding its environmental impacts Aquatic Acute Cat. 1 (H400) with M factor = 1 under Regulation (EC) No 1272/2008.
A chronic Daphnia magna study is also available which resulted in a NOEC (21-days) of 0.135 mg/L. Based on this chronic data and the conclusion that 4-TBC is not readily biodegradable, the substance warrants classification as Aquatic Chronic Category 2 (H411) under Regulation No. 1272/2008 (Annex 1 of CLP Regulation, Table 4.1.1) (i). However, as no chronic data is available for fish, figure 4.1.1 requires that the available acute toxicity data for fish is compared with the criteria in table 4.1.0 (b) (iii). As 4-TBC is not readily biodegradable and has an LC50 (fish) is lower than 1 mg/L, classification as Aquatic Chronic Cat. 1 is warranted. As chronic Cat. 1 is the outcome, comparing the data with the acute toxicity criteria of table 4.1.3 results in an M-factor of 1. As this surrogate approach indicates a more stringent classification outcome than that derived by using chronic data, this more stringent outcome is used for classification.
In conclusion, 4-TBC appears to warrant classification as Aquatic Acute Cat. 1 (H400), M = 1 and Aquatic Chronic Cat. 1 (H410), M = 1.
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