Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
13.4 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.2 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
6.32 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:
12.6 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Available toxicity information relevant for risk assessment (PNEC) purposes:

 

Acute toxicity info:

-  Fish: There are different tests available which overall indicate that there is no toxicity below water solubility levels: LC50 (96h) typically > 1000 mg/L (different tests).

- Invertebrates: There are different acute tests on different species available. Based on these results there is no toxicity below water solubility levels. The most trustworthy result was determined for Daphnia magna: EC50 (48h) > 1.34 mg/L.

- Algae: There are 2 tests available. The key study was performed on a WAF solution and no toxicity was observed in the highest loading (100 mg/L).

 

Conclusion acute toxicity results:

There is no toxicity below water solubility levels and invertebrates (Daphnia) are most sensitive organisms.

 

Chronic toxicity info:

- Fish: No chronic fish tests available on the hydrogenated terphenyls.

- Invertebrates: A new 21-day daphnia tests was performed using a WAF approach. The NOELR for reproduction is < 1 mg/L, the NOELR for mortality = 1 mg/L after 21 days. Suggested interpretation of the results: NOELR > 0.1 mg/L but < 1 mg/L.

- Algae: There are 2 tests available. The key study was performed on a WAF solution and no toxicity was observed in the highest loading (100 mg/L).

 

Conclusion chronic toxicity results:

There is a long-term toxicity test available on the most sensitive species available (Daphnia). The NOELR is for reproduction is assumed to be > 0.1 and < 1 mg/L.

 

Determination of the starting point for the PNEC derivation:

 

·      Available data:

o  Acute: 3 trophic levels

o  Chronic: 2 trophic levels, most sensitive level being covered

·      Lowest toxicity result: long-term daphnia (21d) NOELR > 0.1 mg/L < 0.1 mg/L. Therefore, 0.1 mg/L is used as start value.

Conclusion on classification

Currently, the acute aquatic toxicity data indicate that there is no toxicity up to water solubility levels. The chronic toxicity data indicate that the chronic NOELR is > 0.1 mg/L (based on a long-term Daphnia magna study). In addition, the substance should be considered as not readily biodegradable and there is potential for bioaccumulation.

CLP classification (EC No 1272/2008), amendment No286/2011

Based on the fact that the substance is not acutely toxic up to water solubility levels, no classification for acute toxicity is warranted. With regard to the long-term aquatic hazard, as the substance is not considered as readily biodegradable and the Daphnia magna NOELR (21d, reproduction)is > 0.1 but < 1 mg/L, classification for Aquatic Toxicity Category Chronic 2. Based on this NOELR, no M-factor is required.