Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3 860 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
92.8 mg/kg sediment dw

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
3 132 mg/kg soil dw

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

Conclusion on classification

According to the CLP Regulation (EC 1272/2008), acute aquatic toxicity is normally determined using a fish 96-hour LC50, a crustacean species 48-hour EC50 and/or an algal species 72- or 96-hour EC50; nevertheless it is also specified in the Regulation that data on other species (e. g. Lemna spp.) shall also be considered if the test methodology is suitable. These species cover a range of trophic levels and are considered as surrogate for all aquatic organisms.

According to the table 4.1.0 of the CLP Regulation (EC n. 1272/2008), a substance for wich adequate chronic toxicity data are not available shall be classified as

Aquatic Acute 1 when:

96 hr LC50 (for fish)≤1 mg/l and/or

48 hr EC50 (for crustacea)≤1mg/l and/or

72 or 96 hr ErC (for algae or other aquatic plants)≤1 mg/l

  Aquatic Chronic 1 when:

96 hr LC50 (for fish)≤1 mg/l and/or

48 hr EC50 (for crustacea)≤1mg/l and/or

72 or 96 hr ErC (for algae or other aquatic plants)≤1 mg/l 

 

Aquatic Chronic 2 when:

96 hr LC50 (for fish) > 1 <= 10 mg/l and/or

48 hr EC50 (for crustacea)> 1 <= 10 mg/l and/or

72 or 96 hr ErC (for algae or other aquatic plants)> 1 <= 10 mg/l 

Aquatic Chronic 3 when:

96 hr LC50 (for fish) > 10 <= 100 mg/l and/or

48 hr EC50 (for crustacea)> 10 <= 100 mg/l and/or

72 or 96 hr ErC (for algae or other aquatic plants)> 10 <= 100 mg/l

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4)

The analogue substance is considered inherently biodegradable and has LC50 for each trophic levels > 100 mg/l, therefore it is not classified for both acute and chronic aquatic toxicity. Based on the read across considerations same results apply to Stearamide DETA.

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