Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
12 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
9 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.2 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.25 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
125 µg/kg sediment dw
Assessment factor:
500
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:
1 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
6.7 mg/kg food
Assessment factor:
30

Additional information

Based on the available data for the aquatic compartment C20/22 ATQ is most toxic to daphnia with an acute EC50 (48h) of 1.4 mg/L and a chronic NOEC reproduction (21d) of 119 µg/L.

Based on the available data for the freshwater sediment compartment C20/22 ATQ is most toxic to the endobenthic worm Lumbriculus variegatus with an NOEC reproduction (28d) of 62.5 mg/kg dw.

Based on the available data for the terrestrial compartment C20/22 ATQ is most toxic to soil microorganisms with a NOEC of 10 mg/kg soil dw.

Conclusion on classification

 

Short-term effects

The Environmental classification has to take into account the lowest acute value for aquatic species which is the Daphnia EC50 (48h) of 1.4 mg/L (see Section 6.1.5). This study was carried out in river water to ensure a reliable testing of the cationic surfactant C20/22 ATQ. As a mitigation might have taken place reducing the ecotoxicity, a Mitigation factor of 10 has be applied as a worst case (see CEFIC APAG Aquatic testing approach for Cationic surfactant, REACH Category Approach ‘Primary alkyl amines’). The corrected EC50 (48h) Daphnia to be used in Classification is 1.4/10 mg/L = 0.14 mg/L which leads to R50 for DSD and a M factor of 1 for preparations.

In addition C20/22 ATQ is readily biodegradable, but failed 10-day windows (see Section 5.2.1) and due to the low octanol water partitioning coefficient of 3.3 (see Section 4.7) bioaccumulation can be neglected. The criteria of CLP2011/286/EU(log Kow >= 4) is not fulfilled.

Based on these facts an environmental classification should be based on the ecotoxicity only as the criteria for long-term effects are not fulfilled.

Proposed classification according DSD 67/548/EEC for Short-term effects:

N, R50 with a M factor of 1 for preparations

Proposed classification according CLP 2011/286/EUfor Short-term effects

Acute Category 1, H400

 

Long-term (chronic) effects

According to the 2ndATP of CLP (286/2011/EU) there are different approaches for the environmental classification of Long-term effects depending on the number of available chronic ecotoxicity data. As three chronic ecotoxicity data for C20/22 ATQ are available the classification for long-term effects has to be based on the chronic ecotoxicity data. The lowest chronic data is the NOEC Daphnia( 21d) 0.119 mg/L in river water (see Chapter 7.1.1.2.2). Due to potential mitigation of ecotoxicity in river water an Application factor of 10 has to be applied resulting in a NOEC Daphnia (21d) of 0.012 mg/L which results for this substances in a Chronic Category 1 Classification.

In Summary

Proposed classification according CLP2011/286/EU for Long-term effects:

Chronic Category 2, H410

OVERALL ENIVIRONMENTAL CLASSIFICATION

Proposed classification according CLP 2011/286/EU for Short-term & Long-term effects:

Acute Category 1, H400 Chronic Category 1, H410 (no M factor)