Docosyltrimethylammonium methyl sulphate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

13 µg/L

Assessment factor:

10

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

14 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

1.3 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 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 supporting substance C20/22 ATQ concerning the aquatic compartment, the submission substance is most toxic to daphnia with an acute EC50 (48h) of 1.4 mg/L and a chronic NOEC reproduction (21d) of 130 µg/L.

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

Based on the available data for the terrestrial compartment for the supporting substance C20/22 ATQ, the submission substance 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 thelowest acute value for aquatic species which is the Daphnia EC50 (48h) of 1.4 mg/L, which has been established with the supporting substance C20/22 ATQ (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 mitigation might have taken place reducing the ecotoxicity, a mitigation factor of 10 is applied as a worst case (see CEFIC APAG Aquatic testing approach for Cationic surfactant, REACH Category Approach ‘Primary alkyl amines’). The corrected Daphnia EC50 (48h) to be used for classification is 1.4/10 mg/L = 0.14 mg/L, which leads to R50 for DSD and an M factor of 1 for preparations. Based on these data the conclusion with respect to classification according to Regulation (EC) 1272/2008 (CLP) isAcute Category 1, H400.

As the supporting substance C20/22 ATQ is readily biodegradable (see Section 5.2.1) the same conclusion is drawn for the submission substance and due to the low octanol water partitioning coefficient of 3.01 (see IUCLID section 4.7) bioaccumulation can be neglected. Although the bioconcentration criteria of DSD 67/548/EEC is formally fulfilled (Log Kow >=3) it is scientifically not justified to assign R53 especially as the more modern bioconcentration criteria of the 2^nd ATP to CLP (Commission Regulation (EU) 2011/286) (log Kow >= 4) is not fulfilled and the submission substance is considered readily biodegradable. From a scientific point of view it makes not much sense to classify the submission according 67/548/EEC as a substance with long-term effects and under CLP 2011/286/EU as a substance having an acute (short-term) aquatic hazard, Acute Category 1. This would also confuse the down-stream users of the submission substance.

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 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 2^ndATP of CLP (Commission Regulation (EU) 2011/286) there are different approaches for the environmental classification of long-term effects depending on the number of available chronic ecotoxicity data. As data from three chronic ecotoxicity studies for the supporting substance C20/22 ATQ, and hence also for the submission substance, are available, the classification for long-term effects has to be based on these chronic ecotoxicity data. The lowest chronic data is the NOEC Daphnia ( 21d) of 0.13 mg/L in river water (see Chapter 7.1.1.2.2). Due to potential mitigation of ecotoxicity in river water a mitigation factor of 10 has to be applied resulting in a corrected NOEC Daphnia (21d) of 0.013 mg/L, which results for substances which are rapidly degraded in a Chronic Category 2 Classification.

 

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

 

N, R50 with a M factor of 1 for preparations

Proposed classification according 2^ndATP to CLP (Regulation 2011/286) for long-term effects:

Chronic Category 2, H411

 

OVERALL ENIVIRONMENTAL CLASSIFICATION

Proposed classification according DSD 67/548/EEC for short-term & long-term effects:

N, R50 with a M factor of 1 for preparations

Proposed classification according 2^ndATP to CLP (Regulation 2011/286) for short-term & long-term effects:

Acute Category 1, H400
Chronic Category 2, H411 (no M factor)