Reaction mass of sodium hydrogen N,N-dibutyl-10-(sulphonatooxy)octadecanamidate and sodium sulphooctadecanoate

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.2 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.046 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.02 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

0.46 mg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1 000 mg/L

Assessment factor:

1

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

8.23 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.823 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:

4.74 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

The PNEC derivation was justified as follows:

All ecotoxicological studies relevant for the Environmental Risk Assessment were performed with a commercial formulation containing 46.2% (w/w) of the REACH registration substance. The water content of the actual test item was 57.6% (w/w). For the substance subject to REACH registration a water content of 3.8% (w/w) was analytically determined (please refer IUCLID section 1.2). Thus, for the sake of completeness, effect concentrations obtained for the actual test item were recalculated to determine effect concentrations that correspond to the REACH registration substance taking into account its specific water content (please refer to section "Conclusion on classification" below).

However, PNEC values were derived on the effect concentrations determined for the commercial formulation which were not correced for the higher water content in comparison to the REACH registration substance. This has been done since in the risk assessment the manufactured and used tonnages of the commercial formulation were used for expoure assessment (instead of the adaptation of the tonnages to the REACH registration substance with a lower water content).

PNEC freshwater sediment

K_(susp-water) = 10.29

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

= (K_(susp-water)/ RHO_(susp)) * PNEC_freshwater * 1000

= (10.29/1150) * 0.2 * 1000

= 0.1789 mg/kg wwt

= 8.23 mg/kg dw

PNEC marine water sediment

K_(susp-water) = 10.29

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marinewater sediment

= (K_(susp-water)/ RHO_(susp)) * PNEC_marinewater * 1000

= (10.29/1150) * 0.02 * 1000

= 0.01789 mg/kg wwt

= 0.823 mg/kg dw

PNECsoil

K_(soil-water) = 35.67

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

= (K_(soil-water)/ RHO_(soil)) * PNEC_freshwater * 1000

= (35.67/1700) * 0.2 * 1000

= 4.196 mg/kg wwt

= 4.74 mg/kg dw

Conclusion on classification

All aquatic tests were performed with the commercial formulation containing 46.2% (w/w) of the REACH registration substance. The water content of the actual test item was 57.6% (w/w). For the substance subject to REACH registration a water content of 3.8% (w/w) was analytically determined (please refer IUCLID section 1.2). Therefore, results for the actual test item were recalculated to obtain effect concentrations that correspond to the REACH registered substance taking into account its specific water content.

Aquatic acute toxicity

48 h, EC₅₀ (Daphnia magna): 4.58 mg/L (based on nominal concentration of the actual test item; corresponds to 2.12 mg/L of the registration substance)

72 h, ErC₅₀ (Pseudokirchneriella subcapitata): 73 mg/L (based on nominal concentration of the actual test item; corresponds to ca. 33 .73 mg/L of the registration substance)

96 h, LC₅₀ (Brachydanio rerio): 4.72 mg/L (based on nominal concentration of the actual test item; corresponds to ca. 2.18 mg/L of the registration substance)

Aquatic chronic toxicity

21 d, EC₁₀ (Daphnia magna): > 2 mg/L (based on nominal concentration of the actual test item; corresponds to > 0.92 mg/L of the registration substance)

72 h, ErC₁₀ (Pseudokirchneriella subcapitata): 11 mg/L (based on nominal concentration of the actual test item; corresponds to ca. 5.08 mg/L of the registration substance)

8 d, EC₁₀ (Brachydanio rerio): 2.101 mg/L (based on nominal concentration of the actual test item; corresponds to ca. 0.97 mg/L of the registration substance)

Biodegradation: readily biodegradable: 73 % biodegradation after 28 days (based on CO₂evolution test; according to OECD 310 and ISO 14593:1999) and 63 % after 28 days in a supporting study (based on DOC Die-Away-Test according to OECD 301 A and EU method C.4-A).

Partition coefficient: log Pow = 2.99 at 25 °C

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No. 1272/2008. The test substance was found to be readily biodegradable under the test conditions (73 % biodegradation after 28 days; see IUCLID section 5.2.1). Its log Pow was calculated to be 2.99 at 25 °C (see IUCLID section 4.7). Daphnia magna was the most sensitive test species regarding short-term aquatic toxicity with an EC50 of 4.58 mg/L corresponding to 2.12 mg/L of the registration substance. Regarding long-term aquatic toxicity in the test according to OECD TG 212 using Danio rerio signifcant lethal and sublethal effects were identified. The 96 -hour LC₅₀ and 8 -day EC₁₀ for the actual test item was found to be 4.72 mg/L 2.101 mg/L, which corresponds to 2.18 mg/L and 0.97 mg/L for the REACH registration subtance.

Therefore, the registration substance is not classified as short-term (acute) aquatic toxicity but classified as long-term (chronic) aquatic toxicity Category 3 (H412: Harmful to aquatic life with long lasting effects) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fourteenth time in Regulation (EU) 2020/217.