Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
4.8 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
48 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
71.4 µg/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:
139.4 µg/kg soil dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

The solubilty problems observed during the acute test are related to the intricate behavior of the substance. The test substance has most likely as for many other surfactants a specific Krafft point/cmc relation which means that at certain temperatures and concentrations cristallinic gels can be formed. Due to this precipitates were formed during the acute test. Most of the acute test were performed at a time when no suitable analytical method was available to quantify the bioavailable concentration and are in general based on nominal test concentrations. The algae study has been read-across from the source chemical Fatty acids, C12 -18 and C18 -unsatd., 2 -sulfoethyl esters, sodium salts (CAS no 85408 -62 -4) to the target chemical coco fatty acids 2 -sulfoethyl sodium salt. Read across is considered to be justified as both substances are very similar and the source chemical contains a higher content of longer alkyl chain products which are known to be more toxic than the shorter alkyl chain products. The conclusion that the source chemical is more toxic than the target chemical is considered sufficient to select the more toxic derivative as the worst-case representative in the hazard assessment of both substances. For this reason read-across of ecotoxicity results of the source chemical (C12-18 and C18-unsatd) to the target chemical (Coco) is considered to be justified without the introduction of an additional safety factor.

Conclusion on classification

Classification according to GHS

Acute (short-term) aquatic hazard

Acute toxicity data for fish, crustacea and algae are > 1 mg/L. Therefore the substance needs no classification with Category Acute 1 and no M-factor needs to be applied.

Long-term aquatic hazard

Except for algae no long-term toxicity data is available. The chronic classification is therefore based on stringent classification of either the available chronic algae endpoint or the acute data and the ready biodegradability and the observed octanol water partition coefficient. With an algae NOEC of 0.3 mg/L the substance needs to be classified as chronic 3 long-term hazardous to the environment. No M-factor needs to be applied.

Safety net classification

The safety net classification does not apply.

Conclusion classification according to GHS

Based on the algae NOEC of 0.3 mg/L a classification as Chronic Cat 3 is applied.

Classification according to 67/548/EEC (DSD)

Acute aquatic toxicity is > 1 mg/L and the substance is rapidly biodegradable. The substance has a low bioaccumulation potential (log Kow of -0.41). Therefore the substance does not need to be classified as toxic to aquatic organisms according to Directive 67/548/EEC.