Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.2 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.239 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.02 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.141 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1 000 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Brief description of the data relevant for classification

Degradation

Biodegradation:                 Readily biodegradable: 62.5% of CO2 evolution (OECD 301 F)

Bioaccumulation

Expert statement:               Bioaccumulation is expected to be low.

Aquatic acute toxicity

For fish:                             96 h, LC50 (Danio rerio): no effects up to the limit of water solubility

For aquatic invertebrates: 21 d, EL50 (Daphnia magna): 23.9 mg/L

For algae/aquatic plants:   72 h, ErL50 (Pseudokirchneriella subcapitata): 58.8 mg/L

Aquatic chronic toxicity

For fish:                              no data available

For aquatic invertebrates:    21 d, NOELR (Daphnia magna): 10 mg/L

For algae/aquatic plant:     72 h, ErL10 (Pseudokirchneriella subcapitata): 19.05 mg/L

Conclusion on classification

CLP:

Based on the data above, Sorbitan monolaurate, ethoxylated is considered to be rapidly degradable. The acute aquatic toxicity L(E)C50 values are > 10 mg/L. Therefore, Sorbitan monolaurate, ethoxylated does not need to be classified and labelled as acute aquatic hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

Valid chronic toxicity data are available for invertebrate and algae - the lowest NOECs are > 1 mg/L. Therefore, Sorbitan monolaurate, ethoxylated does not need to be classified and labelled as long-term aquatic hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

DSD:

Based on the data above, Sorbitan monolaurate, ethoxylated is considered to be rapidly degradable and have low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 values are > 10 mg/L for fish, invertebrates and algae. Therefore, Sorbitan monolaurate, ethoxylated does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.