Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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):
0.588 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:
1.141 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

According to Article 13 of Regulation (EC) No 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", Information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”. Since the read-across concept is applied for selected endpoint, data will be generated from a representative source substance to avoid unnecessary animal testing. Additionally, once the read-across concept is applied, substances will be classified and labelled on this basis.

Brief description of the data relevant for classification

Degradation

Biodegradation: Readily biodegradable: 61% after 28 d (ISO 14593:1999)

Bioaccumulation

Expert statement: BCF 12.6 - 14.6 L/kg (BCFBAF v3.01)

Aquatic acute toxicity

For fish: 96 h, LC50 (Danio rerio): LL50 (96 h) > 100 mg/L (OECD 203); read-across

For aquatic invertebrates: 48 h, LL50 (Acartia tonsa): > 10000 mg/L (PARCOM, 1999); read-across

For algae/aquatic plants: 72 h, ErL50 (Pseudokirchneriella subcapitata): 58.84 mg/L (OECD 201); read-across

Aquatic chronic toxicity

For fish: no data available

For aquatic invertebrates: 21 d, NOELR (Daphnia magna): 10 mg/L (OECD 211); read-across

For algae/aquatic plants: 72 h, ErL10 (Pseudokirchneriella subcapitata): 19.05 mg/L (OECD 201); read-across

Conclusion on classification

CLP:

Based on the data above,sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated)(CAS 9005-65-6) is considered to be rapidly degradable. The acute aquatic toxicity L(E) C50 values are > 10 mg/L. Therefore,sorbitan monooleate, ethoxylated (1-6.5 moles 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 NOELR/EC10 values are > 1 mg/L. Therefore, sorbitan monooleate, ethoxylated (1-6.5 moles 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 monooleate, ethoxylated (1-6.5 moles ethoxylated) (CAS 9005-65-6) is considered to be rapidly degradable and has low potential for bioaccumulation. The acute aquatic toxicity L(E) C50 values are > 10 mg/L for fish, invertebrates and algae. Therefore,sorbitan monooleate, ethoxylated (1-6.5 moles ethoxylated)does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.