Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.32 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.032 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

Justification for classification

According to Article 13 "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 substance. This avoids the need to test every substance for every endpoint”.

Since the group concept is applied to the members of the Sorbitan esters category, data will be generated from representative category members to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.

Brief description of the data relevant for classification

Degradation

Biodegradation:                    88% of O2 consumption (OECD 301 C); read-across

Bioaccumulation

Expert statement:               Bioaccumulation is expected to be low.

Aquatic acute toxicity

For fish:                                   96 h, LC50 (Oryzias latipes): no effects up to the limit of water solubility; read-across

For aquatic invertebrates: 48 h, EC50 (Daphnia magna): no effects up to the limit of water solubility; read-across

For algae/aquatic plants:  72 h, ErC50 (Pseudokirchneriella subcapitata): No effects up to a loading rate of 100 mg/L; read-across

Aquatic chronic toxicity

For fish:                                   no data available

For aquatic invertebrates:        21 d, NOEC (Daphnia magna): no effects up to the limit of water solubility; read-across

For algae/aquatic plant:    72 h, NOErC (Pseudokirchneriella subcapitata): No effects up to a loading rate of 100 mg/L; read-across

 

Conclusion on classification

CLP:

Based on the data above, Sorbitan tristearate is considered to be rapidly degradable. The acute aquatic toxicity L(E)C50 values are > 1 mg/L or no effects occurred up to the limit of water solubility limit for fish, invertebrates and algae. Therefore, Sorbitan tristearate 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 or no effects occurred up to the limit of water solubility limit for fish, invertebrates and algae. Therefore, Sorbitan tristearate 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:

The acute aquatic toxicity L(E)C50 values are > 100 mg/L or no effects occurred up to the limit of water solubility limit for fish, invertebrates and algae. Therefore, Sorbitan tristearate does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.