Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

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”. Additionally, once the analogue concept is applied, substances will be classified and labelled on this basis.

 

Degradation

Biodegradation: Readily biodegradable: 71.1 - 84.5% after 28 d (OECD 301B); read-across

 

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.

 

Aquatic acute toxicity

No observed toxicological effects up to the limit of water solubility (832 µg/L ± 208 µg/L at 20 °C, pH=6.3)

Fish:

Oryzias latipes LL50 (96 h): > 1000 mg/L (nominal; Circular on Test Methods of New Chemical Substances); read-across
Scophthalmus maximus LL50 (96 h): > 3200 mg/L (nominal; OECD 203); read-across

 

Aquatic invertebrates: 

Acartia tonsa LL50 (48 h): > 10000 mg/L (nominal; ISO 14669); read-across
Daphnia magna EL50 (48 h): > 1000 mg/L (nominal; Circular on Test Methods of New Chemical Substances); read-across

Acartia tonsa LL50 (48 h): 7756 mg/L (nominal; ISO 14669); read-across

Algae:

Pseudokirchneriella subcapitata ErL50 (72 h): > 1000 mg/L (nominal; Circular on Test Methods of New Chemical Substances); read-across

Skeletonema costatum ErL50 (72 h): 1916 mg/L (nominal; ISO 10253); read-across
 

Aquatic chronic toxicity

No observed toxicological effects up to the limit of water solubility(832 µg/L ± 208 µg/L at 20 °C, pH=6.3).

 

Fish: no data available

Aquatic invertebrates:

Daphnia magna NOELR (21 d) ≥ 16 mg/L (nominal, OECD 211); read-across

Daphnia magna NOELR (21 d) ≥ 0.11 mg/L (nominal, OECD 211); read-across

 

Algae: Scenedesmus subspicatus NOELR (72 h): 560 mg/L (nominal; Circular on Test Methods of New Chemical Substances); read-across

 

CLP
Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol (CAS 93334-10-2) is readily biodegradable and has a low potential to bioaccumulate. The substance is not considered to be acutely toxic to fish, aquatic invertebrates or algae since no toxic effects were observed up to the limit of water solubility (
832 µg/L ± 208 µg/L at 20 °C, pH=6.3). Data on chronic toxicity indicate no toxicological effects up to the limit of water solubility. Therefore, Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitoldoes not need to be classified and labelled as environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 286/2011 (4th ATP).

 

DSD
Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitolis readily biodegradable and has a low potential to bioaccumulate. The substance is poorly soluble in water (
832 µg/L ± 208 µg/L at 20 °C, pH=6.3) and no effects occurred up to the water solubility limit in acute tests for fish, algae and aquatic invertebrates. Therefore,fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.