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”.

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

 

Degradation

Biodegradation: readily biodegradable (≥ 86% after 28 d); 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 (< 0.92 mg/L)

Fish: Cyprinus carpio LC50 (96 h): > 100 mg/L (EU Method C.1)

Aquatic invertebrates: Daphnia magna EC50 (48 h): > 1000 mg/L (OECD 202); read across

Algae: Desmodesmus subspicatus EL50 (72 h): > 100 mg/L (OECD 201); read across

Aquatic chronic toxicity

For fish: no data available
NOTE: Although chronic toxicity data is available for members within the polyol esters category in accordance to Regulation (EC) No 1907/2006, Annex IX 9.1 Aquatic toxicity, we propose to test the long term toxicity on invertebrates for this substance in order to confirm that no chronic toxicity to aquatic organisms occurs for the polyol esters with saturated and branched C16/C18. As soon as this data is available the hazard and chemical safety assessment will be updated.

For algae: no data available


CLP: 

Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) is readily biodegradable and has a low potential to bioaccumulate. The substance is considered to be not acutely toxic to fish, aquatic invertebrates or algae since not toxic effects were observed up to the limit of water solubility (< 0.93 mg/L). Data on chronic toxicity of polyol esters indicate no toxicological effects up to the limit of water solubility. A study on the long-term toxicity of the substance is proposed. As soon as this data is available the hazard and chemical safety assessment will be updated. Therefore, Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) does 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 (2nd ATP).

DSD: 

Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) is readily biodegradable and has a low potential to bioaccumulate. The substance is poorly soluble in water and no effects occurred up to the water solubility limit (< 1 mg/L) in acute tests for fish, algae and aquatic invertebrates. Therefore, Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di- and triesters with trimethylolpropane (former CAS 85005-23-8) does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.