Registration Dossier

Diss Factsheets

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:
insufficient hazard data available (further information necessary)

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 read-across was applied for the substance, data will be generated from representative source substances to avoid unnecessary animal testing. Additionally, once the read-across approach is applied, substances will be classified and labelled on this basis.

 

Degradation

Biodegradation: not readily biodegradable: 25.6 - 30.2% (O2 consumption) after 28 d (OECD 301F)

 

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.  

 

Aquatic acute toxicity

Fish: 96 h, LL50 (Oncorhynchus mykiss): > 100 mg/L (nominal, WAF; no observed toxicological effects up to the water solubility limit); read-across
96 h, LL50 (Danio rerio): > 100 mg/L (nominal, WAF; no observed toxicological effects up to the water solubility limit); read-across

Aquatic invertebrates: 48 h, EL50 (Daphnia magna): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across
Aqautic algae: 72 h, ErL50 (Desmodesmus subspicatus): > 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across

Aquatic chronic toxicity

Fish: no data available

Aquatic invertebrates: 21 d, NOELR (Daphnia magna): ≥ 1 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read-across

Aquatic algae: 72 h, NOELR (Desmodesmus subspicatus): ≥ 100 mg/L (nominal; no observed toxicological effects up to the water solubility limit); read across

CLP

Based on the data above, 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate (CAS 68258-72-0) is considered to be not readily biodegradable. The substance is considered not acutely or chronically toxic to aquatic organisms. Thus, 2,2-bis(hydroxymethyl)propane-1,3-diyl didocosanoate does not need to be classified and labelled as environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 605/2014 (6th ATP).

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