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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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 to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.


 


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”.


A read-across approach was applied to this substance for aquatic toxicity and data was compiled from representative source substances to avoid unnecessary animal testing. The target substance will be classified and labelled on this basis.


 


Environmental fate and pathways


Degradation


Biodegradation: not readily biodegradable: 7.6% (CO2 evolution) after 28 d (OECD 301B)


Bioaccumulation


Expert statement: Bioaccumulation is assumed to be low.


 


Aquatic acute toxicity


Fish:


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


Aquatic invertebrates:


no data available


Algae:


no data available


 


Aquatic chronic toxicity


Fish:


no data available


Aquatic invertebrates:


21 d, NOEC (Daphnia magna): ≥ 100 mg/L (nominal, WAF; no observed toxicological effects up to the water solubility limit); read across


Algae:


no data available


 


CLP


Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2- (hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is not readily biodegradable. The bioaccumulation potential of the substance is considered to be low. The substance is considered to be not acutely or chronically toxic to aquatic organisms up to the limit of water solubility. Therefore Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2- (hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) does not need to be classified and labelled as environmental hazardous according to the Regulation (EC) No 1272/2008 and the Regulation (EU) No 944/2013 (5th ATP).