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:
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

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).