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

Justification for 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 polyol 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 (75.7 % after 28 d; OECD 301B)

Bioaccumulation

Expert statement: Bioaccumulation is assumed to be low.

Aquatic acute toxicity

For fish: no effects up to the limit of water solubility (read across)
For aquatic invertebrates: no effects up to the limit of water solubility (read across)
For algae/aquatic plants: no effects up to the limit of water solubility (read across)

Aquatic chronic toxicity

For fish: no data available

For aquatic invertebrates: no effects up to the limit of water solubility (read across)

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 plan a read across to proposed tests on long term toxicity to invertebrates for the PE esters CAS 15834-04-5 and CAS 68424-31-7. CAS 15834-04-5 has the shortest chain length (C5) of PE esters, it is a mono-constituent and often is a constituent with many of the other polyol esters. Due to its smaller molecular size it is expected to have the highest bioavailability. CAS 68424-31-7 (C5, C7, C8 and C10) is a highly complex UVCB, with varying chain lengths and combinations of structures, representing the medium chain length of the category. As soon as this data is available the hazard and chemical safety assessment will be updated.

For algae/aquatic plant: no effects up to the limit of water solubility (read across) 

Conslusion on classification

CLP:
Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) 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 (< 1 mg/L). Data on chronic toxicity indicate no toxicological effects up to the limit of water solubility. Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) 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:
Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) 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. Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) does not need to be classified and labelled as environmental hazardous according to Directive 67/548/EEC.