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 (read-across approach), 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 category concept is applied to the polyol esters, data gaps will be filled by interpolation, as part of a read across approach from a representative category member(s) to avoid unnecessary animal testing. Additionally, once the category concept is applied, substances will be classified and labelled on this basis.

Brief description of the data relevant for classification

Degradation

Biodegradation: Readily biodegradable: 71.9 - 99.8% (CO2 evolution) after 28 d (OECD 301B) (read-across)

Bioaccumulation:

Expert statement; Bioaccumulation is expected 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 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 shorter chain lengths (C5). 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)

Conclusion on classification

CLP:

Based on the data above, 2,2-bis[[(1-oxopentyl) oxy]methyl]propane-1,3-diyl divalerate (CAS-No. 15834-04-5) is considered to be rapidly degradable. The acute aquatic toxicity L(E)C(L)50 values are > 1 mg/L or above the water solubility (< 1 mg/L) limit for fish, invertebrates and algae. Valid chronic toxicity data for category members are available, and the NOEC is determined to be above the water solubility limit. 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, 2,2-bis[[(1-oxopentyl) oxy]methyl]propane-1,3-diyl divalerate (CAS-No. 15834-04-5) 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).  The classification will be re-evaluated when the additional study on aquatic invertebrates is available.

DSD:

The acute aquatic toxicity L(E)C(L)50 values are > 100 mg/L or above the water solubility limit for fish, invertebrates and algae. Therefore, 2,2-bis[[(1-oxopentyl) oxy]methyl]propane-1,3-diyl divalerate (CAS-No. 15834-04-5) does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.