Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 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 data on the toxicity of the substance are not available the assessment is based on structural analogue substances to avoid unnecessary animal testing.

 

Classification related key information

Biodegradation in water: screening tests: 76 - 96% in 28 days (OECD 301B); read across

Bioaccumulation: No significant bioaccumulation in biota is expected for this substance (see IUCLID section 5.3).

Acute toxicity:

No observed toxicological effects up to the limit of water solubility (< 0.05 mg/L)

Fish: LC50 (96 h) (Salmo gairdneri): > 1000 mg/L (OECD 203); read across.

Aquatic invertebrates: EL50 (48 h) (Daphnia magna): > 100 mg/L (OECD 202); read-across

Algae: EL50 (72 h) (Scenedesmus capricornutum): > 1000 mg/L (nominal) (OECD 201); read-across

Algae: EL50 (72 h) (Pseudokirchnerella subcapitata): > 100 mg/L (nominal) (EPA OPPTS 850.5400); read-across

Chronic toxicity:

No observed toxicological effects up to the limit of water solubility (< 0.05 mg/L)

Aquatic invertebrates: NOELR (21 d) (Daphnia magna): > 135 mg/L (OECD 211); read-across

Algae: NOEC (72 h) (Scenedesmus capricornutum): ≥ 1000 mg/L (OECD 201); read-across

 

Non-classification justification according to CLP

The substance 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) is considered to be rapidly degradable and has low potential for bioaccumulation. The acute L(E)C50 values reported for fish, aquatic invertebrates and algae show no effects up to the limit of water solubility. Furthermore the substance is considered to be not chronically toxic. Data on the long-term toxicity show no effect up to the limit of water solubility. Thus the substance does not need to be classified and labelled according to the 2nd ATP of Regulation (EC) No.1272/2008 (CLP).

Non-classification justification according to DSD

The substance 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35-2) is considered to be rapidly degradable and have low potential for bioaccumulation. The acute L(E)C50 values reported for fish, aquatic invertebrates and algae show no effects up to the limit of water solubility. Thus the substance does not need to be classified and labelled as environmental hazard according to Directive 67/548/EEC.