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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 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

Readily biodegradable: 75% in 28 d (OECD 301 F)

Bioaccumulation

log Pow > 10 (EPISuite v4.10, KOWWIN v1.68)

 

Aquatic short-term toxicity

Fish

No effects up to the limit of water solubility (OECD 203 & ISO 7346-1, D. rerio); read-across

Aquatic invertebrates

No effects up to the limit of water solubility (OECD 202, D. magna)

Aquatic algae

No effects up to the limit of water solubility (OECD 201, S. capricornutum); read-across

 

Aquatic long-term toxicity

Fish

Data waiving

Aquatic invertebrates:

No effects up to the limit of water solubility (OECD 211, D. magna); read-across

Aquatic algae

No toxic effects to aquatic algae up to the limit of water solubility (OECD 201, S. capricornutum); read-across

 

Conclusion on CLP

Based on the data above, the substance is rapidly degradable, and neither short-term nor long-term toxic effects towards aquatic organisms of all three trophic levels were observed up to the limit of the water solubility (< 0.05 mg/L). Therefore, Tetraesters of 2,2-bis(hydroxymethyl)propane-1,3-diol and decanoic and octanoic acid (CAS 68441-68-9) does not need to be classified and labelled as environmental hazardous, according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs).