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 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”.

Classification related key information

Readily biodegradable: 70% in 28 days (OECD 301F); read across

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

Acute toxicity:

-             Fish: No toxicity up to the limit of water solubility; read across

-            Aquatic invertebrates: No toxicity up to the limit of water solubility; read across

-            Algae: No toxicity up to the limit of water solubility; read across

Chronic toxicity: 

-    Aquatic invertebrates: No toxicity up to the limit of water solubility; read across

·        Fish: no data available

·        Algae: No toxicity up to the limit of water solubility; read across

Conclusion on classification

The substance Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0) is readily biodegradable and has a low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 values are > 1 mg/L for fish, aquatic invertebrates and algae. Adverse effects were not observed up to the limit of water solubility. Furthermore the substance is considered as not chronically toxic (NOELR (21 d) ≥ 0.11 g/L. Thus, the substance does not need to be classified and labelled according to the 6th ATP of Regulation (EC) No. 1272/2008 (CLP).

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