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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Additional information

The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

 

Data on the aquatic toxicity of propylene dinonanoate (CAS 41395-83-9) are not available. Therefore, the toxicity was assessed by means of a read-across approach with experimental data from two structurally and chemically closely related source substances in order to fulfill the standard information requirements laid down in Annex VIII of the REACh Regulation (EC) No 1907/2006. The selected source substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) are characterized by similar fatty acid and alcohol components as well as very similar chain length of the molecule compared to the target substance.

 

According to Article 13(1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” For aquatic toxicity in particular, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). In regard to the general rules for grouping of substances and the read-across approach, the regulation specifies (Annex XI, Item 1.5) that substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

 

Based on the high degree of structural similarity as well as similar physico-chemical properties of the target and selected source substances, the target substance is expected to have a similar ecotoxicological profile as the selected source substances.

All available studies were performed according to internationally accepted guidelines and GLP. No short-term effects were observed for any of the trophic levels up to the limit of water solubility. Furthermore long-term toxicity results available for aquatic invertebrates and algae, did not indicate any long-term hazard for these trophic levels.

 

No toxicity of the substance to sewage treatment plant microorganisms is expected, based on the study with the read across substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8). Furthermore, the biodegradability studies with the read across substance octanoic acid and propylene glycol (CAS 68583-51-7) showed that microorganisms rapidly degrade the substance, which again underpins the assumption of no hazard to aquatic microorganisms.

Based on all available data, it is concluded that propylene dinonanoate (CAS 41395-83-9) does not cause adverse effects to aquatic organisms up to the limit of water solubility and is not expected to affect the degradation process in sewage treatment plants.