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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

Conclusion on classification

The hazard assessment is based on the current data available. New aquatic toxicity studies (OECD 201, OECD 211, OECD 210) are requested for 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (CAS 94279-36-4) based on the ECHA decision on a compliance check (decision number CCH-D-2114517125-59-01/F). The aquatic studies could not finalised until now due to the reasons explained under the respective endpoints (see chapter 6.1.2, 6.1.4 and 6.1.5). The finalised studies will be submitted later based on ECHA decision number CCH-D-2114517125-59-01/F. The aquatic toxicity will be re-evaluated in the update of this dossier as soon as the final aquatic studies will be available.


The assessment with the current data available, was based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006. Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification is provided in the technical dossier (see IUCLID Section 13). Please consider that the originally proposed category approach addressing all Polyfunctional acid esters (PFAE) aromatic is currently under revision and will finally result in an analogue approach for the registration. Therefore, two documents, the category justification and explanatory notes for the analogue approach are provided in Section 13.


According to Article 13 "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 substance. This avoids the need to test every substance for every endpoint”.


Since the group concept is applied to the members of the PFAE aromatic category, data will be generated from representative category members to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.


 


Brief description of the data relevant for classification


Degradation


Biodegradation: not readily biodegradable: 20.7-45% of CO2 evolution (EU method C.4-C)


 


Bioaccumulation


Expert statement: Bioaccumulation is expected to be low (see section 5.3.1 for details)..


 


Aquatic acute toxicity


For fish: 96 h, LC50 (Brachydanio rerio): no effects up to the limit of water solubility (> 4.1 mg/L (measured, WAF))


For aquatic invertebrates: 48 h, EC50 (Daphnia magna): no effects up to the limit of water solubility (> 3.2 mg/L (measured, WAF))


For algae/aquatic plants: 72 h, ErC50 (Scenedesmus subspicatus): no effects up to the limit of water solubility (> 3.5 mg/L (measured, WAF))


 


Aquatic chronic toxicity


For aquatic invertebrates: 21 d, NOEC (Daphnia magna): no effects up to the limit of water solubility (≥ 4.5 mg/L (measured, WAF))


For algae/aquatic plant: 72 h, NOEC (Scenedesmus subspicatus): no effects up to the limit of water solubility (≥ 3.5 mg/L (measured, WAF)


 


CLP:


Based on the data above, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (CAS No. 94279-36-4) is considered to be not rapidly biodegradable but shows low bioaccumulation potential. The substance is poorly soluble in water (< 0.05 mg/L), and no effects occurred up to its water solubility limit in acute tests with fish, algae and daphnia. Valid chronic toxicity data are available for aquatic invertebrates and algae (L(E)C50 values > 1 mg/L). No chronic effects were observed up to the limit of water solubility (NOEC values > 1 mg/L). Therefore, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters does not need to be classified and labelled as environmental hazard according to the 2nd ATP of the Regulation (EC) No. 1272/2008 (CLP).