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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Additional information

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.


In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the PFAE aromatic category members are not considered to be harmful to aquatic organisms based on the results from available short-term studies with fish, aquatic invertebrates and algae and available long-term results on toxicity to aquatic invertebrates and algae.


Short-term toxicity to fish, aquatic invertebrates and algae


Short-term toxicity studies with fish, algae and aquatic invertebrates conducted according to internationally accepted guidelines are available for the PFAE aromatic category member 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (CAS No. 90218-76-1). No effects were observed up to the limit of water solubility (WS < 0.05 mg/L).


Long-term toxicity to fish, aquatic invertebrates and algae


There are no long-term fish studies available for the PFAE aromatic category members. The chemical safety assessment according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish. Thus, in accordance to Annex IX, column 2, 9.1, no further long-term toxicity test to fish is proposed. Available short-term studies for fish, daphnia and algae, all indicate no potential for aquatic toxicity (no toxicity up to the limit of the water solubility). Moreover, long term NOECvalues obtained from aquatic invertebrates and algal growth studies for the PFAE aromatic category member 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (CAS No. 90218-76-1) are clearly above the limit of water solubility (≥ 4.5 mg/L (measured, WAF) and (≥ 3.5 mg/L (measured, WAF, respectively). Due to its enhanced ultimate biodegradability it is not likely that aquatic organisms will be exposed to the PFAE aromatic category members since they will be ultimately degraded in sewage treatment plants and only low concentrations (if any) will be released into the environment.. Based on this information and the above mentioned results for aquatic invertebrates and algae, it can be concluded that no substance within the category is expected to exhibit chronic toxicity to fish up to the limit of water solubility. Hence due to animal welfare reasons, no further long-term fish tests were proposed.


Toxicity to microorganisms


Activated sludge respiration inhibition tests conducted according to OECD 209 are not available for the PFAE aromatic category members. However, an oxygen consumption test according to a German national guideline (DIN 38412, part 27) is available for 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (CAS No. 90218-76-1), showing no effects on Pseudomonas putida. Since the test shows no adverse effects even at concentrations well above the limit of water solubility (i.e. L(E)C50 > 1000 mg/L, WS < 0.05 mg/L), disturbances in sewage treatment plants are not anticipated for the members of the PFAE aromatic category. Furthermore, the results of the biodegradation test conducted with this substance show that the category members can be considered to be enhanced ultimately biodegradable, which indicates that the substances are metabolized by activated sludge microorganisms. Hence, toxicity to sludge microorganisms up to the limit of water solubility for the PFAE aromatic category members is unlikely.


Conclusion


No effects on aquatic organisms were observed in the available studies for the PFAE aromatic category members for any of the three trophic levels tested (fish, daphnia, algae) up to the limit of water solubility in short-term toxicity tests. Available long-term data on aquatic invertebrates and algae indicate also no chronic effects up to the limit of the water solubility (< 0.05 mg/L).