Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

There are two studies on the substance (in the case of long-term toxicity to aquatic invertebrates and vertebrates), and two read-across studies to algae and microorganisms. Read-across to the properties of Hexanoic acid, 3,5,5-trimethyl-, 1,1'-[2-ethyl-2-[[(3,5,5-trimethyl-1-oxohexyl)oxy]methyl]-1,3-propanediyl] ester (EC 613-848-7, CAS65870-94-2), Fatty acid polyols (Fatty acids, C5-9, esters with pentaerythritol (EC 270-290-3, CAS 68424-30-6) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (EC 234-392-1, CAS 11138-60-6)) and their analogues is applicable based on the similarity in structure and physico-chemical properties. Data on structural analogues of the read-across substances are also presented as supporting information and can therefore be used for read-across. The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.


 


Long-term fish toxicity: In this key study, fathead minnow (Pimephales promelas) were exposed to a Water Accommodated Fraction of the substance at nominal loading rates of 1.25, 2.5, 5, 10 or 20 mg/L under semi-static conditions for 21 days. The LL50 (21 d) was > 10 mg/L loading rate WAF. The No Observed Effect Loading Rate was 10 mg/L loading rate WAF. The substance is not harmful to fish after prolonged exposure.


 


Long-term toxicity to aquatic invertebrates:


One reliable study is available. In this study (Sacker, 2022) performed under GLP according to OECD TG 211, EC Method C.20 and draft OPPTS 850.1300, Daphnia magna were exposed to the substance under semi-static conditions for 21 days. Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test item was prepared as a Water Accommodated Fraction (WAF). Based on the results of the acute toxicity test daphnids (10 replicates of a single daphnid per group) to WAFs of the test item at a nominal loading rate of 10 mg/L. The numbers of live and dead adult Daphnia and young daphnids (live and dead) were determined daily. The 21-Day EL50 (immobilization) value, based on nominal test concentrations, for the parental Daphnia generation (Pi) was > 10 mg/L loading rate WAF. The 21-Day EL50 (reproduction) value based on nominal test concentrations was > 10 mg/L.


 


Toxicity to algae: One reliable study is available (Vreyenhoef, 2014). In this study Pseudokirchneriella subcapitata were exposed to a Water Accommodated Fraction of an analogue substance (EC 613 -848 -7) at a nominal loading rate of 100 mg/L under static conditions for 72 hours. The ErL50 (72 h) value was > 100 mg/L loading rate WAF. The NOELR was 100 mg/L loading rate WAF. The substance is not harmful to algae.


 


Toxicity to micro-organisms: One reliable study is available (Roulstone, 2013). In this study activated sewage sludge was exposed to aqueous dispersions of an analogue substance (EC 613 -848 -7) at up to 1000 mg/L with the addition of synthetic sewage as a respiratory substrate for 3 hours. Based on the rate of respiration, the EC50 (3 h) was > 1000 mg/L and the NOEC (3 h) was 1000 mg/L. The substance is not harmful to microorganisms.

Additional information