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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

No chronic effects to aquatic invertebrates up to the limit of water solubility (< 0.006 mg/L).

Key value for chemical safety assessment

Additional information

In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to two structurally related category members decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) anddecanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate(CAS 11138-60-6) was conducted to fulfill the data requirements according to Annex IXfatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2) in regard to toxicity to aquatic invertebrates. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the category justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment. The fatty acid chain lengths of C5-C10 of the read-across substances are in a similar range to those of the target substance. In addition, the first read-across substance contains the same alcohol, pentaerythritol, and is also a tetra-ester.

The first study with the read-across substance decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS No. 71010-76-9) was conducted under semi-static conditions according to OECD 211 usingDaphnia magnaas test organism (Letinski & Bragin, 2011). The test solution was prepared by adding the appropriate amount of test substance with subsequent stirring and sampling of the aqueous portions (WAFs) through the outlet at the bottom of the vessels. A loading rate WAF of 135 mg/L (nominal) was applied in a limit test. No significant effect on reproduction was observed in the treatment throughout the test period of 21 d. Hence, the 21 d-NOELR is determined to be > 135 mg/L on the basis of the nominal test concentration.

The second GLP study investigating the long term toxicity to aquatic invertebrates was performed with the read-across substancedecanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate(CAS 11138-60-6) according to OECD guideline 202 "Daphnia sp. Acute Immobilization Test and Reproduction Test", Part 2 (1993) under semi-static conditions (Low, 1996). This test guideline is similar to OECD 211 which was adopted in 1998. The study period of 15 days does not meet the criteria of today standard methods recommending 21 days study duration. However, according to the Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2012) the study can be regarded as valid for a long-term evaluation as corresponding criteria were fulfilled (e.g. 80% survival in the control, surviving females produce three broods in 21 days or less, > 60 brood neonates per female in the control on average). In addition, all requested endpoints could be determined (time to first brood, number of offspring produced per female, growth and survival) and NOELR values for survival or reproductive endpoints could be calculated. In this studyDaphnia magnawere exposed to nominal concentrations of 0, 24, 97, 242, 1018 and 2570 mg/L (prepared as water accommodated fraction, WAF). No effects were observed up to the highest test concentration resulting in a NOELR of ≥ 2570 mg/L based on reproduction and immobilization.

Based on these results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded thatfatty acids, C5-9 tetraesters with pentaerythritol (CAS 67762-53-2)will not exhibit long-term effects to aquatic invertebrates up to the limit of water solubility.As it can be seen in the data matrix of the category justification in section 13 and the overall endpoint summary IUCLID 6.1, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results, i.e. no toxic effects to aquatic organisms were observed up to the limit of water solubility