Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

Please refer to the Analogue Justification provided in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

reproduction

Remarks on result:

other:

Remarks:

source, CAS 68443-84-5, Nyco, 2013, D.magna, RL2

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

>= 135 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

reproduction

Remarks on result:

other:

Remarks:

source, CAS 71010-76-9, Exxon, 2013, D.magna, RL1

Description of key information

No effects up to the highest concentration tested; read-across.

Additional information

No study investigating the long-term toxicity of Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids to aquatic invertebrates is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Triisononanoic acid, triester with 2,2’-[oxybis(methylene)]bis[2-(hydroxymethyl)propane-1,3-diol] tris(2-ethylhexanoate) (CAS 68443-84-5) and Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) is applied.

Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substances, the source substances are considered suitable representative for the evaluation of the long-term toxicity of the target substance to invertebrates. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.

The first study investigated the long-term effects of the source substance Triisononanoic acid, triester with 2,2’-[oxybis(methylene)]bis[2-(hydroxymethyl)propane-1,3-diol] tris(2-ethylhexanoate) (CAS 68443-84-5) to aquatic invertebrates according to OECD guideline 211 using Daphnia magna as test organism. Water accommodated fractions (WAFs) of 0, 10 and 100 mg/L were applied corresponding to a measured test concentration of 0.52 and 0.638 mg/L, respectively. At test termination after 21 days an EL50 > 100 mg/L (nominal), was determined.
The study with the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) investigated the long-term toxicity to aquatic invertebrates under semi-static conditions according to OECD 211 using Daphnia magna as test organism. A loading rate of 135 mg/L (nominal) was applied in the 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 loading rate.

Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids will not result in toxicity up to the limit of water solubility.