Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

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:

Refer to analogue justification document provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other:

Remarks:

source, CAS 710110-76-9, Exxon, 2013, E.fetida 14 d, RL2

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other:

Remarks:

source, CAS 25151-96-6, Emery, 2013, E. fetida 56 d, RL1

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other:

Remarks:

source, CAS 25151-96-6, Emery, 2013, E. fetida 56 d, RL1

Description of key information

NOEC (56 d) of ≥ 1000 mg/kg dw for Eisenia fetida (OECD 222); read-across.

NOEC (14 d) of ≥ 1000 mg/kg dw for Eisenia fetida (OECD 207); read-across.

Additional information

The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114588821-38-01/F a new long-term fish toxicity study with the registered substance will be conducted in the future. The finalised study will be reported in an updated dossier and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of terrestrial toxicity will be evaluated later when the long-term fish toxicity is available.

No study investigating the toxicity of Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids to macroorganisms is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) 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 representatives for the evaluation of the toxicity of the target substance to soil macroorganisms. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.

A chronic test with source substance 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) was conducted according to OECD 222. Eisenia fetida was exposed to the test concentrations 500 and 1000 mg/kg dw in artificial soil for 56 days. Mortality and reproduction were recorded at the end of the study. No effects were observed resulting in a NOEC (28 d) of ≥ 1000 mg/kg dw based on mortality and a NOEC (56 d) of ≥ 1000 mg/kg dw based on reproduction

An acute test with the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) was conducted according to OECD 207. Eisenia fetida was exposed to a test concentration of 1000 mg/kg dw in artificial soil for 14 days. Mortality was recorded at the end of the study. 100% survival was observed in the control group and treatment group resulting in a NOEC (14 d) for mortality of ≥ 1000 mg/kg dw.

A chronic test with source substance 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) was conducted according to OECD 222. Eisenia fetida was exposed to the test concentrations 500 and 1000 mg/kg dw in artificial soil for 56 days. Mortality and reproduction were recorded at the end of the study. No effects were observed resulting in a NOEC (28 d) of ≥ 1000 mg/kg dw based on mortality and a NOEC (56 d) of ≥ 1000 mg/kg dw based on reproduction.

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 valeric, heptanoic and nonanoic acids will not exhibit effects to soil macroorganisms.