Pentaerythritol tetrastearate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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:

other:

Reason / purpose for cross-reference:

other:

Reason / purpose for cross-reference:

other:

Reason / purpose for cross-reference:

other:

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 85711-45-1, Oleon, 2013, D. rerio 96 h, RL1

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

loading rate (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other: , source, RA-A, CAS 85711-45-1, Oleon, 2013, D. rerio 96 h, RL1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 62125-22-8, 1997, D. rerio 96 h, RL2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 62125-22-8, 1997, Danio rerio 96 h, RL2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 71010-76-9, Exxon, 2009, B. rerio 96 h, RL2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.704 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 71010-76-9, Exxon, 2009, B. rerio 96 h, RL2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 19321-40-5, 1997, C. carpio 96 h, RL2

Duration:

96

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 19321-40-5, 1997, C. carpio 96 h, RL2

Description of key information

No effects up to the limit of water solubility; read-across.

Additional information

No study investigating the short-term toxicity of pentaerythritol tetrastearate (CAS 115-83-3) to fish is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol (CAS 85711-45-1), 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8), decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and pentaerythritol tetraoleate (CAS 19321-40-5) 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 to be suitable representatives for the evaluation of the short-term toxicity of the target substance to fish. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.

The first study investigated short-term toxicity of fatty acids, C16-18 and C18-unsaturated, esters with pentaerythritol (CAS 85711-45-1) to freshwater fish according to OECD 203 under static conditions using Danio rerio. Nominal concentration of 100 mg/L was applied. A water accommodated fraction (WAF) was prepared by adding the required amount of test substance to water with subsequent stirring. The lower phase was used as test medium. DOC analysis of the test substance concentrations indicated that the substance is not soluble in the test medium and the evaluation is hence based on nominal concentrations. No mortalities occurred after the test duration of 96 hours resulting in an LL50 of > 100 mg/L (nominal). Short-term toxicity of 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS 62125-22-8) to freshwater fish was investigated according to OECD 203 under semi-static conditions using Danio rerio as test organism. Nominal concentrations of 10, 18, 32, 56 and 100 mg/L were applied. A stock solution was prepared daily and diluted appropriately. No mortalities occurred after the test duration of 96 hours resulting in an LC50 of > 100 mg/L. Short-term toxicity of decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) to freshwater fish was investigated according to OECD 203 under static conditions using Danio rerio as test organism. Nominal test concentrations of 100 and 150 mg/L were applied. Test substance monitoring using TOC analysis measured test concentrations of 0.696 and 0.704 mg/L, respectively. Undissolved test material was not removed from the test system; however, this is considered negligible, because no mortality was observed in any treatment and the control throughout the test period of 96 h. Hence, the 96 h-LC50 is determined to be > 0.704 mg/L (arithmetic mean). Short-term toxicity of pentaerytritol tetraoleate (CAS 19321-40-5) to freshwater fish was investigated according to OECD 203 under static conditions using Cyprinus carpio as a test organism. A nominal test concentration of 100 mg/L was applied by preparing a stock solution was prepared in acetone. Blank and solvent controls were also tested. No mortalities occurred after the test duration of 96 hours resulting in an LC50 of > 100 mg/L.

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 pentaerythritol tetrastearate (CAS 115-83-3) will not exhibit short-term effects to fish up to the limit of water solubility.