Fatty acids, C16-18, stearyl esters

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:

Refer to the analogue approach justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: RA-A, CAS 93803-87-3, Notox, 1998

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: RA-A, CAS 101227-09-2, Henkel, 2001

Conclusions:

The key value retained for the short-term toxicity of the target substance to fish is an LL50 (96 h) of > 100 mg/L (nominal) and an LC50 (96 h) of > 10000 mg/L (nominal) based on experimental studies with two structurally and chemically related source substances (OECD 203); read-across

Description of key information

No effects up to the limit of water solubility (ISO 7346-1, OECD 203); read-across

Additional information

There is no study available, in which the short-term toxicity of the target substanceFatty acids, C16-18, stearyl esters (CAS 85536-04-5) to fish was assessed. Therefore, read-across to the two structurally and chemically closely related source substances Fatty acids, C16-18, 2-hexyldecyl esters (CAS 101227-09-2) and 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5. The source substances are characterized by similar fatty acid chain lengths and alcohol components as the target substance and are therefore considered suitable representatives for the assessment of the short-term toxicity of the target substance to fish. A detailed justification of the analogue approach is provided in IUCLID section 13.

The available study with the source substance Fatty acids, C16-18, 2-hexyldecyl esters (CAS 101227-09-2) was conducted according to ISO 7346-1. In a static test, the freshwater fish Brachydanio rerio was exposed to nominal test item concentrations of 1000, 3000, and 10000 mg/L, which were directly added to the test vessels without filtration.

After 96 h, no mortality was recorded even though oxygen concentrations could not be maintained at > 60% throughout the study (recorded range 47 – 96%). Thus, an LC50 (96 h) of > 10000 mg/L (nominal) was derived and it was concluded that Fatty acids, C16-18, 2-hexyldecyl esters (CAS 101227-09-2) does not cause short-term toxicity to fish up to the limit of water solubility.

The available study with source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted according to OECD 203 and in compliance with GLP.

In a static test, the carp Cyprinus carpio was exposed to two Water Accommodated Fractions with nominal loading rates of 10 and 100 mg/L. Chemical analysis of actual test item concentrations was not possible due to the very low water solubility of the substance.

After 96 h, no mortality was observed and an LL50 (96 h) of > 100 mg/L (nominal) was derived. Thus, it was concluded that 2-octyldodecyl isooctadecanoate does not cause short-term toxicity to fish up to the limit of water solubility.

 

Based on the high degree of structural and chemical similarity between the target and the selected source substances, the target substance is expected to exhibit a similar ecotoxicological profile as the source substances. Therefore, it is concluded that the target substanceFatty acids, C16-18, stearyl esters (CAS 85536-04-5) does not cause short-term toxicity to fish up to its limit of water solubility (< 0.507 mg/L, 20 °C, OECD 105).