Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate

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)

Adequacy of study:

key study

Justification for type of information:

For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.439 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No effects on behaviour or survival of fish were detected during the test course up to and including the highest test concentration of 0.439 mg/L.

Reported statistics and error estimates:

Not applicable

Sublethal observations / clinical signs:

Neither biological effects nor mortality occurred during the test.

Validity criteria according the OECD guideline 203 were met:  

• Mortality did not exceed 10 % in the controls.  

• The dissolved oxygen concentration was ≥ 60 % in test vessels throughout the test.

Validity criteria fulfilled:

yes

Conclusions:

The LC50 was determined to be > 0.439 mg/L Sodium-Isostearoyl-Lactylate (geometric mean measured).

Executive summary:

In a 96-h acute toxicity study, zebra fish (Danio rerio) were exposed to Sodium-Isostearoyl-Lactylate at nominal concentrations of 0.0 (control) and 6.25, 12.5, 25.0, 50.0 and 100.0 mg/L under semi-static conditions. The LC₅₀ value, based on mortality, was > 0.439 mg/L (geometric mean measured concentration). Sublethal effects were not observed.

Based on the results of this study, the test item would be not classified as toxic to zebra fish in accordance with the CLP classification system.

This toxicity study is classified as acceptable and satisfies the guideline requirement for the zebra fish acute toxicity study.

Results synopsis

Test organism size/age: Danio rerio (size 2.0 cm ± 1.0 cm)

Test type: Semi-static

LC₅₀ > 0.439 mg/L

Endpoint(s) effected: Mortality, other effects (i.e. swimming behaviour, colour, respiratory function or any other observable morphological or visual behavioural criterion)

This information is used in a read-across approach in the assessment of the target substance.

For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Description of key information

To evaluate the toxicity of sodium lauroyl lactylate (SLL) to fish read-across from sodium isostearoyl lactylate (ISL) is available.

In a valid 96-h acute toxicity study, zebra fish (Danio rerio) were exposed to sodium isostearoyl lactylate at nominal concentrations of 0.0 (control) and 6.25, 12.5, 25.0, 50.0 and 100.0 mg test item/L under semi-static conditions. The LC₅₀ value, based on mortality and sublethal effects, was > 0.439 mg/L (geometric mean measured concentration). This was the maximum attainable test substance concentration. Neither mortality nor any sublethal effects were observed.

The absence of any mortality indicates that, according to the threshold approach for acute fish toxicity, fish is not the most sensitive group of test organisms after short-term exposure to sodium isostearoyl lactylate.

This information is used in a read-across approach in the assessment of the target substance sodium lauroyl lactylate (SLL).