Docosanoic acid, monoester with glycerol

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

other: Weight of evidence

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

As no specific data on the acute toxicity for “Docosanoic acid, monoester with glycerol” (CAS 30233-64-8) is available, a weight of evidence analysis based on existing data on the group of mono-, di- and triglycerides, fatty acids, all components with similar properties has been performed. Several test data on acute toxicity was identified on the group of mono-, di- and triglycerides - all concluding no acute toxicity up to the water solubility. Detailed information is given in the attached report.

Qualifier:

no guideline followed

Principles of method if other than guideline:

No acute fish toxicity data is available for the substance. The substance is a mono-glyceride, and the acute toxicity to fish is based on a WoE approach (see attached WoE document for details).

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.001 mg/L

Validity criteria fulfilled:

not specified

Conclusions:

The substance is a mono-glyceride, and based on a WoE approach, it is concluded that the substance is not acutely toxic to fish in concentrations up the water solubility limit of the substance.

Executive summary:

No acute fish toxicity data is available for the substance. The substance is a mono-glyceride, and the acute toxicity to fish is based on a WoE approach (see attached WoE document for details).

The substance is a mono-glyceride, and based on a WoE approach, it is concluded that the substance is not acutely toxic to fish in concentrations up the water solubility limit of the substance.

Description of key information

Glycerol monobehenate is a mono constituent substance with a purity of 80-90%. Test data on short-term toxicity to fish are not available for Glycerol monobehenate. The environmental toxicity of this substance was therefore assessed based on a weight of evidence analysis.
A large set of test data on environmental toxicity have been found for the group of mono-, di- and triglycerides and on the environmental toxicity of the hydrolysis products of the substance to constitute a basis for conclusion on short-term toxicity of the substance.
Several test data on the acute toxicity is found on the group of mono-, di- and triglycerides and fatty acids - all concluding that no acute toxicity is shown at concentrations up to the water solubility. Hereby, a huge data set is available for the deriving a conclusion on the acute toxicity of the substance.
Based on the studies available in the present analysis, it is concluded that the compound “Docosanoic acid, monoester with glycerol” is not acutely toxic at concentrations up the water solubility of the substance:
• LC50(Fish, 96 hr): > water solubility

The available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. The weight-of-Evidence approach is justified based on common functional group and common precursors/breakdown products. The information from
these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.