Reaction product of saturated palm kernel fatty acids and oxybispropanediol

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

other: The data is derived on the basis of weight of evidence approach.

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The data is derived on the basis of an expert weight of evidence approach

Justification for type of information:

No data is available for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol". The toxicokinetics of this substance is therefore assessed in a weight of evidence analysis based on existing data on similar compounds. See the attached report.

The following type of substances were included in the assessments: other glycerol esters (both data and QSAR), glycerols, fatty acids and alcohol ethoxylates. The main data sources were: NICNAS, Danish EPA QSAR, the HERA reports for alcohol ethoxylates and fatty acids.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The data is derived on the basis of a weight of evidence approach. See the attached report.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of saturated palm kernel fatty acids and oxybispropanediol

EC Number:

947-750-3

Molecular formula:

mainly C12 fatty acid but also containing C10, C12, C14, C16 and C18 fatty acids

IUPAC Name:

Reaction product of saturated palm kernel fatty acids and oxybispropanediol

Test material form:

other: Paste

Details on test material:

Same ID as the registered substance

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Key result

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

0.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Applicant's summary and conclusion

Validity criteria fulfilled:

not applicable

Conclusions:

“Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is an UVCB substance. Several test data on short-term toxicity is found on the main constituents, read-across to relevant substance group and expected primary degradation products.
QSAR predictions of short-term toxicity using the Danish QSAR database for both the main constituents and expected degradation products from the primary biodegradation have been used to support and complement the test data.
The data shows that the use of toxicity data for AE probably is conservative, as the effect concentrations of these in general is lower than the observed effect concentrations for both polyglyceryl fatty acid esters, polyglycerols and fatty acids.
As a conservative approach, the conclusions of weight-of-evidence approach is then based on the derived 10% percentile of the AE, leading to the below value:
Short-term toxicity to algae: 72hr-EC50=2.0 mg/L; 72hr-NOEC=0.4 mg/L

Executive summary:

“Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is an UVCB substance. Several test data on short-term toxicity is found on the main constituents, read-across to relevant substance group and expected primary degradation products.

QSAR predictions of short-term toxicity using the Danish QSAR database for both the main constituents and expected degradation products from the primary biodegradation have been used to support and complement the test data.

The data shows that the use of toxicity data for AE probably is conservative, as the effect concentrations of these in general is lower than the observed effect concentrations for both polyglyceryl fatty acid esters, polyglycerols and fatty acids.

As a conservative approach, the conclusions of weight-of-evidence approach is then based on the derived 10% percentile of the AE, leading to the below value:

Short-term toxicity to algae: 72hr-EC50=2.0 mg/L; 72hr-NOEC=0.4 mg/L