Registration Dossier

Administrative data

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:
other: Weight of evidence assessment based on structural analogue and hydrolysis products
Justification for type of information:
No data is available for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol". The properties 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 short-term toxicity is based on a weight-of-evidence approach.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Paste
Details on test material:
Same ID as the registered substance

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

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 values:

Short-term toxicity to fish: 96hr-LC50=1.3 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 values:

Short-term toxicity to fish: 96hr-LC50=1.3 mg/L