Registration Dossier

Administrative data

Endpoint:
fish early-life stage toxicity
Type of information:
other: Weight-of-evidence
Adequacy of study:
weight of evidence
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Weight of evidence assessment based on structural analogue
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 a group of 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:
Data 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

Test organisms

Test organisms (species):
Pimephales promelas

Results and discussion

Effect concentrations
Key result
Duration:
28 d
Dose descriptor:
EC10
Effect conc.:
>= 0.213 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Survival
Remarks on result:
other: See WoE document for details

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
As a conservative approach, the conclusion of the weight-of-evidence approach is based on lowest long-term EC10/NOEC for fish of the AE, leading to the value: Long-term toxicity to fish: EC10≥0.213 mg/L.
Executive summary:

“Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is an UVCB substance. Data on long-term toxicity are based on the relevant substance group, Alcohol Ethoxylates (AE)

As a conservative approach, the conclusion of the weight-of-evidence approach is based on lowest long-term EC10/NOEC for fish of the AE, leading to the value: Long-term toxicity to fish: EC100.213 mg/L.