Registration Dossier

Administrative data

Endpoint:
activated sludge respiration inhibition testing
Type of information:
other: Information based on a weight of evidence approach
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The end-point is based on an expert weigthhtf evidence approach 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 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 information 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 concentrationsopen allclose all
Key result
Duration:
3 h
Dose descriptor:
IC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration
Key result
Duration:
3 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
inhibition of total respiration

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.
The lowest effect concentration to microorganism is found for 1,2,3-Propanetriol, homopolymer, decanoate/Polygyceryl-6 Dicaprate with a 3hr-NOEC=1000 mg/L and a 3hr-IC50>1000 mg/L. This is to be used for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”.
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.

The lowest effect concentration to microorganism is found for 1,2,3-Propanetriol, homopolymer, decanoate/Polygyceryl-6 Dicaprate with a 3hr-NOEC=1000 mg/L and a 3hr-IC50>1000 mg/L. This is to be used for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”.