Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
April 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
Kindly refer QMRF/QRPF attached

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
ECHA guidance on QSAR, R6
GLP compliance:
no
Remarks:
not relevant for QSAR

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Synthetic squalane

Results and discussion

Effect concentrations
Key result
Duration:
21 d
Dose descriptor:
NOEC
Remarks on result:
other: NOEC> > water solubility limit

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test item falls within the domain of the model except for the descriptor domain where it falls beyond the limit where the toxicity value is predicted as greater than the water solubility value within the exposure period of the test.
This results is supported by the fact than the substance can be considered as highly insoluble. Therefore, this endpoint result can be considered valid for use in risk assessment and classification and labelling.
The 21d-NOEC of the test item to daphnids was predicted as greater than the subcooled liquid water solubility value within the exposure period of the test.
95% confidence interval (α = 0.05): not determined.
Executive summary:

In a QSAR model adapted to OECD 211 test guideline:

The test item falls within the domain of the model except for the descriptor domain where it falls beyond the limit where the toxicity value is predicted as greater than the water solubility value within the exposure period of the test.

This results is supported by the fact than the substance can be considered as highly insoluble. Therefore, this endpoint result can be considered valid for use in risk assessment and classification and labelling.

The 21d-NOEC of the test item to daphnids was predicted as greater than the subcooled liquid water solubility value within the exposure period of the test.

95% confidence interval (α = 0.05): not determined.