Registration Dossier

Administrative data

Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
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 find QMRF and QRPF enclosed

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 210 (Fish, Early-Life Stage Toxicity 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:
28 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 28d-NOEC of the test item to fish 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:

QSAR prediction adapted to OECD 210 test method

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 28d-NOEC of the test item to fish 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