4,5-dihydroxy-1,3-dimethylimidazolidin-2-one

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

06.09.2022

Reliability:

2 (reliable with restrictions)

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:

Please refer to attached QMRF and QPRF Documents.

Qualifier:

according to guideline

Guideline:

other: REACH guidance on QSAR R.6

Principles of method if other than guideline:

Calculation of Long-Term toxicity in fish. Software used: ECOSAR 2.2 for chemical class "Substituted Ureas"

GLP compliance:

no

Specific details on test material used for the study:

SMILES: CN1C(O)C(O)N(C)C1=O

Analytical monitoring:

not required

Test organisms (species):

other: fish

Water media type:

freshwater

Total exposure duration:

30 d

Remarks on exposure duration:

chronic exposure

Key result

Duration:

30 d

Dose descriptor:

other: ChV

Effect conc.:

31 100 mg/L

Remarks on result:

ChV (chronic value, QSAR)

Remarks:

The substance is within the applicability domain of the model. ECOSAR class "Substituted Ureas".

Validity criteria fulfilled:

yes

Conclusions:

Using ECOSAR v2.2 the long-term toxicity ChV value for fish was calculated to be 31100 mg/L. The substance is within the applicability domain of the model.

Executive summary:

The long-term toxicity in fish was calculated using ECOSAR v2.2 from US Environmental Protection Agency.

 

The adequacy of a prediction depends on the following conditions:

a) the (Q)SAR model is scientifically valid: the scientific validity is established according to the OECD principles for (Q)SAR validation;

b) the (Q)SAR model is applicable to the query chemical: a (Q)SAR is applicable if the query chemical falls within the defined applicability domain of the model;

c) the (Q)SAR result is reliable: a valid (Q)SAR that is applied to a chemical falling within its applicability domain provides a reliable result;

d) the (Q)SAR model is relevant for the regulatory purpose.

 

For assessment and justification of these 4 requirements the QMRF and QPRF files were developed and attached to this study record.

 

Description of the prediction Model

The prediction model was descriped using the harmonised template for summarising and reporting key information on (Q)SAR models. For more details please refer to the attached QSAR Model Reporting Format (QMRF) file. 

 

Assessment of estimation domain

The assessment of the estimation domain was documented in the QSAR Prediction Reporting Format file (QPRF). Please refer to the attached document for the details of the prediction and the assessment of the estimation domain.

Description of key information

Using ECOSAR v2.2 the long-term toxicity ChV value for fish was calculated to be 31100 mg/L. The substance is within the applicability domain of the model.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

31 100 mg/L

Additional information

Using ECOSAR v2.2 the long-term toxicity ChV value for fish was calculated to be 31100 mg/L. The substance is within the applicability domain of the model. No effects in the acute aquatic studies were observed and in combination with the QSAR prediction, it can be concluded that the test item doesn't pose any risk to the aquatic environment and the performance of a new vertebrate test is considered scientifically not justified.