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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The substance is reliably predicted to be NON-mutagenic by QSAR models.

Link to relevant study records

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Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
Documentation about the justification is provided in attachment (See Supporting information). The reliability assessment of the prediction is presented in the attached document as well (QPRF).
Qualifier:
equivalent or similar to
Guideline:
other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
CC1(C)NC(=O)NC1=O
Genotoxicity:
negative
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

The prediction was deemed to be reliable on the basis of the parameters listed above. The molecule falls into the applicability domain of the model.

Conclusions:
The molecule was predicted to be NON-mutagenic.
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification
Justification for type of information:
Documentation about the justification is provided in attachment (See Supporting information). The reliability assessment of the prediction is presented in the attached document as well (QPRF).
Qualifier:
equivalent or similar to
Guideline:
other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
O=C1NC(=O)C(N1)(C)C
Genotoxicity:
negative
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

The prediction was deemed to be reliable on the basis of the parameters listed above. The molecule falls into the applicability domain of the model.

Conclusions:
The molecule was predicted to be NON-mutagenic.

Additional information

Justification for classification or non-classification

Although the molecule is reliably predicted to be NON mutagenic, data available are deemed to be inconclusive for the classification in accordance with CLP regulation.