Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information

The substance was predicted to be toxic to development by QSAR models.

Link to relevant study records

Referenceopen allclose all

Endpoint:
developmental toxicity
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
Guideline:
other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
Specific details on test material used for the study:
CC1(C)NC(=O)NC1=O
Developmental effects observed:
yes

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 substance was predicted to be toxic for development.
Endpoint:
developmental toxicity
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 and falling into its applicability domain, with limited 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
Guideline:
other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
Specific details on test material used for the study:
CC1(C)NC(=O)NC1=O
Developmental effects observed:
yes

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 substance was predicted to be toxic for development and reproduction.

Justification for classification or non-classification

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

Additional information