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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

According to REACH Regulation (EC) No 1907/2006 Annex VII section 8.3 column 2 the in vivo skin sensitization test is not necessary if the available information indicate that the test substance is corrosive. The test substance is skin corrosive and causes severe eye damage therefore testing for skin sensitization is not necessary.

With the OECD Toolbox (v4.1, 2018), no skin sensitisation potential is predicted for the target chemical, N,N-Dibutylformanide CAS 761-65-9; predicted from category members using read-across based on negative values from 5 nearest neighbours compared by prediction descriptors ( CAS no. 127-19-5, 68-12-2, 123-39-7, 60-35-5, 5343-44-2). Category members are single chemicals or mixtures and are selected based on the profile of the target chemical. Only chemicals having experimental data are listed in the category. The target chemical FALLS within applicability domain of the prediction.

Supportingly, the QSAR model OASIS TIMES (v2.27.19.13, 2018) also predicted no skin sensitisation potenial for TMG. However, the chemical is out of the interpolation structural space.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to REACH Regulation (EC) No 1907/2006 Annex VII section 8.3 column 2 the in vivo skin sensitization test is not necessary if the available information indicate that the test substance is corrosive. The test substance is skin corrosive and causes severe eye damage therefore testing for skin sensitization is not necessary. As there are no in vitro or in vivo data available and there was no structural alert for skin sensitisation, classification is not warranted.