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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

- no skin sensitisation study is warranted due to skin corrosivity of the substance

- predicetd value (OECD Toolbox, OASIS TIMES): not skin sensitising

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

According to Column 2 of REACH Annex VII a skin sensitisation study (required in Section 8.3 of REACH Annex VII) does not need to be conducted if 1) the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes, or 2) the substance is a strong acid or base, or 3) the substance is flammable in air at room temperature. As the test substance is a strong base (pH > 11.5) and meets the classification criteria both for Skin corr. 1B, H314 and Flam. Liquid 3 according to Regulation EC 1272/2008, no skin sensitisation study is needed to fulfill the data requirements defined in REACH Annex VII.

Prediction of Skin Sensitisation for 1,1,3,3-tetramethylguanidine

With the OECD Toolbox (v3.3.0.152, 2017), no skin sensitisation potential is predicted for the target chemical TMG, CAS 80 -70 -6; predicted from category members using read-across based on negative values from 4 nearest neighbours compared by prediction descriptors ( CAS no. 15894-70-9, 461-58-5, 102-06-7, 97-39-2). 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. The data used for calculating the current prediction is taken from 9 experimental values selected from the following database(s): 1. ECHA CHEM, 2. Skin Sensitization.

Supportingly, the QSAR model OASIS TIMES (v2.27.19.13, 2017) also predicted no skin sensitisation potenial for TMG. However, the chemical is out of the interpolation structural space.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Due to the negative prediction for skin sensitisation by the QSAR models OECD Toolbox and OASIS TIMES, no classification for skin sensitisation is justified according to CLP ((EC) 1272/2008).