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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitising

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a Murine Local Lymph Node Assay (LLNA) according to OECD 429, 4 -Nitrotoluene-2 -sulphonic acid shows a skin sensitizing effect. No signs of systemic toxicity were noticed (BASF SE, 2010).

When applied as 40% preparation in propylene glycol, the test substance induced a biologically relevant response (increase to 1.5 fold or above of control value = stimulation Index (SI) >=1.5) in the auricular lymph node cell counts. There was a relevant increase in lymph node weights, as well.Concomitantly, the increase of ³H-thymidine incorporation into the cells was biologically relevant (increase above the cut off stimulation index of 3) at this concentration.

The test-substance preparations did not cause any increase in ear weights.

4-Nitrotoluene-2-sulphonic acid showed a skin sensitizing effect in the Murine Local Lymph Node Assay.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The LLNA study is used for the evaluation for the classification as a skin sensitiser.

During the LLNA a Simulation Index (SI) of 4.47, and therefore above 3, was observed at the concentration 40 % of test substance in propylene glycol.

EC3 is therefore extrapolated to be 40 % and therefore > 2 %. For this reason the substance is classified in Categori 1B for skin sensitisation (H317) according to the CLP Regulation EC No.1272/2008.