Registration Dossier
Registration Dossier
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EC number: 204-445-3 | CAS number: 121-03-9
Endpoint summary
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.
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