p-[(2-chloroethyl)ethylamino]benzaldehyde

Endpoint summary

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 according to OECD Guideline 429 in compliance with GLP N-Chloroethyl,N-Ethyl-4-Aminobenzaldehyd showed a skin sensitising effect (BASF SE, 2010).

No signs of systemic toxicity were noticed. When applied as 0.3% and 1% preparations in MEK, the test substance induced a response (increase to 1.5-fold or above of control value = stimulation index (SI)≥1.5) in the auricular lymph node cell counts at the border of biological relevance. In addition there was a slight increase in lymph node weights. The increase of ³H-thymidine incorporation into the cells was biologically relevant (increase above the cut off stimulation index of 3) at the concentration of 1%. The 0.3% test-substance preparation caused an increase of ³H-thymidine incorporation into the cells, which failed the cut off stimulation index of 3 and thus lies below the threshold of immunologic relevance. The increase in ³H-thymidine incorporation was concentration dependent. The 1% test-substance preparation caused some increase in ear weights as a sign of minimal ear skin irritation. Due to the biological relevant increases in lymph node cell counts and concentrationresponse relationship in ³H-thymidine incorporation without the presence of distinct ear skin reaction, the results indicate that a skin sensitization potential of the test substance cannot be excluded. Thus it is concluded that N-Chloroethyl,N-Ethyl-4-Aminobenzaldehyd shows a skin sensitising effect in the Murine Local Lymph Node Assay under the test conditions chosen.

The threshold concentration for sensitization induction was > 0.1% < 1% (> 0.1% < 0.3% for the cell count SIs; slightly below 1% for the ³H-thymidine incorporation SIs). The estimated concentration that leads to the SI of 1.5 for cell count (EC 1.5) and the estimated concentration that leads to the SI of 3.0 for³H-thymidine incorporation (EC 3) were calculated by linear regression from the results of the 0.1% and 0.3% concentrations (cell count SIs) or of the 0.3% and 1% concentrations (³H-thymidine incorporation SIs) to be 0.3% or 0.8%, respectively.

Migrated from Short description of key information:
LLNA (mouse): Sensitising to the skin (EC 1.5 approx. 0.3%, EC 3 approx. 0.8%)

Respiratory sensitisation

Endpoint conclusion

Additional information:

Migrated from Short description of key information:
There are no data available concerning respiratory sensitisation.

Justification for classification or non-classification

EU classification according to Annex VI of the Directive 67/548/EEC:

- Sensitising to the skin, R43

GHS classification according to 2nd ATP to 1272/2008 CLP (EU GHS):

- Skin sensitisation Category 1A