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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation key study

The result from a fully reliable study (Bernard 2012) conducted according to OECD TG 429 using 25 %, 50 % and 100 % of the test item shows that 4-phenylbutan-2-one has no sensitising potential.

Supporting information

In a patch-test with humans (Ishihara 1978) it was shown that there was no pre-existing skin sensitisation to 4-phenylbutan-2-one in dermatologic patients.

Migrated from Short description of key information:

4-phenylbutan-2-one does not show an allergenic potential when tested up to the concentration of 100%.

Justification for selection of skin sensitisation endpoint:

GLP study according to OECD TG 429 (Skin sensitisation: Local Lymph Node Assay).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Migrated from Short description of key information:

not required

Justification for classification or non-classification

- skin sensitisation:

Based on the above stated assessment of the skin sensitisation potential, 4-phenylbutan-2-one does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.