Registration Dossier

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:

The skin sensitising potential of DMSO has been evaluated in humans, guinea pigs and mice using a wide range of methods.

Studies in Animals

DMSO did not induce skin sensitization in guinea pigs using the Buehler test (Marzulli and Maguire, 1982), the Magnusson and Kligman maximization method (Marzulli and Maguire, 1982; Nakamura et al., 1994) and the Draize test, the Cyclophophamide/CFA assay and the Split adjuvant test (Marzulli and Maguire, 1982). A mouse ear swelling test (Gad et al., 1986) and a mouse local lymph node assay (Ikarashi et al.,1993) were also negative.

Studies in Humans

No skin sensitization reaction was observed in 23 subjects after five 48-hour induction exposures to 75% DMSO solution (each one preceded by a 24-hour pre-treatment with 5% sodium lauryl sulphate) and challenge with 25% DMSO solution (Kligman, 1966).


Migrated from Short description of key information:
DMSO is not a skin sensitizer. Sensitization tests performed in guinea pigs and mice following methods comparable to the OECD guideline # 406 were uniformly negative. A skin sensitization assay performed in humans was also negative.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
There is no reported case of respiratory sensitization in humans.

Justification for classification or non-classification

Classification for skin and respiratory sensitisation is not warranted according to EU Directive 67/584/EEC and EU regulation (EC) No 1272/2008 (CLP).