Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Only 2 studies are referenced in this section, but these studies (Van der Walle et al., 1982 a and b) hadn't the objective of determine if PMP is or not sensitising, the purpose was to show the concomitant sensitisation to hydroquinone and PMP, inhibitors in acrylic monomers.

The 2 studies were carried out on female guinea pigs.

The first one used the method of Guinea Pig Maximization Test, 10 animals, 2 semi occlusive epicutaneous induction with 0.5 then 1 M of PMP, and 2 challenges but no data on concentrations. This test led to a moderate sensitization; 5 animals / 10 showing a reaction (but no data on effect type).

The second one used the method of Freund's complete adjuvant test, 8 animals, 5 intradermal injections of 0.5M PMP as induction and 2 challenges but no data on concentrations. This test led to a moderate sensitization; 4 animals / 8 showing a reaction (but no data on effect type).

Based on these two studies, it is difficult to conclude, too much data are missing. PMP is however officially classified as R43 according to the EU CLP Regulation (EC) n°1272/2008, Annex VI table 3.2 and as Skin sensitizer Category 1 according to the Regulation (EC) n°1272/2008, Annex VI table 3.1.


Migrated from Short description of key information:
PMP is officially classified as R43 according to the EU CLP Regulation (EC) n°1272/2008, Annex VI table 3.2 and as Skin sensitizer Category 1
according to the Regulation (EC) n°1272/2008, Annex VI table 3.1.

Justification for selection of skin sensitisation endpoint:
PMP is officially classified as Skin sensitizer Category 1 according to the Regulation (EC) n°1272/2008, Annex VI table 3.1, and published data selectes as weight of evidence showed positive reactions.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the 2 available studies, no conclusion can be drawn. However, PMP is officially classified as R43 according to the EU CLP Regulation (EC) n°1272/2008, Annex VI table 3.2 and as Skin sensitizer Category 1 according to the Regulation (EC) n°1272/2008, Annex VI table 3.1.