Registration Dossier

Administrative data

Description of key information

Skin irritation:
3 studies (1 key study/2 supporting studies) available: mildly/not irritating
Eye irritation:
1 study available: minimally transient irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Three studies are available that examined the skin irritancy potential of Methylparaben. For two of them only basic facts are reported but one detailed study clearly demonstrates that the skin irritation potential is minimal to negligible. This conclusion is consistently supported by the other studies which did not show any skin irritation after Methylparaben treatment in humans and rabbits.

There is limited data available on the eye irritancy potential. The study was performed according to the Eye Irritation Test Design (modified Draize) and reported in sufficient detail to be able to ascertain that the substance has very low eye irritancy potential (irritation score 1/110, 6 animals), with effects disappearing within 48 hours of instillation of the substance into rabbit eyes.

Justification for classification or non-classification

The substance is not irritating to the skin following single application and does not meet the criteria for classification as a skin irritant.

There is limited but sufficient data available on the eye irritancy potential to conclude that the substance does not meet the criteria to be classified as irritating to the eye.

It can reasonably be deduced that Methylparaben ether does not cause respiratory tract irritation and thus does not have to be classified, because the substance did cause only slight, fully reversible irritative effects in the eyes and the skin. It does not have to be classified as either skin or eye irritating. Therefore, Methylparaben, in the unlikely event of being inhaled as a dust, is considered not to cause severe effects, due to its not- irritating properties on skin and eye. A harmful interaction with living cells and tissues is very unlikely (as demonstrated by the in vivo skin and eye irritation studies).