Registration Dossier

Administrative data

Description of key information

In the dermal in vivo study, severe erythema (score of 4) and very slight to slight edema (scores of 1 or 2) were noted at the 3-minute, 1-hour and 4-hour treated dose sites. Brown discoloration and blanching were evident at the 1- and 4- hour sites. The area outside of the 4-hour dose site also appeared to have destruction of the top skin layer.  Based on this study in one animal, the test material was considered to be corrosive.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the dermal in vivo study, severe erythema (score of 4) and very slight to slight edema (scores of 1 or 2) were noted at the 3-minute, 1-hour and 4-hour treated dose sites. Brown discoloration and blanching were evident at the 1- and 4- hour sites. The area outside of the 4-hour dose site also appeared to have destruction of the top skin layer. Based on this study in one animal, the test material was considered to be corrosive.


Justification for selection of skin irritation / corrosion endpoint:
In an in vivo study, paraformaldehyde, oligomeric reaction products with 4-tert-butylphenol, m-phenylenebis(methylamine) (Mannich Base PTBP-MXDA) caused corrosion at the 4-hour exposure site for the 30-60 minute scoring interval.

Justification for selection of eye irritation endpoint:
Due to skin corrosivity result, eye irritation study was not conducted.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification