Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin Irritation :

In the supporting in vitro study one single sample of N-(2-Hydroxyethyl)-N-Methyl-p-Toluidine (MHPT) was evaluated with the Irritection Assay System in order to predict its potential demal irritation. The dermal results demonstrated that the sample was a dermal non-irritant.

 

MHPT was applied in an in vivo study undiluted for 4 hours to the shaved backs of three New Zealand White rabbits at a dose of 0.5 ml. All test sites were examined for signs of dermal irritation (i.e. edema, erythema and/or echar formation) and corrosivity at 30-60 minutes, 24, 48 and 72 hours and 7 and 14 days.

No signs of dermal corrosivity were observed at any time during the study.

The citeria for a classification for skin irritant cat. 2 are also not met:

- only one animal had a mean edema/erythema irritation score > 2.3

- no animal had signs of irritation at the end of the study (after 14 days)

Therfore the substance is not classified as skin irritant.

Eye irritation:

In the in vitro study one sample of MHPT was evaluated with the Irritection Assay System in order to predict its potential ocular irritation. The ocular results indicated that the sample of MHPT was a mild irritant.

In the second in vitro study MHPT showed effects on the cornea of the bovine eye. The calculated mean IVIS was 21.61.

Since both in vitro tests showed positive effects the substance is classified as eye irritant UN GHS Category 2.