Registration Dossier

Administrative data

Description of key information

Skin:
4-MHHPA is, based on the available information (erythema score 2.00, oedema score 2.25), not a dermal irritant according to CLP (1272/2008/EEC).
In addition, the substance is also not classified according to ANNEX VI table 3.1 (GHS) and table 3.2 (DSD) of Regulation (EC) No 1272/2008 with regard to skin irritation.
The conditions of the available study are more stringed, in particular the 24 hour exposure period compared with 4 hours of current test methods (described in OECD TG 404), and are thus regarded as worst case scenario. In conclusion the substance is not classified skin irritating based on DSD and CLP.
Eye:
Eye: Highly irritating and classified as Seriously eye damaging according to CLP (1272/2008/EEC) and 67/548/EEC when 0.1 mL is applied to the rabbit eye.

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:
adverse effect observed (irritating)

Additional information

Skin:

In a primary dermal irritation study, rabbits were dermally exposed to 0.5 mL of 4 -MHHPA for 24 hours. Reaction was assessed after 24 and 72 hours and assigned a numerical score according to the Draize scale. A mean erythema score (24 - 72 hours),calculated over all 6 animals, for intact skin of 2.00 and for abraded skin of 2.33 was observed. The oedema score was determined to be 2.25 for intact skin and 2.67 for abraded skin. Taking the test conditions into account, in particular the 24 hour exposure period compared with 4 hours of current test methods described in OECD TG 404, 4 -MHHPA has not to be classified and labelled as dermal irritant according to CLP (1272/2008/EEC), and according to 67/548/EEC (DSD).

Eye:

MHHPA is classified as seriously eye damaging and CLP (1272/2008/EEC) cites the need for hazard statement H318 (causes serious eye damage). Testing is waived based on the existing classification.


Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin:

Based on the results of the available skin irritation study, the substance was not classified and labelled according to Regulation 1272/2008/EC (CLP) and Directive 67/548/EEC (DSD).

Eye:

The substance is classified by Regulation 1272/2008/EEC which cites the need for hazard statement H318 (causes serious eye damage). The substance is also classified as seriously eye damaging (Xi, R41) according to 67/548/EEC.