Registration Dossier

Administrative data

Description of key information

Skin corrosion in vitro (Epiderm): not corrosive
Skin irritation/corrosion in vivo: slightly irritating
Eye irritation in vitro (HET-CAM): no serious eye damage
Eye irritation in vivo: not irritating

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion:

In an in vitro skin corrosion test (EpiDerm Skin Corrosion Test) according to OECD guideline 431 in compliance with GLP the substance did not show a corrosive potential (BASF AG, 2008). In an in vivo skin irritation study in rabbits according to OECD guideline 404 in compliance with GLP the substance showed a mild skin irritation potential considering the described cutaneous reactions as well as the average score for irritation (BASF SE, 2009). The cutaneous reactions, with the exception of scaling in one animal, were reversible within 14 days after removal of the patch.

 

Eye irritation:

In an in vitro eye irritation test (HET-CAM test) that was performed in compliance with GLP the substance did not produce changes indicative for serious eye damage (BASF SE, 2008). In an in vivo eye irritation study in rabbits according to OECD guidleine 405 in compliance with GLP the substance did not show an eye irritation potential considering the described ocular reactions as well as the average score for irritation (BASF SE, 2009).

Respiratory irritation:

There are no data available concerning respiratory irritation.

Justification for classification or non-classification

GHS classification according to Annex I 1272/2008 CLP (EU GHS):

- Skin irritation/corrosion: conclusive, but not sufficient for classification

- Eye irritation: conclusive, but not sufficient for classification