Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin corrosion in vitro (3D-skin model with EST-1000, GLP, OECD TG 431 guideline draft, EU Method B.40): not corrosive
[Bayer AG, Report No. PH-34412, 2006-04-20]
Skin irritation in vivo (Rabbit-NZW, GLP, OECD TG 404, EU Method B.4): not irritating to the skin
[Bayer AG, Report No. PH-34402, 2006-04-10]
Eye irritation in vivo (Rabbit-NZW, GLP, OECD TG 405, EU Method B.5): not irritating to the eye
[Bayer AG, Report No. PH-34401, 2006-04-10]

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

In the skin corrosion test in vitro with reconstructed human epidermis EST-1000 no corrosive property of the test item could be determined.

In the skin irritation test in all 3 animals no signs of skin irritation could be observed. There were no systemic intolerance reactions.

In the eye irritation test all animals showed reddening of the conjunctivae 1 h after instillation, only 2 of them had slight irritation signs at the conjunctivae after 24 h. All effects were fully reversible within 2 days. There were no systemic intolerance reactions.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.