Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Dermal local tolerance (Rat, GLP, not audited report; OECD 402): not irritant
[Schering AG, Report X296; 1998-09-24]
Occular local tolerance (Rabbit, GLP, not audited report; OECD 405): not irritant acc. EU criteria
[Schering AG, Report X362; 1999-07-21]

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

After single dermal administration of ZK 5180 to 3 male and 3 female rats at a dose of 570 -594 mg/male rat and 436 -448 mg/female rat of the original compound, no compound related local findings were observed after removing of the bandages at the time points 1, 24, 48 and 72 hours. [Schering AG, Report X296; 1998-09-24]

After single administration of ZK 5180 into the conjuctival sac of the rabbit eye (2 male; 2 female rabbits) slight to moderate reddening and slight to severe swelling of the conjuctivae were observed in all animals on the application day, which was fully reversible by day 3 after administration. [Schering AG, Report X362; 1999-07-21]


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

There is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).