Registration Dossier

Administrative data

Description of key information

Skin irritation (Rat, GLP): non-irritant
[Bayer Schering Pharma AG, Report No. A49585, 2010-06-17]
Eye irritation (Rabbit, GLP): non-irritant
[Bayer Schering Pharma AG, Report No. A49728, 2010-06-16]

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

The single dermal administration of boldenone (ZK 5320) to male and female rats in the doses of 2000 mg/kg was tolerated without any local skin irritations. (Bayer Schering Pharma AG, Report No. A49585, 2010-06-17)

The single administration of boldenone (ZK 5320) to the right eye of male and female rabbits results in slight to severe transient irritation on the rabbit conjunctiva and slight to moderate hyperemia on the iris on day 1 and day 2 which decreased from day 3 onwards and were fully reversible on day 8 after administration. (Bayer Schering Pharma AG, Report No. A49728, 2010-06-16)

Justification for classification or non-classification

Boldenone (ZK 5320) was tested in one skin and one eye irritation test and did not show significant irritation potential.

Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.