Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation (Rat, GLP): not skin irritating
[Schering AG, Report No. X318 -draft-, 1998-10-15]
Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritating
[Schering AG, Report No. X360 -draft-, 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

The single dermal administration of Bromepoxid to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.

Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit Bromepoxid can be regarded as not irritating to the skin since 24 h exposure to the test substance (instead of 4 h) was tolerated by 6 rats (instead of 3 animals) without any local skin reactions.

The single administration of Bromepoxid into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 43.3 -44.2 mg) results in slight to moderate reddening and swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) only slight conjunctival reddening was seen in two out of four animals and from day 3 onwards, all animals were without findings.

According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea and iris and conjuntival swelling and 0.2 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

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.