Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation (Rat, GLP): not skin irritating
[Schering AG, Report No. X324 -draft-, 1998-11-05]
Eye irritation (Rabbit, GLP, OECD TG 405): not eye irritating
[Schering AG, Report No. X345 -draft-, 1999-02-02]

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 Enpivalat to male and female rats at the dose of 2000 mg/kg (application volume 0.4 - 0.6 ml; 439-587 mg/animal) was tolerated without any mortality or macroscopic pathological signs. Shortly after administration females showed some clinical signs such as hyperactivity, vocalization and spastic gait. No compound-related clinical signs were observed in females from 3 hours after administration onwards, males were without findings over the whole study period.

Although the study was with respect to skin irritation / corrosion not conducted according to current guidelines and with the most sensitive species rabbit Enpivalat 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 Enpivalat into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 47.3 -54.0 mg) results in slight to moderate reddening and slight swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) only slight conjunctival reddening was seen in three out of 4 animals and in 1 out of 4 animals on day 3. All animals were without findings on day 4 (72 hours after administration).

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, iris and conjuntival swelling and 0.3 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.