Registration Dossier

Administrative data

Description of key information

Skin irritation (Rat): not skin irritating
[Schering AG, Report -drat-, 1994-10-19]
Eye irritation (Rabbit, euivalent to OECD TG 405): not eye irritating
[Schering AG, Report No. X009 -draft-, 1995-07-12]

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 6 -Chlor-Chlormethyldien (ZK 10882) to male and female rats at the dose of 2000 mg/kg (corresponding to 206-228 mg ZK 10882/male animal and 196-210 mg ZK 10882/female animal) 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 6 -Chlor-Chlormethyldien 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 6 -Chlor-Chlormethyldien (ZK 10882) into the right eye of four female rabbits with a volume of 0.1 ml/eye (corresponding to 71.5 -76.5 mg) results in slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids in all animals on administration day. Afterwards slight to moderate conjunctival reddening (in all animals) and slight swelling (in two animals) were seen up to 24 hours after application . All animals were without findings 48 hours after application.

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, 0.17 for conjuntival swelling and 0.42 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.