Registration Dossier

Administrative data

Description of key information

Skin irritation (Rabbit, GLP, comparable to OECD TG 404): not skin irritating
[Schering AG, Report No. 6482, 1985-03-08]
Eye irritation (Rabbit, GLP, comparable to OECD TG 405): not eye irritating
[Schering AG, Report No. 6512, 1985-03-20]
Eye irritation (Rabbit, GLP, comparable to OECD TG 405): not eye irritating
[Schering AG, Report No. 6510, 1985-03-28]

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 0.5 g AD-Cyanhydrin (ZK 74.804) to male and female rabbits for an exposure period of 4 h was tolerated without any incompatibility reaction. Therefore, according to EU classification criteria the substance is not skin irritating.

In one eye irritation study the single administration of AD-Cyanhydrin into the right eye of 2 male and 2 female rabbits with a volume of 100 mg/eye resulted in moderate local incompatibility reactions on the conjunctiva (including concjunctiva tertia andsclera) such as reddening, swelling and vessel injections and slight vessel injections of the iris, eyelid closure, slight secretion and reddening of the skin of the eyelid on the application day. All findings were transient with decreasing intensity from day 2 onwards and all animals were without findings on day 4.

The above mentioned findings were classified at that time as moderate local incompatibility reactions but 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, 0.3 for the iris and conjuntival swelling and 0.6 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating. However, it has to be mentioned that due to the low bulk density of the test substance the application volume was too big and a considerable amount of the test substance was lost after application. The remaining substance on the conjunctiva stuck together forming lumps of various size. Therefore, it was assumed that the observed findings were provoked by the physical characteristics of the compound and it was decided to perform another study using 10 mg test substance/eye only.

In a second study the single administration of AD-Cyanhydrin into the right eye of 1 male and 2 female rabbits with a volume of 10 mg/eye without rinsing the eyes resulted in slight transient local incompatibility reactions (after application slight reddening and vessel injections of the conjunctivae in all treated eyes, slight transient swelling of the conjunctiva in two animals and incomplete eyelid closure and reddening of the eyelid in one animal). All animals were without findings from day 3 onwards. The findings were assumed to be provoked by the physical characteristic of the compound (forming lumps in contact with lacrimal fluid). No substance related findings were observed in additional 6 animals where the eyes were rinsed after an exposure time of 4 or 30 seconds, respectively. Slight local incompatibility reactions such as reddenings and vessel injections were due to the rinsing procedure and were seen in the same intensity, frequency and duration also in the respective control eyes.

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 (for animals without rinsing the eyes) were 0 for the cornea, iris, 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.