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EC number: 278-780-9
CAS number: 77881-13-1
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]
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
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.
Based on the study results a classification
according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008
(CLP) is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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