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EC number: 680-378-7
CAS number: 138624-11-0
AS = Abraded Skin / IS = Intact Skin
Based upon the weight of evidence from dermal, ocular and oesophageal
irrritancy studies it is concluded that the substance will be a
In vivo studies conducted with the source substance, sodium alendronate,
resulted in severe irreversible skin irritation (erythema with
concommitent scaling) 14 days post dosing ; in conjunction with the pH
of the target substance (pH 2.1) this was considered sufficient to
classify the substance as Skin corrosive 1C.
Ocular studies conducted in NZW rabbbits resulted in premature
termination of the study on humane grounds following extreme chemosis at
the 48hr timepoint; the substance is considered to be classified as
Severe Eye Damage 1.
Oesophageal irritancy studies conducted in dogs resulted in ulcerative
damage following 4 weekly doses of the substance; this has been
considered to be a surrogate tissue for the respiratory tract mucosa and
classification as a respiratory irritant is justified.
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