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EC number: 420-380-5
CAS number: 136465-81-1
The irritation potential to rabbit eye of Ro 31 -9373
(PTH-decahydroamide) was investigated using a standard protocol based on
OECD Test Guideline 405.
Ro 31 -9373 (PTH-decahydroamide) was instilled into the conjunctival sac
of three New Zealand White rabbits, as 81 mg of powder (weight
equivalent to the volume of 0.1 ml). The eyes were examined at 1, 24, 48
and 72 hours after dosing and then on day 7, and reactions scored using
the standard Draize assessment method.
Corneal opacity generally resolved by Day 3 having been noted in two of
the treated eyes. Iritis, also noted in two animals was slight in degree
but persisted through the 72 hour assessment and had resolved by Day 7.
Conjunctival irritation, redness and swelling, was observed in all three
treated eyes but was only moderate or marked in two animals. The degree
of response in these two rabbits was sufficient to require
classification as R36, Irritating to eyes.
Classification according to Commission Regulation (EC) No. 1272/2008
requires the Signal word "Warning", appropriate GHS pictogram and
classification as "Category 2: Eye irritant with the hazard statement
'H319: causes serious eye irritation'.
Precautionary statements P264 and P280 for prevention and P305 +P351
+P338 and P337 +P313 for response should be considered.
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