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EC number: 200-073-0
CAS number: 50-97-5
Table 2. Result and Discussion
No. of Animals
Redness, chemosis, discharge
Test article residue in conjunctival sac
Diminished fecal output and feed consumption were observed.
Because transient inappetence is frequently observed in rabbits and other animals following administration of Buprenorphine, and the animal appeared otherwise normal and maintained body weight throughout the study, there is no evidence that this finding is test article-related.
Two animals’ body weights remained the same. One animal gained weight by study termination.
OECD 405:Ocular Irritant
US EPA:Category III
OECD 405 - 2016: Three healthy New Zealand White rabbits (two males and
one female), free from evidence of ocular irritation and corneal
abnormalities, were placed on the study. An analgesic, Buprenorphine,
was administered at 0.1 mg/kg subcutaneously between the shoulder blades
approximately one hour prior to instillation of the test article. A dose
of 0.1 ml equivalent (36 mg) of the test item was placed into the
conjunctival sac of one eye of each rabbit. The eyes were examined
pre-test and scored by the Draize technique at 1, 24, 48 and 72 hours
post-instillation. The control eyes were observed at the same time
periods. Sodium fluorescein dye procedures were used at the 24-hour
observation interval. Animals were evaluated for mortality, toxicity and
pharmacological effects twice daily. Body weights were recorded pre-test
and at termination.
Diminished fecal output and feed consumption were observed. Because
transient inappetence is frequently observed in rabbits and other
animals following administration of Buprenorphine, and the animal
appeared otherwise normal and maintained body weight throughout the
study, there is no evidence that this finding is test article-related.
Two animals’ body weights remained the same. One animal gained weight by
study termination. No evidence of corrosively or irritation was observed.
Under the condition of the study the test item did not produce any
evidence of ocular irritation or corrosivity and therefore does not
meet the criteria for classification according to the Globally
Harmonized Classification System and to the Regulation (EC) No.
1272/2008, relating to the Classification, Labelling and Packaging of
Substances and Mixture.
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