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EC number: - | CAS number: -
Mean laboratory historical control irritancy scores for the negative and positive controls were 0.5 and 152, respectively.
OBJECTIVE: The corneal irritation and damage potential of TFEE-5 (MTDID 21721, lot TFEE5-276/12/09-1) was tested in the Bovine Corneal Opacity and Permeability assay (BCOP).
METHODS: This study was conducted in compliance with the OECD GLP (1997). The study method was based on OECD 437 (2009), Background Review Document (BRD) prepared by ICCVAM and NICEATM (2006), INVITTOX (UK) protocol no. 124 SOP of Microbiological Associates Ltd. (1999) and Gautheron, P, et al (1992). TFEE-5 was tested as received. Bovine corneas (3 per group) were prepared in cMEM medium, supplemented with 1% FBS and 1% L-glutamine. The corneas were mounted in an O-ring holder and incubated for at least 1 hour at 32 C prior to exposure. Corneas (3 per group) were treated with 0.75 mL of TFEE-5, 10% benzalkonium chloride (positive control) or physiological saline (negative control) and incubated for a 10 minute exposure period at 32 C. At the end of the exposure period, the corneas were rinsed with media and they were then incubated for approximately 120 minutes. Opacity was evaluated prior to treatment and 120 minutes after the exposure period. Permeability was evaluated at 120 minutes after exposure using a fluorescein method. The mean in vitro irritation scores (IVIS) were calculated and a score greater than or equal to 55.1 indicates an ocular corrosive or severe ocular irritant.
RESULTS: The positive and negative controls were within the historical range which indicates the test was valid. The IVIS for TFEE-5 was 0.0.
CONCLUSION: Based on the results of this study, TFEE-5 is not considered an ocular irritant.
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