Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 227-678-2 | CAS number: 5932-68-3
Table 7.3.2/1: Results of the BCOP assay
Opacity ± SD
Permeability ± SD
In vitro irritancy Score ± SD
18.667 ± 4.619
1.382 ± 0.349
39.4 ± 8.2
No prediction can be
16.667 ± 1.528
0.713 ± 0.240
27.4 ± 2.7
2.000 ± 0.000
0.015 ± 0.001
The positive control, ethanol, elicited an In Vitro Irritancy Score of 27.4. This value was within the historical range (mean ± 2 x SD = 25.5 – 50.3) for the assays performed to date.
The negative control, 0.9% sodium chloride solution, opacity mean change value was 2.0 which was below the maximum acceptance value of 3.0. The permeability mean of the negative control was 0.015, which was below the maximum acceptance value of 0.1.
An in vitro eye irritation study was performed according to the OECD Guideline 437 and in compliance with GLP to assess the corneal damage potential of test substance by means of the BCOP assay using fresh bovine cornea. 750 µL of test item was applied to cornea for 10 minutes followed by an incubation period of 2 hours at 32 ± 1 °C and corneal opacity was measured. Three corneas were used for each treated series (undiluted test item; negative control; positive control: ethanol). Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. Two endpoints, corneal opacity and permeability, were measured and combined to give an In Vitro Irritancy Score. Following treatment with test substance, the corneas were noted as clear. The corneas treated with the positive control, ethanol, were opaque and the corneas, treated with the negative control, 0.9% sodium chloride solution, were clear. It was noted during the post opacity measurement that cornea number 1, treated with the negative control, 0.9% sodium chloride solution, had an opaque line in the centre of the cornea. As cornea no. 1 was visibly damaged the opacity and permeability results were not included in the calculation of the mean In Vitro Irritancy Score for test substance and the positive control ethanol. The negative and positive controls met the acceptance criteria for this assay. The calculated mean in vitro irritancy score for test substance and positive control were 39.4 ± 8.2 and 27.4 ± 2.7, respectively.
With an IVIS of 39.4, no prediction can be made as the result is outside the decision criteria (i.e.≤3 or >55)
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again