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: 947-796-4 | CAS number: -
Interpretation of the results:
- Determination of the In vitro irritancy score (IVIS):
The mean opacity and mean permeability values (OD492) were used for each treatment group to calculate an in vitro score.
- The IVIS cut-off values for identifying the test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given hereafter:
< or = 3: no category,
>3 and < or = to 55: no prediction can be made,
> 55: category 1.
Based on the study results, the test substance was determined to be non-irritant to the eye.
An in vitro study was conducted to determine the eye corrosion potential of the test substance, 'mono- and di- C16 PSE, K+ and C16-18-OH', using the Bovine Corneal Opacity and Permeability (BCOP) method, according to OECD Guideline 437, in compliance with GLP. Preparation, selection and opacity reading of the corneas were performed as per guideline. Prepared corneas in triplicates were treated with each, test substance (20% w/v in sodium chloride 0.9% w/v), negative control (Sodium chloride 0.9% w/v) and positive control (20% w/v Imidazole solution in sodium chloride 0.9% w/v) substances at 32 ± 1ºC for 240 minutes. At the end of the exposure period the test substance and control substances were removed from the anterior chamber and the cornea was rinsed three times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. A post treatment opacity reading was taken and each cornea was visually observed. Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (5 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1ºC for 90 minutes. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The corneas treated with the test substance and the negative controls were clear post treatment where as the one treated with the positive control was cloudy. The positive control group had an overall IVIS of 96.9. The negative control gave opacity of ≤2.4 and permeability ≤0.072, the negative control acceptance criteria were therefore satisfied. The test substance IVIS score obtained was 0.7, which was well below the threshold for non-classification. The study has met the validity criteria. Under the study conditions, the test substance was determined to be non-irritating or non-corrosive to the eye (Harlan, 2014).
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