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: -
CAS number: -
Evaluation of ocular irritation is part of the Human Health Hazard
Assessment required for registration of a chemical. In this study, the
irritation potential of EXP0700332 was assessed using the HCE® in vitro
ocular irritation test.
Prior to the conduct of the irritation assay, a preliminary test was
conducted to assess the intrinsic ability of the test item to reduce
methylthiazoldiphenyl-tetrazolium bromide (MTT) to formazan, which is a
measure of cell viability in the assay. The results of the MTT direct
reduction test showed that EXP0700332 did not reduce MTT to formazan.
Eye irritation potential was assessed by applying EXP0700332 (30 µL) to
the exposed surface of three HCE tissues for 60 minutes. The surface
area of the HCE was 0.5 cm2, therefore the application rate was 60
µL/cm^2. After the 60 minutes exposure period, the test item was washed
from the surface of the HCE using Dulbecco’s phosphate-buffered saline
(PBS; 25 mL) and cotton swabs. The HCE tissues were then incubated for a
recovery period of 16 hours in a humidified incubator set to maintain
temperature and CO2 levels of 37 degrees Celsius and 5%, respectively.
Following incubation, the HCE tissues were transferred to maintenance
medium containing MTT (0.5 mg/mL) and returned to the incubator for 3
hours. The HCE tissues were then transferred to isopropanol in order to
extract the formazan. After extraction (90 minutes), the formazan
production (cell viability) was assessed by measuring the optical
density of the extracts at a wavelength of 550 nm. Three replicates of
the positive control,
Triton X-100 solution (20%, w/v), and the negative control, PBS, were
tested in parallel to demonstrate the efficacy of the assay. The
viability of each individual HCE tissue was calculated as a percentage
of the mean negative control viability (defined as 100%).
Exposure to EXP0700332 resulted in a mean HCE® viability of 100.81 +/-
7.23% of the negative control value. Exposure to the positive control,
Triton X-100 (20%, w/v), resulted in a mean HCE® viability of 0.23 +/-
0.11% of the negative control value. Cell viability values below a
threshold of 50% of the negative control viability indicate that the
test item is irritant.
In conclusion, EXP0700332 was demonstrated to be non-irritant to eyes
when tested in vitro using the HCE® reconstructed human corneal model.
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.
Do not show this message again