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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid
- Physical state:liquid, viscous
- Analytical purity: 100% UVCB
- Lot/batch No.: Mischcharge aus G44/082/11 und G44/085/11

Test system

Vehicle:
unchanged (no vehicle)
Details on study design:
Each treatment group (test substance, NC and PC) consisted of 3 corneas.
750 μL of the undiluted test substance was applied directly to the epithelial surface of the cornea. Control tissues were concurrently applied into the anterior chamber with 750 μL of de-ionized water (negative control, NC) or with 750 μL of 1% (w/v) solution of sodium hydroxide in deionized
water (positive control, PC). The corneas were incubated in a horizontal position at about 32 °C for approximately 10 minutes (liquids and surfactants). The NC and PC were then removed from the anterior chamber using a syringe and the epithelium was washed at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red). Both chambers were then refilled with fresh Eagle’s MEM (without phenol red).
The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was measured spectrophotometrically. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.

CONTROLS
Negative control (NC): De-ionized water
Positive control (PC): Sodium hydroxide 1% (w/v) solution in de-ionized water for liquid test substances and surfactants

Results and discussion

Any other information on results incl. tables

Test substance

Mean Opacity Value

Mean Permeability Value

In Vitro irritancy Score

12/0027-1

2.9

0.002

2.9

NC

2.0

0.000

2.0

PC

120.2

3.963

179.7

Applicant's summary and conclusion