Wheat, ext., hydrolyzed

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 437

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Wheat, ext., hydrolyzed

EC Number:

309-358-5

EC Name:

Wheat, ext., hydrolyzed

Cas Number:

100209-50-5

Molecular formula:

UVCB substance, not applicable.

IUPAC Name:

(2R,3S,4S,5R)-2,5-bis(hydroxymethyl)oxolane-2,3,4-triol; (2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-{[(2R,3S,4R,5R)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy}oxane-3,4,5-triol; (3R,4S,5S,6R)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol; 2-hydroxypropanoic acid; acetic acid

Details on test material:

Identification: Wheat Solubles, Hydrolyzed
Description: Light brown-yellow powder with lumps
Batch: Cargill WSH Batch A
Purity : treated as 100% pure
Stability under storage conditions Stable

Test animals / tissue source

Species:

other: Bovine cornea

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Test System: Bovine eyes were used as soon as possible after slaughter on the same day.

Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, ‘s Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.

Transport: Eyes were collected and transported in physiological saline in a suitable container.

Test system

Vehicle:

water

Controls:

yes

Amount / concentration applied:

The test substance was applied as a 20% (w/w) solution (750 microliter) directly on top of the corneas.

Duration of treatment / exposure:

240 minutes

Observation period (in vivo):

none

Number of animals or in vitro replicates:

3 corneas per treatment.

Details on study design:

The possible ocular irritancy of Wheat Solubles, Hydrolyzed was tested through topical application for 240 ± 10 minutes.

The study procedures described in this report were based on the most recent OECD guideline.

The test substance was applied as a 20% (wlw) solution (750 microliter) directly on top of the corneas.

Results and discussion

In vivo

Results

Irritation parameter:

other: not applicable

Irritant / corrosive response data:

The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas.

The mean in vitro irritancy score of the positive control (20% w/w Imidazole) was 126 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

Wheat Solubles, Hydrolyzed did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.0 after 240 minutes of treatment.

Any other information on results incl. tables

Treatment	Mean Opacity	Mean Permeability	Mean In vitro Irritation Score
Negative control	0	0.000	0
Positive control	79	3.122	126
Wheat Solubles, Hydrolyzed	1	0.003	1.00