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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

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:
Wheat, ext., hydrolyzed
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

Applicant's summary and conclusion