Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in 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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: "GLUCOSE SYRUPS WHEAT HYDROLYZED".
Trade name: Dried wheat glucose syrup.
Batch No.: 5095187 [Production date : 24/08/2009]
Purity : 97.8 % dry solids
Appearance: White, slightly hygroscopic powder.
Solubility: Good soluble in water.
pH: neutral
Conditions of storage: Room temperature, no protection from light.
Stability at conditions of storage: Stable.
Expiry date: June 2011.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species, strain, sex: Rabbits, New Zealand White, males or females.
Supplier: Charles River Deutschland GmbH, D-88353 Kisslegg.
Body weight at administration : Approximately 2.0 – 2.2 kg.
Number of animals: 3 animals.
Hygiene: Optimal hygienic conditions.
Room temperature: Average of about 20 °C
Relative humidity: 30-70 %
Air exchange: 12 per hour.
Light: 12 hours light, 12 hours dark, only artificial light from 6 a.m. to 6 p.m.
Cages: Individual caging in terulan cages, Ehret GmbH, A-3430 Tulln, 65 cm x 65 cm bottom area, 50 cm height.
Feed: Ssniff K-H maintenance diet for rabbits (item V-2333-000), ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany.
Water: Tap water from an automatic watering system, ad libitum.
Environmental Enrichment: A raised resting area is integrated in the cages.
Acclimatisation: At least 5 days.
Identification: Individual labelling with felt-tipped pen in a pinna of an ear and cage labels.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL respectively its equivalent (maximum 100 mg) per animal
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3 animals
Details on study design:
Initial test:
First the test substance is administered to one animal only.
If a corrosive or severe irritant effect is observed, further testing for ocular irritancy will not be performed.

Confirmatory test:
If no corrosive or severe irritant effect is observed in the initial test, the test substance is administered to two additional animals about one week later.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h - 24 h - 48 h - 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h - 24 h - 48 h - 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 1 h - 24 h - 48 h - 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h - 24 h - 48 h - 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
GENERAL SIGNS OF TOXICITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

EYE EXAMINATIONS
- Corneae and irises: Not affected at any observation point.
- Conjunctivae: Not affected at any observation point

Applicant's summary and conclusion