Registration Dossier
Registration Dossier
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EC number: 931-687-3 | CAS number: -
Eye irritation
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:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Syrups, wheat, hydrolyzed starch
- EC Number:
- 931-687-3
- Molecular formula:
- not applicable
- IUPAC Name:
- Syrups, wheat, hydrolyzed starch
- 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.
Constituent 1
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
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.
