Registration Dossier
Registration Dossier
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EC number: 849-290-8 | CAS number: 9001-97-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-09-2007 to 13-11-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted on 24 April 2002.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Active enzyme protein of 1,4-alpha-glucan branching enzyme (CAS no.9001-97-2 , EC name 1,4-alpha-glucan branching enzyme, Enzyme class no. 2.4.1.18)
- Molecular formula:
- n.a.
- IUPAC Name:
- Active enzyme protein of 1,4-alpha-glucan branching enzyme (CAS no.9001-97-2 , EC name 1,4-alpha-glucan branching enzyme, Enzyme class no. 2.4.1.18)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- - Lot/batch No.: PPY27209
- Expiration date of the lot/batch: June 2017
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF bred New Zealand White albino rabbits.
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: Males, young adult
- Weight at study initiation: 1966, 1936 and 2106 g
- Housing: Individually in stainless steel cages with perforated floor.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The chicken eye cornea was treated with 0.1 mL.
- Concentration (if solution): Undiluted test sample, 9.5% TOS. - Duration of treatment / exposure:
- After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: few seconds
SCORING SYSTEM: The acute irritation of the test sample was classified according to the EC criteria for the labelling and classification of dangerous substances, as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993 and to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1,4-alpha-glucan branching enzyme, batch PPY27209 was tested for acute eye irritating properties in an experiment with three albino rabbits. At 48 h after treatment, the eye effects had cleared completely.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993) 1,4-alpha-glucan branching enzyme, batch PPY27209 was not irritating to eyes. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 1,4-alpha-glucan branching enzyme, batch PPY27209 was also not irritating to eyes. - Executive summary:
1,4-alpha-glucan branching enzyme, batch PPY27209 was tested for acute eye irritating properties in an experiment with three albino rabbits, according to EC Directive 92/69/EC, method B.5 and OECD Guideline no. 405.
The test item caused slight redness of the conjunctivae at the 1 hour and 24 hours observations. At 48 h after treatment, all eye effects had cleared completely.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 1,4-alpha-glucan branching enzyme, batch PPY27209 was not irritating to (human) eyes.
According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 1,4-alpha-glucan branching enzyme, batch PPY27209 was also not irritating to (human) eyes.
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