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EC number: 232-894-5 | CAS number: 9033-35-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1999-02-15 to 1999-05-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Since the two enzymes are from the same enzyme sub-sublcass, similar results can be expected for pectin lyase.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC
- Version / remarks:
- EEC (1992). Acute Toxicity (Eye irritation). Section B5 (L383A/127-L383A/130) of the Annex to
the European Communities Commision Directive 92/69/EEC. The Official Journal of the European
Communities L.383A ( Vol. 35), 29 December 1992 (ISBN 0378-6978). - Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lyase, pectate
- EC Number:
- 232-766-9
- EC Name:
- Lyase, pectate
- Cas Number:
- 9015-75-2
- Molecular formula:
- Not available
- IUPAC Name:
- Pectate lyase IUBMB 4.2.2.2
- 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.
- 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.
- 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.
- 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.: PPE 6345
- Expiration date of the lot/batch: 2008-11-30
- Stability under test conditions: Stability at ambient temperature >4 hours
- Storage condition of test material: Stored below minus 18 degrees of C in the dark.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Danish Landrace, albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Statens Seruminstitut "Hvidesten", Denmark
- Weight at study initiation: between 2.14 - 2.56 kg
- Age at study initiation: Young adults
- Housing: Individually, in animal room with control of temperature (20±3°C) and humidity (30-70%)
- Diet: 110 g standard diet per day (Altromin 2110, Standard diet for rabbits) ad libitum
- Water: Tap water ad libitum
- Acclimation period: 14 days
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES:
From: 1999-02-22 To: 1999-03-12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Test batch used as is.
- Amount(s) applied (volume or weight with unit): 0.1 mL into the left eye - Duration of treatment / exposure:
- The test material was applied to the conjunctival sac. The lids were gently held together for approximately 1 second. The untreated eye served as a control.
- Observation period (in vivo):
- The reactions were judged 1, 24, 48 and 72 hours after instillation of the test material.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not specified
SCORING SYSTEM: The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the guideline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #2, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: Tear secretion
- Basis:
- animal: #2, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Conjunctival reaction (redness, score 1) was observed in two rabbits at the 1 hour reading and in one rabbit at the 24 hour reading. Chemosis (score 1) was observed at the 1 hour reading in two animals. All signs were reversible, and no reactions were seen after 48 or 72 hours. The rabbits showed no signs of systemic reaction to the treatment.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Slight conjunctival reaction and chemosis were observed earlier on. However, all signs were reversible, and no reactions were seen after 48 or 72 hours. The rabbits showed no signs of systemic reaction to the treatment.
In conclusion, pectate lyase can be classified as a ‘non irritant’ to the eye. - Executive summary:
In accordance with the OECD guideline 405, a test for eye irritation in rabbits was performed with pectate lyase, batch PPE 6345.
The eyes of three animals were checked for irritation before instillation and only healthy animals were used. 0.5 mL of pectate lyase, batch PPE 6345 was placed in the conjunctival sac of the left eye by pulling the lower eyelid away from the eyeball. The lids were gently held together for about one second after instillation. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the specified guideline.
No corneal opacity, iris reactions or tear secretion were noted at any time during the test. Conjunctival reaction (redness, score 1) was observed in two rabbits at the 1 hour reading and in one rabbit at the 24 hour reading. Chemosis (score 1) was observed at the 1 hour reading in two animals. All signs were reversible, and no reactions were seen after 48 or 72 hours. The rabbits showed no signs of systemic reaction to the treatment.
In conclusion, pectate lyase can be classified as a 'non-irritant' to the rabbit eye.
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