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EC number: 232-668-6 | CAS number: 9003-99-0
- 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 1996-04-19 to 1996-07-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD 405, (1987)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Peroxidase
- EC Number:
- 232-668-6
- EC Name:
- Peroxidase
- Cas Number:
- 9003-99-0
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- Peroxidase IUBMB 1.11.1.7
- 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:
- solid: particulate/powder
- Details on test material:
- - Lot/batch No.: PPX 5156
- Expiration date of the lot/batch: At least 2005.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novo Nordisk A/S
- Age at study initiation: 19 weeks
- Weight at study initiation: 2.6-2.7 kg
- Housing: Individually in plastic cages with mesh floor
- Diet: 130 g standard diet per day
- Water: Tap water ad libitum
- Acclimation period: 6-7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
IN-LIFE DATES: From: 1996-04-29 To: 1996-05-03
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Test batch used as is:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g enzyme concentrate dry matter into the left eye - Duration of treatment / exposure:
- The test material was applied to the conjunctival sac.
- 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 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the guideline.
Grading of Ocular Lesions:
CORNEA
Opacity : Degree of density (area most dense taken for reading)
No ulceration or opacity ...................................................................................................... 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster,
details of iris clearly visible) ................................................................................................ 1
Easily discernible translucent areas, details of iris slightly obscured ..................................2
Nacreous areas, no details of iris visible, size of pupil barely discernible ...........................3
Opaque cornea, iris not discernible through the opacity ......................................................4
IRIS
Normal ...................................................................................................................................0
Markedly deepened rugae, congestion, swelling, moderate circum corneal hyperaemia,
or injection, any of these or any combination thereof, iris still reacting to light (sluggish
reaction is positive) ...............................................................................................................1
No reaction to light, hemorrhage, gross destruction (any or all of these) .............................2
CONJUNCTIVAE
Redness : (Refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Blood vessels normal .............................................................................................................0
Some blood vessels definitely hyperemic (injected) ..............................................................1
Diffuse, crimson colour, individual vessels not easily discernible .........................................2
Diffuse beefy red ...................................................................................................................3
Chemosis : Lids and/or nictating membranes
No swelling .............................................................................................................................0
Any swelling above normal (includes nictating membranes) .................................................1
Obvious swelling with partial eversion of lids ........................................................................2
Swelling with lids about half closed .......................................................................................3
Swelling with lids more than half closed ................................................................................4
Flourescein 2% w/w was used, if there were signs of corneal opacity/ulcerations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal reactions, no iris reactions were observed in any of the animals at the 1-, 24-, 48- and 72-hour reading.
Animal no. 4 showed conjunctival redness at the readings 1, 24 and 48 hours after test substance application. Rabbits no. 4 and 7 showed similar reactions at 1 and 24 hours after application. The scores were 1 in all situations. However, this was fully reversible after 72 hours.
The rabbits showed no sign of systemic reaction to the treatment. The weight of the animals was not influenced by the treatment - Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The instillation of 0.1 g enzyme concentrate dry matter to the conjunctival sac of 3 rabbits caused no signs of eye irritation, and under the test conditions peroxidase is not to be classified and can be considered as 'non irritant'.
- Executive summary:
In accordance with the OECD guideline 405, a test for eye irritation in rabbits was performed with Peroxidase, batch PPX 5156. The eyes of three animals were checked for defects or irritation before instillation and only animals without defects were used.
0.1 g enzyme concentrate dry matter 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 redness was observed after 24 hours in all three rabbits, and after 48 hours in 1 rabbit (maximum score of 1). All signs were fully reversible, and no reactions were seen after 72 hours.
In conclusion, peroxidase can be classified as a 'non-irritant' to the rabbit eye.
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