Registration Dossier
Registration Dossier
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EC number: 630-523-5 | CAS number: 160611-47-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 3, 1985 to February 19, 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal regulations, title 16, § 1500.42
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Active enzyme protein of glucan 1,4-alpha-maltohydrolase (EC no. 232-575-0, CAS no.160611-47-2, EC name glucan 1,4-alpha-maltohydrolase, Enzyme class no 3.2.1.133 )
- Molecular formula:
- n.a.
- IUPAC Name:
- Active enzyme protein of glucan 1,4-alpha-maltohydrolase (EC no. 232-575-0, CAS no.160611-47-2, EC name glucan 1,4-alpha-maltohydrolase, Enzyme class no 3.2.1.133 )
- 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:
- 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:
- 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
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Maltogen amylase, SP 295, batch no. PPY 1624
- Substance type: UVCB
- Physical state: Liquid
- Lot/batch No.: PPY 1624
- Expiration date of the lot/batch: At least stable until 1994-07-05
- Stability under test conditions: The test material is stable for at least 4 hours at room temperature
- Storage condition of test material: 4 degrees of Celcius
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: Males (average): 3.2 kg, females (average): 3.5 kg
- Housing: Individually in galvanized steel cages with mesh floor.
- Diet : Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: The animals were bred in-house
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 35-60%
IN-LIFE DATES: From: 1985-12-03 To: 1985-12-10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: undiluted
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. - Duration of treatment / exposure:
- The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The other eye, remaining untreated, serves as a control.
- Observation period (in vivo):
- The reactions were observed at 1, 24, 48, 72 hours and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- 3 female and 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: The ocular reactions were recorded 1, 24, 48, 72 hours and 7 days after instillation of the test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #19, #21, #22, #23, #24
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #20
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (ulceration)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal opacity or iris reactions were noted at any time during the test. Only very slight redness of the conjunctiva of animal #23 at 1 hour and of animal #20 at 24 hours were observed.
All signs were reversible within 48 h.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, maltogen amylase can be classified as a ‘non irritant’ to the rabbit eye.
- Executive summary:
Maltogen amylase, was instilled in the conjunctival sac of 6 rabbits in order to examine the irritation potential to the eyes. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48, 72 hours and 7 days after instillation according to the specified guideline.
No corneal opacity or iris reactions were noted at any time during the test. Only very slight redness of the conjunctiva of animal #20 at 24 hours was observed, however, this was fully reversible within 48 hours. All signs were reversible, and no reactions were seen after 48 or 72 hours, or after 7 days.
In conclusion, maltogen amylase can be classified as a 'non-irritant' to the eyes.
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