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EC number: 232-983-9 | CAS number: 9075-68-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 08 - July 27, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to GLP and the procedures were according to the Code of Federal Regulations, title 16 § 1500.42 and adapted to OECD TG405 (1981).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal regulations, title 16, § 1500.42
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pullulanase
- EC Number:
- 232-983-9
- EC Name:
- Pullulanase
- Cas Number:
- 9075-68-7
- Molecular formula:
- not available
- IUPAC Name:
- Pullulanase
- 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
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Pullulanase SP 247, Toxbatch PPY 1323
- Substance type: UVCB
- Physical state: Powder
- Lot/batch No.: PPY 1323
- Expiration date of the lot/batch: At least stable until 1992-08-05
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature
- Storage condition of test material: 4 degrees of Celcius
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Danish Landstrain
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novo Industri, Denmark
- Weight at study initiation: between 2.7-3.2 kg
- Housing: Individually, in animal room with control of temperature (18-22°C) and relative humidity (30-35%)
- Diet : Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs)
- Water (e.g. ad libitum): tap water ad libitum
IN-LIFE DATES: From: 1982-06-08 To: 1982-06-11
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): 100 mg into the left eye - Duration of treatment / exposure:
- The test material was applied to the conjunctivel sac, no further action done, i.e. no washing.
- 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 female and 3 male 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.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- 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. Diffuse redness (3 rabbits, score 2), slight redness (3 rabbits, score 1) and slight chemosis (3 rabbits, score 1) were observed after 1 hour. After 24 hours only mild redness was seen in 2 rabbits (score 1). All signs were reversible, and no reactions were seen at the 48-hour reading.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, pullulanase 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 Pullulanase, batch PPY1323.
The eyes of six animals were checked for defects or irritation before instillation and only animals without defects were used.
100 mg of Pullulanase, batch PPY1323, 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 or iris reactions were noted at any time during the test. Diffuse or slight redness (max score 2) and slight chemosis (max score 1) were observed after 1 hour. After 24 hours only mild redness was seen in 2 rabbits (score 1). All signs were reversible, and no reactions were seen at the 48-hour reading.
In conclusion, pullulanase can be classified as a 'non-irritant' to the eye.
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