Registration Dossier
Registration Dossier
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EC number: 232-802-3 | CAS number: 9025-67-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26-01-1982 to 22-03-1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Code of Federal Regulations, title 16, § 1500.42
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, title 16, § 1500.42
- Deviations:
- yes
- Remarks:
- A few modifications.
- GLP compliance:
- no
- Remarks:
- Only inspection from quality assurance.
Test material
- Reference substance name:
- Inulinase
- EC Number:
- 232-802-3
- EC Name:
- Inulinase
- Cas Number:
- 9025-67-6
- Molecular formula:
- n.a.
- IUPAC Name:
- Inulinase
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Lot/batch No.: PPZ1281
- Expiration date of the lot/batch: April 1993
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino rabbits, Danish Landstrain
- Remarks:
- and part abraded.
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by novozymes A/S (previously known as Novo Industri A/S)
- Age at study initiation: Not stated.
- Weight at study initiation: 2.8-3.1 kg
- Housing: Galvanized steel cages with mesh floors and automatic watering in a room with the relative humidity.
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The chicken eye cornea was treated with 30 µL.
- Concentration (if solution): undiluted test sample, 86.6% TOS. - Duration of treatment / exposure:
- Eyelids were held together for about one second and then released.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours and again 7 days.
- Number of animals or in vitro replicates:
- 6 animals, 3 female and 3 males.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Except for the examination at 1 hour, one drop of 1% fluorescein sodium was used. The excess of fluorescein was flushed out with 0.9% sodium chloride solution.
- Time after start of exposure: The exposure period was 1 second. The eyes were examined at 1, 24, 48 and 72 hours and again 7 days.
SCORING SYSTEM: Code of Federal Regulations, title 16, § 1500.42
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.167
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- ulceration
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- ulceration
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- ulceration
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury, and cannot be classified under the GHS criteria.
- Executive summary:
An eye irritation test on 6 albino rabbits carried out with Novozym 230 (batch PPZ1281) according to the Code of Federal Regulations, title 16, § 1500.42.
0.06 g of the test substance corresponding to the volume 0.1 mL was placed in the left eye of each rabbit by gently pulling the lower lid away from the eye ball, and the test substance was carefully introduced into
the resulting cup. The lids were then gently held together for one second. The right eye, remaining untreated, served as a control.
The treatments resulted in slight conjunctival redness in two of the rabbits until 24 hours. This effect was reversible within 48 hours.
Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury.
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