Registration Dossier
Registration Dossier
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EC number: 253-446-5 | CAS number: 37288-54-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 November 2002 - 07 November 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Active enzyme protein of mannan endo-1,4-beta-mannosidase (EC no. 253-446-5, CAS no. 37288-54-3, EC name: Mannanase, endo-1,4-.beta.-, Enzyme Class No.: 3.2.1.78)
- Molecular formula:
- Not applicable, see remarks
- IUPAC Name:
- Active enzyme protein of mannan endo-1,4-beta-mannosidase (EC no. 253-446-5, CAS no. 37288-54-3, EC name: Mannanase, endo-1,4-.beta.-, Enzyme Class No.: 3.2.1.78)
- 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
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- -Substance type: UVCB
-Physical state: liqiud
-Storage: The test article was stored in the freezer and the refrigerator
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:
- The animals were supplied by Millbrook Breeding Labs, Amherst, MA.
The animals were born 08/04/2002. The pre-test body weight range was 2.4-2.6 kg. They were housed 1 per cage in suspended cages. The animal room was temperature controlled and had a 12-hour light/dark cycle.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye was dosed, while the other served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- After instillation, the eyelids were held together for approximately one second.
- Observation period (in vivo):
- The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours.
- Number of animals or in vitro replicates:
- 2 male and 1 female rabbit
- Details on study design:
- Scoring was done according to the Draize technique and OECD TG 405.
The eyes were not washed. Sodium fluorescein dye procedure was used at the 24-hour observation period.
A mini-Maglite flashlight with high intensity bulb was used for the examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other:
- 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
- Reversibility:
- other:
- 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
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- 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
- Reversibility:
- other:
- 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
- Reversibility:
- other:
- 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
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. As to conjunctival irritation, the following was noted: At the 1 hour reading, slight conjunctival effects in the form of redness, chemosis and discharge were present (score 1 for all parameters) in rabbit # 1, 2 and 3. In two animals this effect had disappeared at the following observations (24, 48 and 72 hours after treatment). At the examination at 24 hours after exposure, slight redness (score 1) without any swelling of the conjunctiva or any discharge remained in one of the three rabbits. All eye effects had cleared completely at the following observations, 48 and 72 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Mannanase is not classified as an eye irritant.
- Executive summary:
Three New Zealand White rabbits (2 males : 1 female) were used. 0.1 mL of mannanase was placed into the conjunctival sac of one eye of each rabbit. The eyes were examined and scored at 1, 24, 48 and 72 hours after dosing using Draize techniques. Sodium fluorescein dye procedure was used at the 24-hour observation period. The untreated eye served as control. No corneal opacity was noted at any scoring period. Slight conjuctival irritation was observed, but this cleared within 48 hours. The Primary Irritation Score was determined to be less than 1 and mannanase shall be classified as 'Non Irritant'.
GHS Classification: Not Classified
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