Registration Dossier
Registration Dossier
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EC number: 232-619-9 | CAS number: 9001-62-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 March 2009 - 05 August 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Lipase is also used in animal feed. Thus, in vivo eye irritation study were required to assess worker safety according to the provisions of Regulation EC 429/2008. Also, the findings from these studies were used for product classification and labelling in the US (OSHA, HSC).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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 Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- Cas Number:
- 9001-62-1
- Molecular formula:
- Not applicable, see remarks
- IUPAC Name:
- Active enzyme protein of Lipase, triacylglycerol (EC no. 232-619-9, CAS no. 9001-62-1, EC name: Lipase, triacylglycerol, Enzyme Class No.: 3.1.1.3)
- 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: translucent tan liquid
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: Covance Research Products, Inc., Denver, PA.
- Age at study initiation: Approximately 19 weeks
- Weight at study initiation: 2.8 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 March 2009 To: 28 March 2009
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Contralateral eye served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Eyelids were held together for about one second and then released.
- Observation period (in vivo):
- Assessment of ocular damage/irriation was made at 1, 24, 48 and 72 hours post dose.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Calculated from the weighted Draize scale
TOOL USED TO ASSESS SCORE: Mini-Maglite® flashlight; fluorescein at the 24 hr observation interval with ultraviolet light source.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- animal: 1, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Remarks on result:
- other: No ocular effects were noted during the study
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted as discharge at the 1-hour reading in 1/3 eyes, cleared by 24 hours.
No other ocular effects were observed in any of the three animals at any time during the study. The substance is not classified as an eye irritant under GHS criteria based on the results of this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Lipase should be classified as "Non Irritant".
- Executive summary:
The study was conducted according to OECD Guideline No. 405 and complied with all GLP standards.
Three New Zealand rabbits (1 female; 2 males) were used. The test article (0.1 mL) was instilled in one eye/rabbit. The eyes were scored at 1, 24, 48 and 72 hours post dosing. Sodium fluorescein dye procedures were used at the 24-hour observation interval. The untreated eye served as control.
There were no effects on cornea or iris at any scoring time. Conjunctival irritation, noted as discharge at the 1-hour reading in one animal only, cleared by 24 hours. The eye irritation score based on the 24, 48 and 72 hrs scoring was 0. There were no overt signs of systemic toxicity. Lipase is judged to be a non-irritant to the eye.
GHS Classification: Not classified
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