Registration Dossier
Registration Dossier
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EC number: 232-565-6 | CAS number: 9000-90-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 26 - October 04, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Active enzyme protein of alpha-amylase (EC no. 232-565-6, CAS no. 9000-90-2, EC name: Amylase, alpha-, Enzyme Class No.: 3.2.1.1)
- Molecular formula:
- Not available
- IUPAC Name:
- Active enzyme protein of alpha-amylase (EC no. 232-565-6, CAS no. 9000-90-2, EC name: Amylase, alpha-, Enzyme Class No.: 3.2.1.1)
- 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:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Termamyl SC, PPY23880
- Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: PPY 23880
- Expiration date of the lot/batch: At least stable until 20 April 2014
- pH = 7.6
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature
- Storage condition of test material: minus 20 degrees of Celcius
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: Bred by Charles River, Germany
- Age at study initiation: Adults
- Weight at study start: 1956 - 2064 g
- Housing: individually in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): Standard diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23°C
- Humidity (%): 50-70 %
- Air changes (per hr): 10 air changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark cycle
IN-LIFE DATES: From: 2007-10-01 To: 2007-10-04
Test system
- Vehicle:
- other: Tested neat
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test material, i.e. 60 mg total protein/mL - Observation period (in vivo):
- The reactions were judged 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM: According to OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- At the 1 hour reading, discharge was present (score 1) in rabbit # 1. However, this symptom had disappeared at the following observations (24, 48 and 72 hours after treatment). At the examination at 1 hour and 24 hours after exposure, slight redness with or without slight swelling of the conjunctivae was present (score 1) in the three rabbits. However, these 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:
- The test material alpha-amylase is not irritating to eyes.
- Executive summary:
The study was carried out according to OECD guideline no. 405. Three rabbits were treated as follows: One rabbit was treated first and two more aprox. one hour later. An amount of 0.1 mL of the undiluted test substance was instilled in the conjunctival cul-de-sac of one of the eyes of the rabbit. After administration, the upper and the lower eye lid were carefully closed and subsequently held together for at least one second before releasing to prevent loss of material. The other eye remained untreated and served as a control. The reactions of the eyes were judged at 1 h, 24 h, 48 h and 72 h after treatment.
The only effects seen were ocular discharge (score 1) in one rabbit at the 1 hour reading, and slight redness with or without slight swelling of the conjunctivae (score 1) in all rabbits at the examination at 1 hour and 24 hours after exposure. However, these slight effects were cleared completely at the following observations 48 and 72 hours after treatment. According to the Globally Harmonised System of Classification and labelling of Chemicals (GHS, UN/ECE 2003) alpha-amylase should not be classified as eye irritating.
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