Registration Dossier
Registration Dossier
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EC number: 232-566-1 | CAS number: 9000-91-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep. 26 - Oct. 01, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across is considered applicable, as the two enzymes belong to the same enzyme sub-subclass and are considered similar with regard to their toxicological profile.
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 404 (Acute Dermal 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:
- liquid
- Details on test material:
- - Lot/batch No.: PPY 23880
- Expiration date of the lot/batch: 20 April 2014
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Charles River, Germany
- Weight at study initiation: between 1906 - 2174 g
- Age at study initiation: Adults
- Housing: Individually, in animal room with control of temperature (22-23°C) and humidity (50-70%RH)
- Diet (e.g. ad libitum): Standard diet ad libitum
- Air changes (per hr): 10 per hr
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES: From: 2007-10-01 To: 2007-10-04
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Tested neat
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted, i.e. 60 mg total protein/mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hrs
- Number of animals:
- 3
- Details on study design:
- The test compound alpha-amylase was assessed by semiocclusive application of 0.5 mL of the test material formulation to an area of 2.5 x 2.5 cm on the closely-clipped flank of three male New Zealand White rabbits for 4 hrs.
The study was conducted to comply with the following guidelines: Organisation for Economic Co-operation and Development (OECD) test guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema 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:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema 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:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema 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:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- At 1 h and 24 h after removal of the test material, very slight erythema was observed in the three rabbits. No erythema was observed at the 48 and 72 h reading. No oedema was observed at the test sites at any of the three rabbits at any of the examinations 1 hour, 24, 48 or 72 hours after termination of exposure.
- Other effects:
- No other effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Alpha-amylase was not irritating to skin and shall be classified as non-irritant.
- Executive summary:
The acute dermal irritant effect of alpha-amylase was investigated according to the method recommended in the OECD Guideline No 404, “Acute Dermal Irritation/Corrosion”. The study was conducted in accordance with GLP.
The study was performed on three male New Zealand White rabbits. They were each exposed to 0.5 mL of the undiluted liquid test item applied under semiocclusive conditions to each of three closely-clipped test sites, 2.5 x 2.5 cm, on the flank. After a 4-hour exposure period, the test item was removed from the test site and the skin was examined. Only very slight erythema was noted at 1 h and 24 h after removal of the test material, whereas eschar formation or oedema was not observed at any of the test sites at any of the examinations. All reactions were fully reversible and no erythema was observed at the test or control sites of any of the animals at the examinations at 48 or 72 hours after termination of exposure.
The Test Item Mean Score for erythema after 4 hrs of exposure to the test item was: 0.3
The Test Item Mean Score for oedema after 4 hrs of exposure to the test item was: 0.0
In conclusion, alpha-amylase was not irritating to skin and shall be classified as non-irritant.
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