Registration Dossier
Registration Dossier
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EC number: 232-877-2 | CAS number: 9032-08-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep. 30 - Oct. 10, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Glucoamylase is also used in animal feed. Thus, in vivo skin 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 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 Amylase, gluco- (EC no. 232-877-2, CAS no. 9032-08-0, EC name: glucan 1,4-alpha-glucosidase, Enzyme Class no. 3.2.1.3)
- IUPAC Name:
- Active enzyme protein of Amylase, gluco- (EC no. 232-877-2, CAS no. 9032-08-0, EC name: glucan 1,4-alpha-glucosidase, Enzyme Class no. 3.2.1.3)
- 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
- Test material form:
- liquid
- Details on test material:
- Substance type: UVCB
- Physical state: liquid
- Lot/batch No.: trg08050/52
- Expiration date of the lot/batch: At least stable until January 2011
- Stability under test conditions: The test material and dilutions in water (25% and 50%) are stable for
at least 5 hours at room temperature, 7 days at 4 degrees Celcius and 90 days at minus 20 degrees
of Celcius
- Storage condition of test material: minus 20 degrees of Celcius
Constituent 1
Constituent 2
Constituent 3
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 3.9-4.0 kg
- Age at study initiation: Adults
- Housing: Individually, in animal room with control of temperature (18-24°C) and humidity (40-70%RH)
- Diet (e.g. ad libitum): Standard diet ad libitum
- Air changes (per hr): 10 per hr
- Water (e.g. ad libitum): Acidified tap water ad libitum
- Acclimation period: At least 12 weeks
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES: From: 2008-09-30 To: 2008-10-10
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- 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. 199.63 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 glucoamylase was assessed by semiocclusive application of 0.5 mL of the test material formulation to the closely-clipped dorsa of three 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:
- 0
- Max. score:
- 0
- 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:
- 0
- Max. score:
- 0
- 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:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No erythema, eschar formation or oedema was observed at the test sites at any of the three rabbits, neither at termination of exposure or at 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:
- The test material glucoamylase shall be classified as non-irritant according to the Commission Directive 2001/59/EC of 6 August 2001 adapting to the technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.
- Executive summary:
The acute dermal irritant effect of glucoamylase 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 initiated with one male New Zealand White rabbit, which was 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 back. A fourth similar area of skin served as negative control. After specified periods of application (respectively 3 minutes, 1 hour and 4 hours of exposure), the test item was removed from the test sites and the skin was examined. No erythema, eschar formation or oedema was observed at any of the test sites at any of the examinations. Two additional male animals were then included in the study and treated in the same manner. No erythema, eschar formation or oedema was observed at the test or control sites of any of the animals, neither at termination of exposure or at the examinations 1 hour, 24, 48 or 72 hours after termination of exposure.
The Test Item Mean Score for erythema after 4hrs of exposure to the test item was: 0.0
The Test Item Mean Score for oedema after 4hrs of exposure to the test item was: 0.0
In conclusion, glucoamylase shall be classified as non-irritant.
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