Registration Dossier
Registration Dossier
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EC number: 232-983-9 | CAS number: 9075-68-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 11 - June 16, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test procedure was according to the Code of Federal Regulations 1979, title 16, § 1500.41 and adapted to OECD TG404 (1981). Test procedure according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations 1979, title 16, § 1500.41
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Pullulanase
- EC Number:
- 232-983-9
- EC Name:
- Pullulanase
- Cas Number:
- 9075-68-7
- Molecular formula:
- not available
- IUPAC Name:
- Pullulanase
- 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.
- 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.
- 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.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Pullulanase SP 247, Toxbatch PPY 1323
- Substance type: UVCB
- Physical state: Powder
- Lot/batch No.: PPY 1323
- Expiration date of the lot/batch: At least stable until 1992-08-05
- Stability under test conditions: The test material is stable for at least 24 hours at room temperature
- Storage condition of test material: 4 degrees of Celcius
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- other: Albino rabbits, Danish Landstrain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novo Industri A/S, Denmark (Renamed Novo Nordisk A/S in year 1989)
- Weight at study initiation: between 2.9 - 3.3 kg
- Age at study initiation: Young adults
- Housing: Individually in galvanized steel cages with mesh floors
- Diet (e.g. ad libitum): Standard diet
- Water (e.g. ad libitum): Tap water ad libitum
- Temperature (°C): 18 to 22 °C
- Humidity (%): 40-50%
- Acclimation period: The animals were bred in-house
IN-LIFE DATES: From: 1982-05-11 To: 1982-05-14
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Shaved, abraded and non-abraded
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration: undiluted, 10% w/w total protein (100 mg total protein/g) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hrs
- Number of animals:
- 6
- Details on study design:
- The test compound pullulanase was assessed by semiocclusive application of 0.5 g of the test material moistened with saline to an area of 1 inch x 1 inch (2.5 x 2.5 cm) on the closely-clipped intact and abraded skin on the back of three male and three female albino rabbits for 4 hrs.
The study was conducted to comply with the following guideline:
- Code of Federal Regulations 1979, title 16, § 1500.41, adapted to OECD TG404.
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
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- 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 six rabbits at the examinations 30 minutes, 24, 48 or 72 hours after termination of exposure. This result was obtained for test sites of intact as well as abraded skin.
- Other effects:
- No other effects.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material pullulanase is not irritating to skin.
- Executive summary:
The acute dermal irritant effect of pullulanase was investigated according to the guideline Code of Federal Regulations 1979, title 16, § 1500.41 and adapted to OECD TG404 (1981) “Acute Dermal Irritation/Corrosion”. The study was conducted in accordance with GLP.
The study was performed on three male and three female albino rabbits, Danish Landstrain. They were each exposed to 0.5 g of the test material, moistened with saline, applied under semiocclusive conditions to each of the closely-clipped intact and abraded test sites (2.5 x 2.5 cm) on the back.
After a 4 -hour exposure period, the test item was removed from the test site and the skin was examined after 30 minutes, 24 h, 48 h and 72 h. No erythema, eschar formation or oedema was observed at any of the test sites at any of the examinations.
In conclusion, pullulanase was not irritating to skin and shall be classified as non-irritant.
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