Registration Dossier
Registration Dossier
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EC number: 232-802-3 | CAS number: 9025-67-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19-01-1982 to 22-03-1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Code of Federal Regulations 1979, title 16, § 1500.41 with a few modifications.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations 1979, title 16, § 1500.41 with a few modifications.
- Deviations:
- no
- Remarks:
- A few modifications.
- Principles of method if other than guideline:
- Instead of 24 hours the rabbits were only exposed to the test substance for 4 hours and readings were made 1, 24, 48 and 72 hours after the exposure had ended .
- GLP compliance:
- no
- Remarks:
- Only assessed by Quality Assurance.
Test material
- Reference substance name:
- Inulinase
- EC Number:
- 232-802-3
- EC Name:
- Inulinase
- Cas Number:
- 9025-67-6
- Molecular formula:
- n.a.
- IUPAC Name:
- Inulinase
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Lot/batch No.: PPZ1281
- Expiration date of the lot/batch: April 1993
Constituent 1
Constituent 2
Constituent 3
Constituent 4
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 novozymes A/S (previously known as Novo Industri A/S)
- Age at study initiation: Not stated.
- Weight at study initiation: 2.5-3.1 kg
- Housing: Galvanized steel cages with mesh floors and automatic watering in a room with the relative humidity.
- Diet (e.g. ad libitum): Ewos Brood Stock Feed for Rabbits and Guinea Pigs.
- Water (e.g. ad libitum): Automatic watering in a room.
IN-LIFE DATES: From: 1982-01-19 To: 1982-01-22
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- and part abraded
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): used as is (86.6% TOS) - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 1, 24, 48 and 72 hours.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch x 1 inch
- % coverage: 100%
- Type of wrap if used: Surgical gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not stated
- Time after start of exposure: After 4 hours of exposure, the coat, the patches and the test substance were removed and the resulting reactions were evaluated 1 hour later.
SCORING SYSTEM:
- Method of calculation: A primary irritation score was calculated according to 16 CFR 1500.41, 1979 by means of the 1, 24, 48 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.
- Executive summary:
A test for primary skin irritation in rabbits was carried out with Novozym 230 (batch PPZ1281) according to the Code of Federal Regulations 1979, title 16, § 1500.41 with a few modifications. Instead of 24 hours the rabbits were only exposed to the test substance for 4 hours and readings were made 1, 24, 48 and 72 hours after the exposure had ended.
Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.
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