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EC number: 232-752-2 | CAS number: 9014-01-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Skin irritation, in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct. 12-27, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Subtilisin
- EC Number:
- 232-752-2
- EC Name:
- Subtilisin
- Cas Number:
- 9014-01-1
- Molecular formula:
- Not available.
- IUPAC Name:
- Subtilisin
- 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.
- 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:
- - Substance type: UVCB
- Physical state: Liquid
- Lot/batch No.: PPA 4852
- Expiration date of the lot/batch: No specific expiration date. At least 10 years or as long as enzyme activity is preserved
- Stability under test conditions: Solutions in water are stable for at least 24 hours at room temperature or 4 degrees Celcius
- Storage condition of test material: minus 18 degrees of C
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, UK
- Weight at study initiation: between 2.45 - 2.65 kg
- Age at study initiation: Young adults, approx. 3 months
- Housing: Individually, in animal room with control of temperature (15-23C) and humidity (40-70%RH)
- Diet (e.g. ad libitum): Standard diet ad libitum
- Water (e.g. ad libitum): Automatic, ad libitum
- Acclimation period: 7 days
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES: From: 1994-10-12 To: 1994-10-27
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of the test material diluted to retail activity (445 mg test material made up to 1000 mg with water), corresponding to a solution with 4.5% active enzyme protein
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 16 days
- Number of animals:
- 3
- Details on study design:
- The test compound Subtilisin 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:
- other: Mean of 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Very slight exfoliation was evident until termination of the study (day16) in the present animal.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Mean 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Exfoliation was seen until day 13 in this animal, all other effects were cleared at day 10.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Mean 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight or well defined erythema and very slight to moderate oedema were observed at the test sites of two animals during the first 72 hrs after bandage removal. One of these animals also showed a dry abrasion over the majority of the test site during this time. One week after treatment, very slight erythema and exfoliation were evident in both animals. The exfoliation persisted until day 13 in one animal and to termination of the study in the other. No dermal response was observed at the tests site of the third animal at any time during the observation period.
The mean values for erythema and oedema recorded 24, 48 and 72 hours after treatment did not exceed the limit values considered to indicate a significant inflammatory response.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- According to EC-standards (as published in the Official Journal of the European Communities, L 110 A, 4 May 1993), the test material is not irritating to skin. Concentration of solution applied was 4.5% expressed as active enzyme protein.
- Executive summary:
An in vivo skin irritation test was conducted to assess the potential of the test substance, Subtilisin, batch PPA 4852, to cause skin irritation. The OECD test guideline 404 was followed. 0.5 mL of the test material formulation was applied under semiocclusive conditions to the closely-clipped dorsa of three New Zealand White rabbits for 4 hrs. The study was conducted in accordance with GLP. The study concluded that the test substance, Subtilisin, was non-irritant to the skin.
However due to the very slight exfoliation still seen in one animal at the termination of the study, Subtilisin should be regarded as slightly irritant to skin.
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