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Registration Dossier
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EC number: 232-991-2 | CAS number: 9080-56-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-07-1994 to 16-03-1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- 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
Test material
- Reference substance name:
- Active enzyme protein of Bacillolysin (EC no. 232-991-2, CAS no.9080-56-2, EC name Bacillolysin, Enzyme class no 3.4.24.28 )
- Molecular formula:
- Not available
- IUPAC Name:
- Active enzyme protein of Bacillolysin (EC no. 232-991-2, CAS no.9080-56-2, EC name Bacillolysin, Enzyme class no 3.4.24.28 )
- 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.: PPA4800
- Expiration date of the lot/batch: 10-05-2004
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: Charles River (UK) Limited
- Weight at study initiation: 3.17 - 3.67 kg
- Housing: Housed in suspended stainless steel cages mounted in mobile batteries.
- Diet (e.g. ad libitum): Standard pelleted rabbit diet STANRAB (P) SQC
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (range 15°C - 23°C)
- Humidity (%): 55% (40% - 70%)
IN-LIFE DATES: From: 1994-11-15 To: 1994-11-18
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24 hours, 48 hours and 72 hours.
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 3 x 2 cm
- Type of wrap if used: gauze patch held in place by strips of Blenderm. The control was covered by a similar semi-occlusive dressing but otherwise remained untreated.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
- Time after start of exposure: 5 hours
OBSERVATION TIME POINTS
1 hour, 24 hours, 48 hours and 72 hours.
SCORING SYSTEM:
Erythema and eschar formation
No erythema ....................................................................................................................................0
Very slight erythema (barely perceptible) .......................................................................................1
Well-defined erythema .....................................................................................................................2
Moderate to severe erythema ..........................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in the depth) ......................4
Edema formation
No edema ..........................................................................................................................................0
Very slight edema (barely perceptible) ............................................................................................1
Slight edema (edges of area well-defined by definite raising) .........................................................2
Moderate edema (raised approximately 1 mm) .................................................................................3
Severe edema (raised more than 1 mm and extending beyond the area of exposure) .................. 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Under the conditions of this test and the criteria of the EEC, neutrase was classified as 'non-irritant' to skin. The formulation had a dry matter content of 23.4% and a total organic solids content of 16.1%.
- Executive summary:
The potential of the retail concentration of neutrase PPA 4800, hereafter referred to as neutrase, to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 mL of the test material formulation to the closely-clipped dorsa of three New Zealand White rabbits for five hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal irritation response was observed at the test site of any rabbit at any time during the 72-hour observation period.
Under the conditions of this test and the criteria of the EEC, neutrase was classified as 'non-irritant' to skin. The formulation had a dry matter content of 23.4% and a total organic solids content of 16.1%.
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