Registration Dossier
Registration Dossier
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EC number: 232-650-8 | CAS number: 9002-07-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 12, 1981 - January 15, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure was according to the Code of Federal Regulations 1979, title 16, § 1500.41
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations 1979, title 16, § 1500.41
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Active enzyme protein of trypsin (CAS no. 9002-07-7, EC no. 232-650-8, EC name trypsin, enzyme class 3.4.21.4)
- Molecular formula:
- n.a.
- IUPAC Name:
- Active enzyme protein of trypsin (CAS no. 9002-07-7, EC no. 232-650-8, EC name trypsin, enzyme class 3.4.21.4)
- Test material form:
- solid: granular
- Details on test material:
- Porcine concentrate of Pancrease Trypsin NOVO
- Physical state: Brown powder
- Name of test material (as cited in study report): Porcine concentrate of Pancras Trypsin NOVO
- Lot/batch No.: FTTE 193
- Storage condition of test material: Stability was kept by placing the test substance in refrigerator
- Expiration date of the lot/batch: At storage of 25°C, the product maintain declared activity for at least 3 months. At 5°C, the declared activity is maintained for at least a year.
Bovine concentrate of Pancrease Trypsin NOVO
- Physical state: Brown powder
- Name of test material (as cited in study report): Bovine concentrate of Pancras Trypsin NOVO
- Lot/batch No.: FTTE 056
- Storage condition of test material: Stability was kept by placing the test substance in refrigerator
Constituent 1
- Specific details on test material used for the study:
- Porcine concentrate of Pancrease Trypsin NOVO
- Physical state: Brown powder
- Name of test material (as cited in study report): Porcine concentrate of Pancras Trypsin NOVO
- Lot/batch No.: FTTE 193
- Storage condition of test material: Stability was kept by placing the test substance in refrigerator
Bovine concentrate of Pancrease Trypsin NOVO
- Physical state: Brown powder
- Name of test material (as cited in study report): Bovine concentrate of Pancras Trypsin NOVO
- Lot/batch No.: FTTE 056
- Storage condition of test material: Stability was kept by placing the test substance in refrigerator
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 Industry A/S
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in galvanized steel cages with mesh floors.
- Diet (e.g. ad libitum): Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs)
- Water (e.g. ad libitum): Automatic, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 40-60%
IN-LIFE DATES: From: 1981-11-17 To: 1981-11-20
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Abraded and non-abraded
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material (Porcine and Bovine Trypsin concentrate) moistened with 0.4 mL physiological saline. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- The test compounds, Porcine and Bovine Trypsin concentrate were assessed by occlusive application of 0.5 g of the test material moistened with 0.4 mL physiological saline to an areal 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 24 hrs.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 24 h
- Score:
- 2.67
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 72 h
- Score:
- 3.67
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Remarks:
- Intact skin
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 24 h
- Score:
- 3.83
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Remarks:
- porcine trypsin
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 72 h
- Score:
- 0.83
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24 h
- Score:
- 1.33
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 72 h
- Score:
- 1.67
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 24 h
- Score:
- 2.17
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 72 h
- Score:
- 3.67
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24 h
- Score:
- 0.83
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 24 h
- Score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- bovine trypsin
- Basis:
- mean
- Remarks:
- adraded skin
- Time point:
- 72 h
- Score:
- 0.67
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Porcine Trypsin 24 hours reading:
In 6/6 rabbits, intact skin sites applicated Porcine Typsin concentrate showed no reaction, while abraded skin sites showed well-defined to moderate erythema (score 2-3) and moderate to severe edema (score 3-4).
Porcine Trypsin 72 hours reading:
In 6/6 rabbits, intact skin sites applicated Porcine Typsin concentrate showed no reaction, while the main part of abraded skin sites showed a slight superficial eschar formation (score 4) but no chemosis.
Bovine Trypsin 24 hours reading:
In 4/6 rabbits, intact skin sites applicated Bovine Trypsin concentrate showed very slight to moderate erythema and edema (score 1-3), while intact skin sites in 2/6 rabbits showed no reactions. Abraded skin sites showed almost the same reaction as described for Procine Trypsin.
Bovine Trypsin 72 hours reading:
In 3/6 rabbits, intact skin applicated Bovine Trypsin concentrate showed well-defined erythema to slight superficial eschar formation (score 2-4) while intact skin sites in 3/6 rabbits showed no reactions. Abraded skin sites showed almost the same reaction as described for Porcine Trypsin.
Calculation of a primary irritation score for Porcine and Bovine Trypsin concentrate yielded 2.8 and 3.6, respectively
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the test conditions employed Porcine and Bovine concentrate of Pancreas Trypsin Novo had primary irritation scores of 2.8 and 3.6, respectivly. In the current GHS classification criteria it corresponds to Category 2 (irritant).
- Executive summary:
An in vivo skin irritation test was conducted to assess the potential of the test substances, Porcine (batch FTTE 193) and Bovine (batch FTTE 056) Trypsin concentrate to cause skin irritation. The Code of Federal regulations 1979, title 16, § 1500.41 was followed.
0.5 g of each test substance moistened with 0.4 mL physiological saline was applied under occlusive conditions on clipped intact and abraded skin on 6 rabbits (Danish Landstrain) for 24 hours. After 24 hours the patches were removed from the rabbits and resulting reactions evaluated. Readings were again made 72 hours after exposure.
The primary irritation score for Porcine Trypsin concentrate (24 and 72 hours reading on intact and abraded skin) was 2.8.
The primary irritation score for Bovine Trypsin concentrate (24 and 72 hours reading on intact and abraded skin) was 3.6.
Both test substances were found to be significant more irritating on abraded skin then on intact skin. The test substances were both classified as "moderate irritant" to skin.
Under the test conditions employed Porcine and Bovine concentrate of Pancreas Trypsin Novo had primary irritation scores of 2 .8 and 3.6, respectivly, and were both classified as "moderate irritant" to skin. In the current GHS classification criteria it corresponds to Category 2.
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