Mucorpepsin

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-05-11 to 1982-06-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to GLP and according to the Code of Federal Regulations 1979, title 16, 1500.41 and adapted to OECD Guidelines for Testing Chemicals

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Study conducted according to GLP and according to the Code of Federal Regulations 1979, title 16, 1500.41 and adapted to OECD Guidelines for Testing Chemicals.

Version / remarks:

1979

Deviations:

no

GLP compliance:

yes

Remarks:

GLP equivalent at the time. The study was subject to appropriate inspection by the quality assurance unit.

Test material

Test material information

Constituent 1

Reference substance name:

Active enzyme protein of mucorpepsin (CAS no.148465-73-0, EC no 642-981-3, enzyme class 3.4.23.23)

Molecular formula:

Not applicable

IUPAC Name:

Active enzyme protein of mucorpepsin (CAS no.148465-73-0, EC no 642-981-3, enzyme class 3.4.23.23)

Constituent 2

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

Constituent 3

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.

Constituent 4

Reference substance name:

Protein as a constituent of enzyme deriving from the fermentation or extraction process

Molecular formula:

Not available. See remarks.

IUPAC Name:

Protein as a constituent of enzyme deriving from the fermentation or extraction process

Constituent 5

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:

solid: particulate/powder

Details on test material:

- Lot/batch No.: PPR 1289
- Expiration date of the lot/batch: No specific expiry date. At least 10 years or as long as enzyme activity is preserved

Test animals

Species:

rabbit

Strain:

other: Danish Landstrain

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: 2.9-3.3 kg
- Housing: Individually in galvanized steel cages with mesh floors and automatic watering
- Diet (e.g. ad libitum): Standard diet

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22°C
- Humidity (%): 40 - 50%

IN-LIFE DATES: From: 1982-05-11 To: 1982-05-14

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Remarks:

Hair was clipped and skin abraded.

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:

30-60 minutes, 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: 1 inch by 1 inch
- Type of wrap if used: A coat of PVC

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30-60 minutes, 24 hours, 48 hours and 72 hours

SCORING SYSTEM:

Erythema and eschar formation
No erythema ....................................................................................................................................0
Very slight erythema (bar ely 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 (bar ely perceptible) ............................................................................................1
Slight edema (edges of area well-defined by definite raising) .........................................................2
Moderate edema (raised approximately 1 millimeter) ........................................................................3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) ......... 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Two of the female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal. The reaction was reversible, and no signs were seen at the reading at 24 hours.
None of the other animals showed any signs of reaction to the test substance during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Conclusions:

The study was conducted according to the Code of Federal Regulations 1979, title 16 § 1500.41. Two of the six female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal, which gave a primary irritation score of 0.16. However, the reaction was fully reversible, and no signs were observed at the reading at 24 hours. The irritation score for the mean of 24, 48 and 72 hours was 0. Therefore, according to the current classification, rennilase SP 252 was classified as a "non irritant" to the skin.

Executive summary:

The skin irritation effect of rennilase SP 252, batch PPR1289 was investigated according to the Code of Federal Regulations 1979, title 16 § 1500.41 and adapted to the OECD guidelines for testing of chemicals.

The study was performed on six rabbits. They were each exposed to 0.5 mL of the test material, applied under occlusive conditions to clipped intact and abraded skin (1 x 1 inch) on the back.

After a 4-hour exposure period, the test item was removed from the test site and the skin was examined after 30-60 minutes, 24 h, 48 h and 72 h.

Two of the six female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal, which gave a primary irritation score of 0.16. However, the reaction was fully reversible, and no irritation signs were seen at the reading at 24 hours. The irritation score for the mean of 24, 48 and 72 hours was 0.

Therefore, according to the current classification, rennilase SP 252 was classified as a "non irritant" to the skin.