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Toxicological information

Skin irritation / corrosion

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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:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
powder
Details on test material:
- Lot/batch No.: PPZ1281
- Expiration date of the lot/batch: April 1993

Test animals

Species:
rabbit
Strain:
other: Albino rabbits, Danish Landstrain.
Details on test animals 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.