Registration Dossier

Administrative data

Description of key information

Inulinase was tested in rabbits for skin and eye irritation.

- Under the test conditions employed, Novozym 230 had a primary irritation score of 0.0 and was classified as a "non irritant" to skin.

- Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury, and cannot be classified under the GHS criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
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.
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.
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
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26-01-1982 to 22-03-1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Code of Federal Regulations, title 16, § 1500.42
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, title 16, § 1500.42
Deviations:
yes
Remarks:
A few modifications.
GLP compliance:
no
Remarks:
Only inspection from quality assurance.
Species:
rabbit
Strain:
other: Albino rabbits, Danish Landstrain
Remarks:
and part abraded.
Details on test animals or tissues 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: 2.8-3.1 kg
- Housing: Galvanized steel cages with mesh floors and automatic watering in a room with the relative humidity.
Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The chicken eye cornea was treated with 30 µL.
- Concentration (if solution): undiluted test sample, 86.6% TOS.
Duration of treatment / exposure:
Eyelids were held together for about one second and then released.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours and again 7 days.
Number of animals or in vitro replicates:
6 animals, 3 female and 3 males.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Except for the examination at 1 hour, one drop of 1% fluorescein sodium was used. The excess of fluorescein was flushed out with 0.9% sodium chloride solution.
- Time after start of exposure: The exposure period was 1 second. The eyes were examined at 1, 24, 48 and 72 hours and again 7 days.

SCORING SYSTEM: Code of Federal Regulations, title 16, § 1500.42
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0.167
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
ulceration
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
ulceration
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
ulceration
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury, and cannot be classified under the GHS criteria.
Executive summary:

An eye irritation test on 6 albino rabbits carried out with Novozym 230 (batch PPZ1281) according to the Code of Federal Regulations, title 16, § 1500.42.

0.06 g of the test substance corresponding to the volume 0.1 mL was placed in the left eye of each rabbit by gently pulling the lower lid away from the eye ball, and the test substance was carefully introduced into

the resulting cup. The lids were then gently held together for one second. The right eye, remaining untreated, served as a control.

The treatments resulted in slight conjunctival redness in two of the rabbits until 24 hours. This effect was reversible within 48 hours.

Under the test conditions employed, Novozym 230 was regarded as negative as to potential for eye injury.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Not classified.