Registration Dossier

Administrative data

Description of key information

Glucan 1,4-alpha-maltohydrolase was tested for skin and eye irritation.

- Maltogen amylase was not irritating and can be classified as a ‘non irritant’ to the rabbit eye.

- Maltogen amylase was not irritating and can be classified as a ‘non irritant’ to the rabbit skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From December 10, 1985 to February 19, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
The irritation to the skin was measured after exposure of the test material to both abraded and intact skin of the rabbit, clipped free of hair.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: Males (average): 3.2 kg, females (average): 3.4 kg
- Housing: Individually in galvanized steel cages with mesh floor.
- Diet: Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: The animals were bred in-house

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 35-55%

IN-LIFE DATES: From: 1985-12-10 To: 1985-12-13
Type of coverage:
occlusive
Preparation of test site:
other: Shaved, abraded and non-abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: Undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hrs
Number of animals:
6
Details on study design:
The test compound maltogen amylase was assessed by occlusive application of 0.5 mL of the test material on the closely-clipped intact and abraded skin on the back of three male and three female albino rabbits for 4 hrs.

The study was conducted according to OECD TG 404, to which was added exposure of abraded skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
animal: #25
Time point:
24/48/72 h
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Abraded skin
Irritation parameter:
erythema score
Basis:
animal: #26
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Abraded skin
Irritation parameter:
erythema score
Basis:
animal: #27, #29, #30
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Abraded skin
Irritation parameter:
erythema score
Basis:
animal: #28
Time point:
24/48/72 h
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Abraded skin
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions employed, maltogen amylase, was not found to be irritant to the skin.
Executive summary:

The acute dermal irritant effect of maltogen amylase was investigated according to the method recommended in the OECD Guideline No 404, “Acute Dermal Irritation/Corrosion”. The study was conducted in accordance with GLP. The study was performed on six (3 males and 3 females) New Zealand White rabbits. They were each exposed to 0.5 mL of the undiluted liquid test item applied under occlusive conditions of each of the closely-clipped intact and abraded test sites on the back of the animals. After a 4-hour exposure period, the test item was removed from the test site and the skin was examined after 30 minutes, 24 h, 48 h and 72 h.

No reactions were observed at the intact skin sites after contact with maltogen amylase, batch PPY 1624, for 4 hours. At the abraded sites very slight redness was observed in 4 rabbits and very slight edema (at 0.5 hour only) in 2 rabbits. All reactions had disappeared at the 72 hours reading.

Maltogen amylase (IUBMB 3.2.1.133) is classified as non-irritant to skin.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From December 3, 1985 to February 19, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: Code of Federal regulations, title 16, § 1500.42
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: Males (average): 3.2 kg, females (average): 3.5 kg
- Housing: Individually in galvanized steel cages with mesh floor.
- Diet : Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: The animals were bred in-house

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 35-60%

IN-LIFE DATES: From: 1985-12-03 To: 1985-12-10
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration: undiluted
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped.
Duration of treatment / exposure:
The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The other eye, remaining untreated, serves as a control.
Observation period (in vivo):
The reactions were observed at 1, 24, 48, 72 hours and 7 days after instillation of the test material.
Number of animals or in vitro replicates:
3 female and 3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: The ocular reactions were recorded 1, 24, 48, 72 hours and 7 days after instillation of the test material.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #19, #21, #22, #23, #24
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #20
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(ulceration)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal opacity or iris reactions were noted at any time during the test. Only very slight redness of the conjunctiva of animal #23 at 1 hour and of animal #20 at 24 hours were observed.
All signs were reversible within 48 h.
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, maltogen amylase can be classified as a ‘non irritant’ to the rabbit eye.
Executive summary:

Maltogen amylase, was instilled in the conjunctival sac of 6 rabbits in order to examine the irritation potential to the eyes. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48, 72 hours and 7 days after instillation according to the specified guideline.

No corneal opacity or iris reactions were noted at any time during the test. Only very slight redness of the conjunctiva of animal #20 at 24 hours was observed, however, this was fully reversible within 48 hours. All signs were reversible, and no reactions were seen after 48 or 72 hours, or after 7 days.

In conclusion, maltogen amylase can be classified as a 'non-irritant' to the eyes.

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

Additional information

Justification for classification or non-classification

Not classified.