Registration Dossier
Registration Dossier
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EC number: 630-523-5 | CAS number: 160611-47-2
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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
Test material
- Reference substance name:
- Active enzyme protein of glucan 1,4-alpha-maltohydrolase (EC no. 232-575-0, CAS no.160611-47-2, EC name glucan 1,4-alpha-maltohydrolase, Enzyme class no 3.2.1.133 )
- Molecular formula:
- n.a.
- IUPAC Name:
- Active enzyme protein of glucan 1,4-alpha-maltohydrolase (EC no. 232-575-0, CAS no.160611-47-2, EC name glucan 1,4-alpha-maltohydrolase, Enzyme class no 3.2.1.133 )
- 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
- 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
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Maltogen amylase, SP 295, batch no. PPY 1624
- Substance type: UVCB
- Physical state: Liquid
- Lot/batch No.: PPY 1624
- Expiration date of the lot/batch: At least stable until 1994-07-05
- Stability under test conditions: The test material is stable for at least 4 hours at room temperature
- Storage condition of test material: 4 degrees of Celcius
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- 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: 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
Test system
- 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.
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
- 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
Applicant's summary and conclusion
- 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.
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