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EC number: 630-523-5 | CAS number: 160611-47-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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
- 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 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 - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Not classified.
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