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EC number: 232-566-1 | CAS number: 9000-91-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Endpoint summary
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- 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
Beta-amylase was not tested for irritation, however, and enzyme from the same sub-subclass - alpha-amylase - was tested.
Alpha-amylase was not irritating to skin and shall be classified as non-irritant.
Based on these results, beta-amylase should also be 'non-irritating' to eyes and 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:
- Sep. 26 - Oct. 01, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across is considered applicable, as the two enzymes belong to the same enzyme sub-subclass and are considered similar with regard to their toxicological profile.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Charles River, Germany
- Weight at study initiation: between 1906 - 2174 g
- Age at study initiation: Adults
- Housing: Individually, in animal room with control of temperature (22-23°C) and humidity (50-70%RH)
- Diet (e.g. ad libitum): Standard diet ad libitum
- Air changes (per hr): 10 per hr
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES: From: 2007-10-01 To: 2007-10-04 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Tested neat
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted, i.e. 60 mg total protein/mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hrs
- Number of animals:
- 3
- Details on study design:
- The test compound alpha-amylase was assessed by semiocclusive application of 0.5 mL of the test material formulation to an area of 2.5 x 2.5 cm on the closely-clipped flank of three male New Zealand White rabbits for 4 hrs.
The study was conducted to comply with the following guidelines: Organisation for Economic Co-operation and Development (OECD) test guideline 404. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- At 1 h and 24 h after removal of the test material, very slight erythema was observed in the three rabbits. No erythema was observed at the 48 and 72 h reading. No oedema was observed at the test sites at any of the three rabbits at any of the examinations 1 hour, 24, 48 or 72 hours after termination of exposure.
- Other effects:
- No other effects.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Alpha-amylase was not irritating to skin and shall be classified as non-irritant.
- Executive summary:
The acute dermal irritant effect of alpha-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 three male New Zealand White rabbits. They were each exposed to 0.5 mL of the undiluted liquid test item applied under semiocclusive conditions to each of three closely-clipped test sites, 2.5 x 2.5 cm, on the flank. After a 4-hour exposure period, the test item was removed from the test site and the skin was examined. Only very slight erythema was noted at 1 h and 24 h after removal of the test material, whereas eschar formation or oedema was not observed at any of the test sites at any of the examinations. All reactions were fully reversible and no erythema was observed at the test or control sites of any of the animals at the examinations at 48 or 72 hours after termination of exposure.
The Test Item Mean Score for erythema after 4 hrs of exposure to the test item was: 0.3
The Test Item Mean Score for oedema after 4 hrs of exposure to the test item was: 0.0
In conclusion, alpha-amylase was not irritating to skin and shall be classified as non-irritant.
- Endpoint:
- skin irritation: 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
Referenceopen allclose all
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:
- September 26 - October 04, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across is considered applicable, as the two enzymes belong to the same enzyme sub-subclass and are considered similar with regard to their toxicological profile.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Charles River, Germany
- Age at study initiation: Adults
- Weight at study start: 1956 - 2064 g
- Housing: individually in stainless steel cages with perforated floor
- Diet (e.g. ad libitum): Standard diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23°C
- Humidity (%): 50-70 %
- Air changes (per hr): 10 air changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark cycle
IN-LIFE DATES: From: 2007-10-01 To: 2007-10-04 - Vehicle:
- other: Tested neat
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Observation period (in vivo):
- The reactions were judged 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM: According to OECD 405 - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- At the 1 hour reading, discharge was present (score 1) in rabbit # 1. However, this symptom had disappeared at the following observations (24, 48 and 72 hours after treatment). At the examination at 1 hour and 24 hours after exposure, slight redness with or without slight swelling of the conjunctivae was present (score 1) in the three rabbits. However, these eye effects had cleared completely at the following observations, 48 and 72 hours after treatment.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material alpha-amylase is not irritating to eyes.
- Executive summary:
The study was carried out according to OECD guideline no. 405. Three rabbits were treated as follows: One rabbit was treated first and two more aprox. one hour later. An amount of 0.1 mL of the undiluted test substance was instilled in the conjunctival cul-de-sac of one of the eyes of the rabbit. After administration, the upper and the lower eye lid were carefully closed and subsequently held together for at least one second before releasing to prevent loss of material. The other eye remained untreated and served as a control. The reactions of the eyes were judged at 1 h, 24 h, 48 h and 72 h after treatment.
The only effects seen were ocular discharge (score 1) in one rabbit at the 1 hour reading, and slight redness with or without slight swelling of the conjunctivae (score 1) in all rabbits at the examination at 1 hour and 24 hours after exposure. However, these slight effects were cleared completely at the following observations 48 and 72 hours after treatment. According to the Globally Harmonised System of Classification and labelling of Chemicals (GHS, UN/ECE 2003) alpha-amylase should not be classified as eye irritating.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 15 2002 to January 16 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Read aross is considered applicable, since the two enzymes belong to the same enzyme sub-subclass and are considered similar with regard to their toxicological profile.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The chicken eye cornea was treated with 0.03 mL
- Concentration (if solution): undiluted test sample - Duration of treatment / exposure:
- The exposure period was 10 seconds
- Observation period (in vivo):
- The eyes were examined at ca 0, 30, 75, 120, 180 and 240 minutes after treatment.
- Details on study design:
- Alpha-amylase was examined for potential irritation/corrosive properties in an ex vivo bioassay, the Chicken Enucleated Eye Test (CEET). Three main parameters were measured to disclose possible adverse effects, the corneal thickness/swelling, corneal opacity and fluorescein retention of damaged epithelial cells.
The study was carried out at the contract laboratory TNO Nutrition and Food Research, The Netherlands. Three enucleated chicken eyes per sample and one control per test run were selected for testing. At time t = 0, immediately after a zero reference measurement, the following procedure was applied for each test eye: The eye cornea was treated with 0.03 mL of the undiluted test item. After an exposure period of 10 seconds, the corneal surface was rinsed thoroughly with 20 mL isotonic saline of ambient temperature. The control eye was treated with saline only. The eyes were examined at ca 0, 30, 75, 120, 180 and 240 minutes after treatment. Fluorescein retention was only evaluated at ca 30 minutes after treatment. All examinations were carried out with a slit-lamp microscope.
In addition, the eyes were collected for histopathological examination of the cornea. - Irritation parameter:
- percent corneal swelling
- Value:
- 2
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein retention score
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- After treatment, the corneal thickness of the test eyes remained unchanged. None of the three eyes showed any corneal opacity or fluorescein retention. Microscopic examinations of the treated corneas did not reveal any indications of possible adverse effects.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of the results obtained by slit-lamp examination and according to the EC classification system of the Chicken Enucleated Eye Test, it was concluded that the tested alpha-amylase batch was not irritating to eyes.
- Executive summary:
Alpha-amylase was examined for potential irritation/corrosive properties in an ex vivo bioassay, the Chicken Enucleated Eye Test.
Three main parameters were measured to disclose possible adverse effects, the corneal swelling, corneal opacity and fluorescein retention of damaged epithelial cells.
Three enucleated chicken eyes per sample and one control were selected for testing. The individual eye cornea was treated with 0.03 mL of the undiluted test material. After an exposure period of 10 seconds, the corneal surface was rinsed with 20 mL isotonic saline. The control eye was treated with saline only. The eyes were examined at 0, 30, 75, 120, 180 and 240 minutes after treatment. All examinations were carried out with a slit-lamp microscope.
In addition, the eyes were collected for histopathological examination of the cornea.
The results showed that the corneal thickness of the test eyes remained unchanged. None of the three eyes showed any corneal opacity or fluorescein retention. Microscopic examinations of the treated corneas did not reveal any indications of possible adverse effects.
According to the EC classification system of the Chicken Enucleated Eye Test, it was concluded that the tested alpha-amylase was not irritating to eyes.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Not classified.
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