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EC number: 232-877-2 | CAS number: 9032-08-0
- 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
Glucoamylase did not exert any skin and eye irritation.
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. 30 - Oct. 10, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Glucoamylase is also used in animal feed. Thus, in vivo skin irritation study were required to assess worker safety according to the provisions of Regulation EC 429/2008. Also, the findings from these studies were used for product classification and labelling in the US (OSHA, HSC).
- 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 3.9-4.0 kg
- Age at study initiation: Adults
- Housing: Individually, in animal room with control of temperature (18-24°C) and humidity (40-70%RH)
- Diet (e.g. ad libitum): Standard diet ad libitum
- Air changes (per hr): 10 per hr
- Water (e.g. ad libitum): Acidified tap water ad libitum
- Acclimation period: At least 12 weeks
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
IN-LIFE DATES: From: 2008-09-30 To: 2008-10-10 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- 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. 199.63 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 glucoamylase was assessed by semiocclusive application of 0.5 mL of the test material formulation to the closely-clipped dorsa of three 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:
- 0
- Max. score:
- 0
- 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:
- 0
- Max. score:
- 0
- 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:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No erythema, eschar formation or oedema was observed at the test sites at any of the three rabbits, neither at termination of exposure or at 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:
- The test material glucoamylase shall be classified as non-irritant according to the Commission Directive 2001/59/EC of 6 August 2001 adapting to the technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.
- Executive summary:
The acute dermal irritant effect of glucoamylase 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 initiated with one male New Zealand White rabbit, which was 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 back. A fourth similar area of skin served as negative control. After specified periods of application (respectively 3 minutes, 1 hour and 4 hours of exposure), the test item was removed from the test sites and the skin was examined. No erythema, eschar formation or oedema was observed at any of the test sites at any of the examinations. Two additional male animals were then included in the study and treated in the same manner. No erythema, eschar formation or oedema was observed at the test or control sites of any of the animals, neither at termination of exposure or at the examinations 1 hour, 24, 48 or 72 hours after termination of exposure.
The Test Item Mean Score for erythema after 4hrs of exposure to the test item was: 0.0
The Test Item Mean Score for oedema after 4hrs of exposure to the test item was: 0.0
In conclusion, glucoamylase shall be classified as non-irritant.
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:
- October 21-31 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Glucoamylase is also used in animal feed. Thus, in vivo skin irritation study were required to assess worker safety according to the provisions of Regulation EC 429/2008. Also, the findings from these studies were used for product classification and labelling in the US (OSHA, HSC).
- 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 initiation: 3.4-4.5 kg
- Housing: individually in PPO-plast cages (Noryl®; area 4200 cm2) with perforated floor
- Diet (e.g. ad libitum): Standard diet ad libitum
- Water (e.g. ad libitum): Acidified tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24°C
- Humidity (%): 40-70 %
- 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: 2008-10-21 To: 2008-10-31 - Vehicle:
- other: Tested neat
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test material, i.e. 199.63 mg total protein/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:
- cornea opacity score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness of conjunctiva)
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- At the 1 hour reading, discharge was present (score 1) in rabbit # 2. However, this symptom had disappeared at the following observations (24, 48 and 72 hours after treatment). At the examination 1 hour and 24 hours after exposure, discharge was present (score 1) in rabbit #3. However these symptoms had disappeared at the following observations 48 and 72 hours after treatment. No other effects were seen in any of the animals at any of the readings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Commission Directive 2001/59/EC of 6 August 2001, 3.2.6.2 Ocular lesions, Glucoamylase should not be classified as eye irritating.
- 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 the following day. 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. At the examination 24-hour after treatment, instillation of Fluorescein followed by flushing with 0.9% NaCl was included. UV-light was used to detect possible corneal damage.
The only effects seen were ocular discharge (score 1) in two rabbits at the 1 hour reading, still present in one rabbit at the 24 hr reading. However these symptoms had disappeared at the following observations 48 and 72 hours after treatment. No other effects were seen in any of the animals at any of the readings.
According to the Commission Directive 2001/59/EC of 6 August 2001, 3.2.6.2 Ocular lesions, glucoamylase should not be classified as eye irritating.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The skin and eye irritation potential of glucoamylase has been tested according to OECD guidelines, and in compliance with GLP. The only reaction seen was transient discharge (score 1) in 2 rabbits in the eye irritation study (totally cleared at 48h), all other readings in both studies were scored 0. The conclusion was that glucoamylase did not exert any skin and eye irritation.
Justification for classification or non-classification
The skin and eye irritation potential of glucoamylase has been tested according to OECD guidelines, and in compliance with GLP.
The conclusion was that glucoamylase did not exert any skin and eye irritation.
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