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EC number: 232-983-9 | CAS number: 9075-68-7
- 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
Pullulanase is neither a skin or an eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 11 - June 16, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Test procedure was according to the Code of Federal Regulations 1979, title 16, § 1500.41 and adapted to OECD TG404 (1981). Test procedure according to GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations 1979, title 16, § 1500.41
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Albino rabbits, Danish Landstrain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novo Industri A/S, Denmark (Renamed Novo Nordisk A/S in year 1989)
- Weight at study initiation: between 2.9 - 3.3 kg
- Age at study initiation: Young adults
- Housing: Individually in galvanized steel cages with mesh floors
- Diet (e.g. ad libitum): Standard diet
- Water (e.g. ad libitum): Tap water ad libitum
- Temperature (°C): 18 to 22 °C
- Humidity (%): 40-50%
- Acclimation period: The animals were bred in-house
IN-LIFE DATES: From: 1982-05-11 To: 1982-05-14 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Shaved, abraded and non-abraded
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration: undiluted, 10% w/w total protein (100 mg total protein/g) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hrs
- Number of animals:
- 6
- Details on study design:
- The test compound pullulanase was assessed by semiocclusive application of 0.5 g of the test material moistened with saline to an area of 1 inch x 1 inch (2.5 x 2.5 cm) 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 to comply with the following guideline:
- Code of Federal Regulations 1979, title 16, § 1500.41, adapted to OECD TG404. - 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
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- 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 six rabbits at the examinations 30 minutes, 24, 48 or 72 hours after termination of exposure. This result was obtained for test sites of intact as well as abraded skin.
- Other effects:
- No other effects.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material pullulanase is not irritating to skin.
- Executive summary:
The acute dermal irritant effect of pullulanase was investigated according to the guideline Code of Federal Regulations 1979, title 16, § 1500.41 and adapted to OECD TG404 (1981) “Acute Dermal Irritation/Corrosion”. The study was conducted in accordance with GLP.
The study was performed on three male and three female albino rabbits, Danish Landstrain. They were each exposed to 0.5 g of the test material, moistened with saline, applied under semiocclusive conditions to each of the closely-clipped intact and abraded test sites (2.5 x 2.5 cm) on the back.
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 erythema, eschar formation or oedema was observed at any of the test sites at any of the examinations.
In conclusion, pullulanase was not irritating to skin and shall be classified as non-irritant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 08 - July 27, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to GLP and the procedures were according to the Code of Federal Regulations, title 16 § 1500.42 and adapted to OECD TG405 (1981).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal regulations, title 16, § 1500.42
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Danish Landstrain
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novo Industri, Denmark
- Weight at study initiation: between 2.7-3.2 kg
- Housing: Individually, in animal room with control of temperature (18-22°C) and relative humidity (30-35%)
- Diet : Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs)
- Water (e.g. ad libitum): tap water ad libitum
IN-LIFE DATES: From: 1982-06-08 To: 1982-06-11 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Test batch used as is:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg into the left eye - Duration of treatment / exposure:
- The test material was applied to the conjunctivel sac, no further action done, i.e. no washing.
- Observation period (in vivo):
- The reactions were judged 1, 24, 48 and 72 hours 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 at 1, 24, 48 and 72 hours after instillation according to the guideline. - Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- 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. Diffuse redness (3 rabbits, score 2), slight redness (3 rabbits, score 1) and slight chemosis (3 rabbits, score 1) were observed after 1 hour. After 24 hours only mild redness was seen in 2 rabbits (score 1). All signs were reversible, and no reactions were seen at the 48-hour reading.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, pullulanase can be classified as a ‘non irritant’ to the eye.
- Executive summary:
In accordance with the OECD guideline 405, a test for eye irritation in rabbits was performed with Pullulanase, batch PPY1323.
The eyes of six animals were checked for defects or irritation before instillation and only animals without defects were used.
100 mg of Pullulanase, batch PPY1323, was placed in the conjunctival sac of the left eye by pulling the lower eyelid away from the eyeball. The lids were gently held together for about one second after instillation. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the specified guideline.
No corneal opacity or iris reactions were noted at any time during the test. Diffuse or slight redness (max score 2) and slight chemosis (max score 1) were observed after 1 hour. After 24 hours only mild redness was seen in 2 rabbits (score 1). All signs were reversible, and no reactions were seen at the 48-hour reading.
In conclusion, pullulanase can be classified as a 'non-irritant' to the eye.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin and eye irritation potential of pullulanase has been tested according to OECD guidelines, and in compliance with GLP. No reactions at all were seen in the skin irritation study. In the eye irritation study, only transient conjunctival redness with or without swelling were seen. All reactions were mild, no scores were above 1. All effects in the eye irritation study cleared before the 48h reading.
The conclusion was that pullulanase did not exert any skin and eye irritation.
Justification for classification or non-classification
The skin and eye irritation potential of pullulanase has been tested according to OECD guidelines, and in compliance with GLP. The conclusion was that pullulanase did not exert any skin and eye irritation and therefore pullulanase should not be classifed.
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