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EC number: 263-462-4 | CAS number: 62213-14-3
- 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
Beta-glucanase was tested for skin and eye irritation in rabbits.
- Under the conditions of this test and criterta of the EEC Guidelines Pentopan/Biofeed Plus, batch PPC 5569 should not be classified as an eye irritant.
- The instillation of 0.1 mL Pentopan/Biofeed Plus to the conjunctival sac of 3 rabbits caused no signs of eye irritation, and therefore, under the conditions of the EEC Guidelines is not to be classified.
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:
- 10-04-1991 to 12-07-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC. Acute Toxicity (Skin irritation). Section 84 (L383A/124-L383A/127) of the Annex to the European Communities Directive 92/69/EEC. The Official Journal of the European communities L383A (vol. 35).
- Version / remarks:
- 1992
- Deviations:
- no
- 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 Nordisk A/S)
- Age at study initiation: 20-21 weeks
- Weight at study initiation: 2.9-3.1 kg
- Housing: The animals were housed individually in plastic cages with mesh floor (Scanbur).
- Diet (e.g. ad libitum): The animals were fed 130 g daily of a standard diet (Altromin 2110, Standard Diet for Rabbits).
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 animals
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3'C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): A light cycle of 12 hours light and 12 hours darkness was controlled automatically.
IN-LIFE DATES: From: 1996-04-16 To: 1996-05-22 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- 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): used as is - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 0.5-1, 24, 48, 72 hours after treatment. If skin reactions were observed, further assessments were conducted up to 21 days after test material application to determine the reversibility of the reactions.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: 0.5 mL of test material was applied to the intact skin on each rabbit under 2.5 cm x 2.5 cm patch of gauze. The patch was covered with 3M Micropore Surgical tape 1530-3 to make a semi occlusive bandage. Furthermore an elastic tubular support bandage was applied to prevent the rabbit from damaging the patch.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The patches were removed gently and the remaining test substance washed off with water.
- Time after start of exposure: Exposure time 4 hours
SCORING SYSTEM:
- Method of calculation:
Erythema and eschar formation
No erythema ...........................................................................................................................0
Very slight erythema (barely perceptible) ..............................................................................1
Well defined erythema ............................................................................................................2
Moderate to severe erythema ................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in depth) ...................4
Oedema formation
No oedema ..............................................................................................................................0
Very slight oedema (barely perceptible) .................................................................................1
Slight oedema (edges of area well defined by definite raising) ..............................................2
Moderate oedema (raised approximately 1 mm) ......................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) ..............4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4-5 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All symptoms were fully reversible within 4-5 days after exposure.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test and criterta of the EEC Guidelines Pentopan/Biofeed Plus, batch PPC 5569 should not be classified as a skin irritant.
- Executive summary:
A test for skin irritation in rabbits was performed with Pentopan/Biofeed Plus, batch PPC 5569 in accordance with OECD Guideline No. 404 and EEC Directive 1992.
0.5 mL test substance was applied once under a semi occlusive bandage to the shaved back skin of each of 3 rabbits. The length of exposure was 4 hours. The primary skin irritation was evaluated 0.5-1, 24, 48 and 72 hours after removal of the test substance. Irritation was not observed and neither were any clinical reaction to treatment recorded.
Under the test conditions employed, Pentopan/Biofeed Plus was non irritant to rabbit skin and should not be classified as a skin 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 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:
- 10-04-1996 to 16-08-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Novozymes A/S (previously Novozymes A/S)
- Age at study initiation: 21-23 weeks
- Weight at study initiation: 12.8-3.0 kg
- Housing: The animals were housed individually in plastic cages with mesh floor (Scanbur). - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The lower lid of the left eye was gently pulled away from the eye ball and 0.1 mL of the test substance was placed in the conjunctiva! sac. The lids were gently held together for approximately 1 second. The untreated eye served as a control.
- Concentration (if solution): Undiluted test sample. - Duration of treatment / exposure:
- The lids were gently held together for approximately 1 second.
- Observation period (in vivo):
- 1, 24, 48, 72 hours.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: Few seconds.
SCORING SYSTEM: The ocular irritation scores were classified in accordance with the EEC Directive. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- tear flow
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation at any time point.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The instillation of 0.1 mL Pentopan/Biofeed Plus to the conjunctival sac of 3 rabbits caused no signs of eye irritation, and therefore, under the conditions of the EEC Guidelines is not to be classified.
- Executive summary:
A test for eye initation in rabbits was performed with Pentopan/Biofeed Plus, batch PPC 5569 in accordance with OECD Guideline No. 405 and adapted to the EEC Directive.
The instillation of 0.1 mL of the test substance to the conjunctival sac of 3 rabbits elicited no reactions on cornea, iris or conjunctiva.
Under the conditions of this test and the criteria of EEC guideline Pentopan/Biofeed Plus, batch PPC 5569, should not be classified.
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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