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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
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Active enzyme protein of Beta-glucanase, endo-1,3(4) (CAS no, EC no., EC name endo-1,3(4)-beta-glucanase, enzyme class 3.2.1.6)
- Molecular formula:
- Not applicable
- IUPAC Name:
- Active enzyme protein of Beta-glucanase, endo-1,3(4) (CAS no, EC no., EC name endo-1,3(4)-beta-glucanase, enzyme class 3.2.1.6)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Details on test material:
- - Lot/batch No.: PPC 5569
- Expiration date of the lot/batch: December 2006
- Storage condition of test material: Frozen in the dark
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
- 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.
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