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EC number: 253-446-5 | CAS number: 37288-54-3
- 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:
- November 5, 2002 – November 8, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Active enzyme protein of mannan endo-1,4-beta-mannosidase (EC no. 253-446-5, CAS no. 37288-54-3, EC name: Mannanase, endo-1,4-.beta.-, Enzyme Class No.: 3.2.1.78)
- Molecular formula:
- Not applicable, see remarks
- IUPAC Name:
- Active enzyme protein of mannan endo-1,4-beta-mannosidase (EC no. 253-446-5, CAS no. 37288-54-3, EC name: Mannanase, endo-1,4-.beta.-, Enzyme Class No.: 3.2.1.78)
- 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:
- -Substance type: UVCB
-Physical state: liqiud
-Storage: The test article was stored in the freezer and the refrigerator
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:
- Animals were procured from Millbrook Breeding Labs, Amherst MA 10/23/02. Three healthy animals were selected after an equilibration period of at least five days. The test animals were born the week of August 4th, 2002 and pre-test body weights ranged from 2.3 to 2.5 kg.
Animals were identified by cage notation and metal ear tags. Animals were each housed in a separate suspended wire cage. Bedding was placed beneath each cage and changed at least three times per week. Fresh food (PMI Rabbit Chow Diet #5321) was provided daily. Water was freely available at all times. The animal room was used only for actue testing on rabbits. The room was temperature and humidity controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test article was used as received.
- Controls:
- no
- Amount / concentration applied:
- The test article was dosed by volume at 0.5 mL per rabbit.
- Duration of treatment / exposure:
- The test area was covered with a 4 ply surgical gauze patch and the torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape. The test article was kept in contact with the skin for 4 hours, at which time the wrappings were removed.
- Observation period:
- Observation of any dermal reactions were recorded at 1, 24, 48 and 72 hours after patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.
- Number of animals:
- Three (two males and one female)
- Details on study design:
- The dorsal area of the trunk of each animal was clipped free of hair on the day prior to the application of the test article. The site of administration was approximately 2.5 cm x 2.5 cm. The test article was dosed by volume at 0.5 mL per rabbit. The test area was covered with a 4 ply surgical gauze patch and the torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape. The test article was kept in contact with the skin for 4 hours, at which time the wrappings were removed. Observation of any dermal reactions were recorded at 1, 24, 48 and 72 hours after patch removal. Residual test article was removed from the test site by gentle washing with distilled water prior to scoring observations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No erythema observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No erythema observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No erythema observed.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No edema observed.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No edema observed.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: Not applicable. No edema observed.
- Irritant / corrosive response data:
- There were no erythema or edema noted. There were no overt signs of systemic toxicity. The Primary Irritation Score was determined to be 0.
- Other effects:
- None.
Any other information on results incl. tables
Systemic observations were also made at 1, 24, 48, and 72 hours after patch removal. All observations were normal at all time points in all test animals. There were no abnormal clinical signs observed and all body weight changes were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article is not irritating to skin. Mannanase shall be classified as 'Non Irritant'.
- Executive summary:
Three New Zealand White rabbits (2 males : 1 female) were used. The test article (0.5 mL) was applied to one intact dermal site/rabbit. The test article was kept in contact with the skin for 4 hours, at which time the wrappings were removed. Dermal reactions were scored at 1, 24, 48 and 72 hours after patch removal. There were no erythema or edema noted at any time during the study period. There were no overt signs of systemic toxicity. The Primary Irritation Score was determined to be 0 and mannanase shall be classified as 'Non Irritant'.
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