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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 21, 1991 to August 29, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Mannanase, endo-1,4-β-
- EC Number:
- 253-446-5
- EC Name:
- Mannanase, endo-1,4-β-
- Cas Number:
- 37288-54-3
- Molecular formula:
- Not available. See Remarks.
- IUPAC Name:
- mannan endo-1,4-beta-mannosidase IUBMB 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:
- 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
- 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
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Lot/batch No.: 91-001
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River U.K. Limited, Margate, Kent, England.
- Fasting period before dosing: Overnight prior to and approximately 4 hours after dosing.
- Housing: Five animals per cage, metal cages with wire mesh floors.
- Weight at time of dosing: Between 114-134 grams
- Housing: In animal room with control of temperature and humidity
- Diet: Standard diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: 8 days
- Temperature (°C): 20-22°C
- Humidity: 68% (mean daily relative humidity value)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- Diluted at a concentration of 50% w/v in distilled water.
- Doses:
- 3.32 g total protein/kg bogyweight, 10 mL/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days after dosing
- Frequency of observations and weighing: soon after dosing, every 5 hours for the remainder of the day of dosing, twice a day for the rest of the study period. Weighing on Day of dosing (Day 1), Day 8, and Day 15.
- Necropsy of survivors performed: yes (macroscopic post mortem examination) - Statistics:
- No
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3.32 other: g/kg bw
- Based on:
- other: Total protein
- Mortality:
- Male: 5 g/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5 g/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Pilo-erection was observed in all rats within two minutes after dosing and throughout the remainder of Day 1 (day of dosing). No clinical signs were observed by Day 2.
- Gross pathology:
- Effects on organs:
No treatment related findings were observed. Histopathology was not performed.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In conclusion, the acute oral lethal dosage (LD50) to rats of the present Mannanase enzyme, Mannase EM, was greater than 3.32 g total protein/kg bw.
- Executive summary:
The study was performed according to GLP and the procedures were according to EEC Methods for the determination of toxicity, Directive 84/449/EEC (OJ No. L251, 19.09.84), Part B, Method B.1. Acute Toxicity (oral).
The test item was supplied as a beige powder and was prepared at a concentration of 50% w/v in distilled water. The dose volume administered was 10 mL/kg.
The only clinical sign observed was piloerect coat in all rats within two minutes after dosing and throughout the remainder of Day 1 (day of dosing). No clinical signs were observed by Day 2. The overall body weight gain during the study was considered to be normal. The post-mortem inspection revealed no abnormalities.
In conclusion, the acute lethal oral dose to rats of the present mannanase enzyme, Mannase EM, was found to be greater than 3.32 g total protein/kg bw.
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