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EC number: 629-845-9 | CAS number: 9001-89-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Active enzyme of 4-phytase (CAS 9001-89-2, IUBMB 3.1.3.26)
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- Active enzyme of 4-phytase (CAS 9001-89-2, IUBMB 3.1.3.26)
- 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:
- 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:
- 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:
- 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:
- % Total Organic Solids: 25.27%
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- other: HanTac:WH (Wistar Hannover GALAS)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Europe A/S, DK-4623 Lille Skensved, Denmark
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 149 - 160 g
- Fasting period before study: overnight
- Housing: The animals were kept in transparent polycarbonate cages (floor area: 1500 cm² Height 21cm) with two in each cage. The cages were cleaned and the bedding changed at least twice a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C ±3°C
- Humidity (%): 55% ±15%.
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): cycle of 12 hours light and 12 hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION: The test item was thawed in the refrigerator (+2 - +8°C) overnight. According to the Sponsor, the test item formulation was stable for at least 7 days when stored at +2 - +8°C in the dark. The dose formulation was the undiluted test item.
MAXIMUM DOSE VOLUME APPLIED: Dose volume was 8.09 mL/kg of the undiluted test item.
The starting dose level was based on information from the Sponsor. One female animal was treated with 2000 mg total protein/kg body weight. As no evident signs of toxicity were observed in the animal, the main study was carried out at this dose level. - Doses:
- 2000 mg total protein/kg body weight (equivalent to of 2143.32 mg enzyme concentrate dry matter/kg bw or 1264.74 mg active enzyme protein/kg bw)
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed 15 minutes and 1, 3, and 6 hours after administration and daily thereafter for 14 consecutive days for clinical signs and weight measured on Days 1, 2, 3, 8, and 15.
- Necropsy of survivors performed: yes
Food was withheld for a 3-hour period after treatment.
Results and discussion
- Preliminary study:
- One female was dosed at 2000 mg total protein/kg body weight. Animal gained weight during study. No clinical signs were observed. No abnormalities in post-mortem inspection. The preliminary study animal was included in the main study.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 1 264.74 mg/kg bw
- Based on:
- other: active enzyme protein
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 143.32 mg/kg bw
- Based on:
- other: enzyme concentrate dry matter
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- No signs of toxicity were observed among the 5 animals treated with 2000 mg total protein/kg body weight (equivalent to of 2143.32 mg enzyme concentrate dry matter/kg bw or 1264.74 mg active enzyme protein/kg bw)
- Executive summary:
The objective of this study was to assess the toxicity of the test substance when administered as a single oral dose followed by an observation period of 14 days. The study was conducted in accordance with OECD Guideline 420. The study was initiated with a sighting study using one female animal. The dose volume administered was 8.09 mL/kg of the undiluted test item, corresponding to 2000 mg total protein/kg body weight.
On the basis of the results of the sighting study, the main study was performed in four additional female rats given a dose of 2000 mg total protein/kg body weight. The total number of animals in the main study included the female animal treated at the same dose level (2000 mg total protein/kg body weight) in the sighting study. No clinical signs were observed among the animals and the body weight gain during the study was normal. The post-mortem inspection of the animals treated with 2000 mg total protein/kg body weight revealed no abnormalities. The dose of 2000 mg total protein/kg body weight is equivalent to of 2143.32 mg enzyme concentrate dry matter/kg bw or 1264.74 mg active enzyme protein/kg bw.
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