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EC number: 232-802-3 | CAS number: 9025-67-6
- 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:
- 20-03-1982 to 29-03-1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Toxic Substances Control Act, George Dominquez, 1977
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Inulinase
- EC Number:
- 232-802-3
- EC Name:
- Inulinase
- Cas Number:
- 9025-67-6
- Molecular formula:
- n.a.
- IUPAC Name:
- Inulinase
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Lot/batch No.: PPZ1281
- Expiration date of the lot/batch: April 1993
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novozymes A/S (previously known as Novo Industri A/S)
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Not stated
- Weight at study initiation: 18-22 g
- Fasting period before study: 18 hour fasting prior to dosing
- Housing: Barriered rodent facility with control of temperature, humidity and lighting. The cages were solid bottomed polycarbonate cages with a stainless steel mesh lid. Softwood bark-free fibre were provided as bedding. Aspen chew block and plastic shelter for environmental enrichment.
- Diet: standard diet (Brood Stock Feed for Rats and Mice - R3 - Astra Ewos) ad libitum
- Water: tap water (adjusted to approximately pH 3.0 with citric acid) ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 45-70%
IN-LIFE DATES: From: 1982-01-20 To: 1982-02-04
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Undiluted test material for the top dose.
- Doses:
- Doses were 1000, 2000, 5000, 15000 mL/kg bodyweight.
- No. of animals per sex per dose:
- Three groups of 5 male and 5 female and 2 groups of 2 male and 2 female NMRI mice.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days.
- Frequency of observations and weighing: Thirty minutes after dosing and daily in the following 9 or 15 days the mice were observed for any signs of reaction. The body weight was recorded just before dosing day 1 (all groups) and day 8 (group 1, 4 and 5), but due to a mistake no body weights were recorded day 15 before sacrifice.
- Necropsy of survivors performed: A macroscopic post mortem examina.tion was perforrned on all mice. - Statistics:
- Body weight and body weight gain were subjected to statistical anal ysis using Student's t-test comparing group 1 (control) with group 4 and 5.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 15 000 mg/kg bw
- Based on:
- other: Total Organic Solids (TOS)
- Mortality:
- No deaths or clinical symptoms were seen at anytime during the observation period.
- Clinical signs:
- No clinical symptoms were seen at anytime during the observation period.
- Body weight:
- A decrease in body weight and body weight gain was seen in males given the highest dose, 15000 mg/kg, as the only intergroup difference.
- Gross pathology:
- No dose related macroscopic findings were seen in any of the mice.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No deaths clinical symptoms or macroscopic findings were seen in any of the mice, but a decrease in body weight gain was seen in the highest dosed males.
As no deaths occured the LD50 value was estimated to be over 15000 mg/kg for both males and females and Novozym 230 could be classified "relatively harmless" according to Guidebook: Toxic Substances Control Act, George Dorninquez, 1977. - Executive summary:
The objective of this study was to evaluate the acute oral toxicity in mice of the enzyme Novozym 230 (batch PPZ1281). The test substance was dissolved in tap water and given once orally in doses of 0, 1000 , 2000, 5000 and 15000 mg/kg body weight to groups of 2 or 5 male and 2 or 5 female NMRI mice. Thirty minutes after dosing and daily in the following 9 or 15 days, the mice were observed for any signs of reaction. The mice were weighed at weekly intervals. They were sacrificed at the end of the observation period and a macroscopic post mortem examination was performed on all the mice.
No deaths clinical symptoms or macroscopic findings were seen in any of the mice, but a decrease in body weight gain was seen in the highest dosed males.
As no deaths occured the LD50 value was estimated to be over 15000 mg/kg for both males and females and Novozym 230 could be classified "relatively harmless" according to Guidebook: Toxic Substances Control Act, George Dorninquez, 1977.
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