Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 232-734-4 | CAS number: 9012-54-8
- 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 September 20, 1994 to October 12, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to GLP and the procedures were according to the OECD test guideline 401 (1987).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex to Commission Directive 92/69/EEC of 31 July 1992. B1. L 383 A/110. OECD Guidelines for Testing of Chemicals, 401, 1987.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Active enzyme protein of Cellulase (EC no. 232-734-4, CAS no. 9012-54-8, EC name: Cellulase, Enzyme Class no. 3.2.1.4)
- Molecular formula:
- Not applicable, see remarks.
- IUPAC Name:
- Active enzyme protein of Cellulase (EC no. 232-734-4, CAS no. 9012-54-8, EC name: Cellulase, Enzyme Class no. 3.2.1.4)
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- 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.: PPC4795
- Expiration date of the lot/batch: June 2004
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Møllegaard Breeding Center, Ejby, Denmark.
- Fasting period before dosing: approximately 21 hrs overnight
- Housing: Five animals per cage, transparent polycarbonate cages Type IV, 590 MAK dimensions 59 x 38 x 20 cm
- Weight at time of dosing: between 112-121 g (males), 108- 127 g (females)
- Housing: In animal room with control of temperature and humidity
- Diet: Standard diet ad libitum
- Water: Acidified tap water ad libitum
- Acclimation period: 5 days
- Temperature (°C): 19-21°C
- Humidity : 33-80 %
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Test batch used as is. Control animals were dosed with tap water.
- Details on oral exposure:
- Undiluted test material, dose volume 20 mL/kg bw, corresponds to 2.96 g enzyme concentrate dry matter/kg body weight (limit test), based on the conservative assumption that the specific gravity of the undiluted test batch is 1 g/mL.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical signs of effect: Frequently during day 1 (dosing day) and then once a day. Weighing on Days 1, 8 and 15
- Animals were fasted from the evening before dosing and until 4 hrs after dosing
- Necropsy of survivors performed: yes - Statistics:
- No
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 960 mg/kg bw
- Based on:
- other: enzyme concentrate dry matter
- Mortality:
- Male: 2960 mg enzyme concentrate dry matter/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2960 mg enzyme concentrate dry matter/kg bw; Number of animals: 5; Number of deaths: 0
No control animals died during the study. - Clinical signs:
- other: Signs of toxicity related to dose levels: No clinical signs were observed in the dose group or in the control group.
- Gross pathology:
- Effects on organs:
No treatment related findings were observed in the dose group or the control group. Histopathology was not performed.
Applicant's summary and conclusion
- Interpretation of results:
- other: Data insufficient for classification as 2960 mg enzyme concentrate dry matter/kg bw corresponds to 1512 mg active enzyme protein matter/kg bw
- Conclusions:
- In conclusion, the acute oral lethal dosage (LD50) of cellulase was greater than 2960 mg enzyme concentrate dry matter/kg bw.
- Executive summary:
The study was conducted in accordance with the OECD Guideline No 401, “Acute Oral Toxicity”. The limit test procedure was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 20 mL/kg of the undiluted test material.
Five male and five female Wistar rats were dosed a volume of 20 mL/kg bw corrosponding to 2960 mg enzyme concentrate dry matter/kg bw. A control group was dosed with tap water at the same dose volume.
No clinical signs were observed and the overall body weight gain during the study was considered to be normal. The post-mortem inspection revealed no abnormalities.
In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 2960 mg enzyme concentrate dry matter/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.