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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-796-2 | CAS number: 9025-49-4
- 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:
- 2 006
- Report date:
- 2006
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 protein of Aspergillopepsin I (EC no. 232-796-2, CAS no. 9025-49-4, EC name: Proteinase, Aspergillus acid, Enzyme Class no. 3.4.23.18)
- Molecular formula:
- Not applicable, see remarks
- IUPAC Name:
- Active enzyme protein of Aspergillopepsin I (EC no. 232-796-2, CAS no. 9025-49-4, EC name: Proteinase, Aspergillus acid, Enzyme Class no. 3.4.23.18)
- 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:
- - Lot/batch No.: AFP501K1
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rat
- Strain:
- other: HanTac:WH
- Remarks:
- SPF (Specific Pathogen Free)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic M&B A/S, Dk-8680 Ry, Denmark
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: not reported
- Weight at study initiation: 140-151 g
- Fasting period before study: Overnight; after treatment, feed was withheld for a further 3 hours
- Housing: Transparent polycarbonate cages (macrolone type III, floor area 810 cm2). 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±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE: Distilled water
MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg body weight
DOSAGE PREPARATION (if unusual): Prior to use, the test substance was thawed in the refrigerator overnight. The test substance dose formulations were prepared by diluting the test substance with vehicle. The dose formulations were prepared on the respective days of treatment and stored at room temperature until used. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Remarks:
- For the animal welfare of the sighting study animal, a female companion animal was housed with the sighting study animal. The companion animal was observed for clinical behaviour and subjected to gross necropsy (results not included in report).
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were weighed prior to treatment on Day 1, and on Days 2, 3, 8, and 15; each rat was observed 15 minutes and 1, 3, and 6 hours after administration and thereafter daily for a period of 14 consecutive days.
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 other: mg total protein/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed during the study.
- Clinical signs:
- Sighting Study: At the observations 1 and 3 hours after treatment, the sighting animal appeared less active. Furthermore, the animal had piloerection 3 hours after treatment. However, the animal appeared normal at all other observations.
Main Study: At the observations 1, 3, and 6 hours after treatment, all animals had piloerection. At all other observations all 4 animals appeared normal. - Body weight:
- Sighting Study: The sighting animal had a normal body weight gain from treatment until termination of the study.
Main Study: All 4 animals had a normal body weight gain from treatment until termination of the study. - Gross pathology:
- No macroscopic abnormality of tissues or organs was noted at necropsy for the sighting study or the main study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50: >2000 mg total protein/kg bw
- Executive summary:
The acute oral toxicity of the test substance was studied in rats after administration of a single oral dose followed by an observation period of 14 days. A preliminary sighting study, using one female animal, was included in order to estimate the dose effect for toxicity and to provide information on dose selection for the main study. The study was conducted in accordance with OECD Guideline 420. The study was initiated with a sighting study in one female rat, in which 2000 mg total protein/kg body weight was examined in order to provide information on dose selection for the main study. On the basis of the results of the sighting study, the main study was performed in 4 additional female rats given a dose of 2000 mg total protein/kg body weight.
All animals survived the treatment. Slight signs of toxicity (piloerection and less activity) were observed among the animals on the day of treatment. However, no signs of toxicity were observed on any of the following days. All four animals had a normal body weight gain from treatment until termination of the study. The post-mortem inspection revealed no abnormalities. Under the experimental conditions, it was found that the minimal lethal dose of the test substance was above 2000 mg total protein/kg body weight.
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.