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EC number: 642-981-3 | CAS number: 148465-73-0
- 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:
- supporting study
- Study period:
- January 6, 1982 - March 15, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- - Principle of test: Acute toxicity of Rennilase SP 252 given once orally to rats followed by an observation period of 14 days.
- Short description of test conditions: The rats were deprived of food approximately 18 hours before dosing once orally by gavage. Rennilase SP 252 was dosed in 2.5 g/kg BW, 5 g/kg BW, 10 g/kg BW and 15 g/kg BW (equivalent to 2.4, 4.7, 9.5 and 14.2 g enzyme concentrate dry matter/kg BW). A control group was also included. All rats were carefully observed in the first two hours after dosing and daily in the following 14 days whereupon a gross post mortem examination was performed. All the rats were weighed on the day of dosing (day 1), on day 7 and on the day of termination (day 14).
- Parameters analysed / observed: Clinical observations, post mortem observations and body weight. - GLP compliance:
- no
- Remarks:
- Before GLP was established. Internal quality check was used under this study.
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Active enzyme protein of mucorpepsin (CAS no.148465-73-0, EC no 642-981-3, enzyme class 3.4.23.23)
- Molecular formula:
- Not applicable
- IUPAC Name:
- Active enzyme protein of mucorpepsin (CAS no.148465-73-0, EC no 642-981-3, enzyme class 3.4.23.23)
- 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.
- 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.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Lot/batch No.: PPR 1285
- Expiration date of the lot/batch: No specific expiry date. At least 10 years or as long as enzyme activity is preserved
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:
- TEST ANIMALS
- Source: Møllegaard Breeding Centre Ltd., Ejby, Denmark
- Females nulliparous and non-pregnant: Yes
- Weight at study initiation: 47 - 62 g
- Fasting period before study: approximately 18 hours before.
- Housing: Macrolon cages (Type IV)
- Diet: Ad libitum (Brood Stock Feed for Rats and Mice - R3 - Astra Ewos)
- Water: Ad libitum (Adjusted to pH 3 with citric acid)
ENVIRONMENTAL CONDITIONS
Not specified
IN-LIFE DATES: From: 1982-01-28 To: 1982-02-11
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 15 g/kg bw - Doses:
- 2.4, 4.7, 9.5 and 14.2 g enzyme concentrate dry matter/kg BW
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 day, 7 day and 14 day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: microscopic and microscopic examination. - Statistics:
- Body weights were compared between groups and no significant intergroup difference (p<0.05) was seen.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 14 200 mg/kg bw
- Based on:
- other: Enzyme concentrate dry matter
- Mortality:
- No animals died during the observation period.
- Clinical signs:
- other: No clinical signs were observed during the study period.
- Gross pathology:
- Two animals (1 in control and 1 in the group with highest dosage) showed pneumonia like areas, but microscopic findings omitted pneumonia. Perirenal edema was seen in animal from the control group.
- Other findings:
- Microscopic findings:
Control animal: In the lung, no abnormalities, only a slightly agonal blood aspiration. In the kidney, few degenerative tubuli in the outer zone of cortex predominantly due to pressure from the perirenal edema.
Animal from the highest dosage group: Agonal blood aspiration (no signs of inflammation).
Applicant's summary and conclusion
- Interpretation of results:
- other: Data adequate, but insufficient for classification
- Conclusions:
- Rennilase SP 252 did not cause any effects on Wistar rats administered a single oral dose of 14.2 g enzyme concentrate dry matter/kg bw (equivalent to 1356 mg active enzyme protein/kg bw) followed by a 14-day observation period. Therefore, it can be considered as relatively harmless (according to Guidebook: Toxic Substance Control Act, edited by George Dominquez and published by CRC Press, Inc. in 1977).
- Executive summary:
The object of this study was to evaluate the acute toxicity in rats of Rennilase SP 252, an enzyme of microbial origin. The test substance, a yellow-brown powder, was dissolved in tap water and given once orally in doses of 2.4, 4.7, 9.5 and 14.2 g enzyme concentrate dry matter/kg BW to groups of 10 male and 10 female Wistar rats. Tap water was given to another group of 10 male and 10 female Wistar rats as a control. The rats were carefully observed in the first two hours after dosing and subsequently daily in the following 14 days. On day 14 they were sacrificed and post mortem examined. The rats were weighed on the day of dosing, on day 7 and on the day of termination. No animals died during the study.
Rennilase SP 252 did not cause any effects on Wistar rats administered a single oral dose of 14.2 g enzyme concentrate dry matter/kg bw (equivalent to 1356 mg active enzyme protein/kg bw) followed by a 14-day observation period. Therefore, it was considered as relatively harmless (according to Guidebook: Toxic Substance Control Act, edited by George Dominquez and published by CRC Press, Inc. in 1977).
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