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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-04-20 to 1982-06-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test method was proposed by OECD Guidelines for Testing Chemicals and evaluation made according to the Code of Federal Regulations, title 16, §1500.42.
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: OECD Guidelines for Testing Chemicals and evaluation made according to the Code of Federal Regulations, title 16, §1500.42.
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP equivalent at the time where the conduct of the study was subject to appropriate inspection by the quality assurance unit.
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:
- 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:
- 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:
- 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:
- solid: particulate/powder
- Details on test material:
- - Lot/batch No.: PPR 1289
- 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 / tissue source
- Species:
- rabbit
- Strain:
- other: Danish Landstrain
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: 2.9-3.2 kg
- Housing: Individually in galvanized steel cages with mesh floors and automatic watering
- Diet (e.g. ad libitum): Standard diet (Ewos Brood Stock Feed for Rabbits and Guinea Pigs).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 35%
IN-LIFE DATES: From: 1982-04-20 To: 1982-04-23
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Test batch used as is:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL into the left eye - Duration of treatment / exposure:
- 0.1 mL of the test substance was installed into the left eye of each rabbit by gently pulling the lower lid away from the eye ball, and the test substance was carefully introduced into the resulting cup. The lids were then gently held together for one second.
The right eye, remaining untreated, served as a control. - Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 6 rabbits (3 female + 3 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the Code of Federal Regulations, title 16 §1500.42
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: #1, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Ulceration
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal opacity or iris reactions were noted at any time during the test. Mild redness and slight chemosis were seen in all of the rabbits estimated at 1 hour.
At 24 hours mild redness was seen in 1 rabbit.
Both observed reactions were fully reversible and at 48 and 72 hours no conjunctival reactions were seen in any of the rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Not classified, Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, Rennilase SP 252 was regarded as negative to potential for eye injury.
- Executive summary:
In accordance with the proposed test method by OECD Guidelines for Testing Chemicals and with the evaluation conducted according to the Code of Fereral Regulation, title 1500.42, a test for eye irritation in rabbits was performed with rennilase SP 252, batch PPR 1289.
0.1 mL of rennilase SP 252, batch PPR 1289 was placed in the conjunctival sac of the left eye of six rabbits by pulling the lower eyelid away from the eyeball. The lids were gently held together for about one second after instillation. The untreated eye served as control. The ocular reactions were recorded at 1, 24, 48 and 72 hours after instillation according to the specified guideline.
No corneal opacity or iris reactions were noted at any time during the test. Mild redness and slight chemosis were seen in all of the rabbits estimated at 1 hour. At 24 hours mild redness was seen in 1 rabbit. At 48 and 72 hours no conjunctival reactions were seen in any of the rabbits.
In conclusion, rennilase SP 252 was classified as a 'non-irritant' to the rabbit eye.
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