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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-05-11 to 1982-06-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP and according to the Code of Federal Regulations 1979, title 16, 1500.41 and adapted to OECD Guidelines for Testing Chemicals
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: Study conducted according to GLP and according to the Code of Federal Regulations 1979, title 16, 1500.41 and adapted to OECD Guidelines for Testing Chemicals.
- Version / remarks:
- 1979
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- GLP equivalent at the time. 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
- Species:
- rabbit
- Strain:
- other: Danish Landstrain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred by Novozymes A/S (previously Novo Industri A/S)
- Weight at study initiation: 2.9-3.3 kg
- Housing: Individually in galvanized steel cages with mesh floors and automatic watering
- Diet (e.g. ad libitum): Standard diet
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22°C
- Humidity (%): 40 - 50%
IN-LIFE DATES: From: 1982-05-11 To: 1982-05-14
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Remarks:
- Hair was clipped and skin abraded.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes, 24 hours, 48 hours and 72 hours.
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch by 1 inch
- Type of wrap if used: A coat of PVC
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30-60 minutes, 24 hours, 48 hours and 72 hours
SCORING SYSTEM:
Erythema and eschar formation
No erythema ....................................................................................................................................0
Very slight erythema (bar ely perceptible) ......................................................................................1
Well-defined erythema .....................................................................................................................2
Moderate to severe erythema ..........................................................................................................3
Severe erythema (beet redness) to slight eschar formations (injuries in the depth) ......................4
Edema formation
No edema ..........................................................................................................................................0
Very slight edema (bar ely perceptible) ............................................................................................1
Slight edema (edges of area well-defined by definite raising) .........................................................2
Moderate edema (raised approximately 1 millimeter) ........................................................................3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) ......... 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Two of the female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal. The reaction was reversible, and no signs were seen at the reading at 24 hours.
None of the other animals showed any signs of reaction to the test substance during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- The study was conducted according to the Code of Federal Regulations 1979, title 16 § 1500.41. Two of the six female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal, which gave a primary irritation score of 0.16. However, the reaction was fully reversible, and no signs were observed at the reading at 24 hours. The irritation score for the mean of 24, 48 and 72 hours was 0. Therefore, according to the current classification, rennilase SP 252 was classified as a "non irritant" to the skin.
- Executive summary:
The skin irritation effect of rennilase SP 252, batch PPR1289 was investigated according to the Code of Federal Regulations 1979, title 16 § 1500.41 and adapted to the OECD guidelines for testing of chemicals.
The study was performed on six rabbits. They were each exposed to 0.5 mL of the test material, applied under occlusive conditions to clipped intact and abraded skin (1 x 1 inch) on the back.
After a 4-hour exposure period, the test item was removed from the test site and the skin was examined after 30-60 minutes, 24 h, 48 h and 72 h.
Two of the six female animals (No. 5 and 6) revealed on the abraded area a very slight erythema evaluated 30-60 minutes after patch removal, which gave a primary irritation score of 0.16. However, the reaction was fully reversible, and no irritation signs were seen at the reading at 24 hours. The irritation score for the mean of 24, 48 and 72 hours was 0.
Therefore, according to the current classification, rennilase SP 252 was classified as a "non irritant" to the skin.
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