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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-671-2 | CAS number: 9004-07-3
- 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
Endpoint summary
Administrative data
Description of key information
Protease 10R was tested for skin and eye irritation.
- 10R Protease, batch PPA 26797 was examined for skin irritation in the Episkin in vitro assay for skin irritation. Protease 10R, PPA 26797 was found to be a skin irritant.
- 10R Protease batch PPA 26797 was tested on rabbit skin. According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, PPA 26797 is irritating (R38) to (human) skin. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, PPA 26797 is also irritating (Category 2) to (human) skin.
-10R Protease, batch PPA 26797 was tested for acute eye irritating properties in an experiment with three albino rabbits. At 48 h after treatment, any eye effects had cleared completely.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, PPA 26797 is not irritating to eyes. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, PPA 26797 is also not irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03-08-2007 to 09-11-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Adopted on 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Not necessary since they are reconstructed skin membranes
- Remarks:
- SPF bred New Zealand White albino rabbits.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): used as is (9.5% TOS) - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 1, 24, 48, 72 hours and at 7 and 14 days after treatment.
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: The test substance was distributed over a cotton gauze patch. The patch loaded with the test substance was fixed to the selected application site by means of semi-occlusive, adhesive tape. Subsequently, the entire trunk of the rabbit was wrapped with a self-adhesive-gauze to maintain the patch in position and to retard evaporation of volatile substances.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test site was cleaned with a tissue moistened with water.
- Time after start of exposure: Exposure time 4 hours. Observation period post-exposure: 1, 24, 48, 72 hours and at 7 and 14 days.
SCORING SYSTEM:
- Method of calculation: The resulting skin reactions were evaluated by the method of Draize et al. (J. Pharrnacol. Exp. Ther. 82 (1944) 377-390. - Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, batch PPA26797 is irritating (R38) to (human) skin. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, batch PPA26797 is also irritating (Category 2) to (human) skin.
- Executive summary:
A sample of 10R Protease, PPA 26797 was tested for acute dermal irritating properties in an experiment with three albino rabbits, according to EC Directive 92/69/EC, method B.4 and OECD Guideline no. 404. 10R Protease, batch PPA26797 caused very slight to moderate erythema, moderate incrustation and very slight to moderate oedema. At 14 days after treatment, all dermal effects had cleared completely.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, batch PPA26797 is irritating (R38) to (human) skin. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, PPA 26797 is also irritating (Category 2) to (human) skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-06-2008 to 04-07-2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Not stated.
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Remarks:
- Episkin Standard Model (Episkin-SM)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN PREPARATION
- Procedure used: The ECVAM Skin Irritation Validation Study protocol was followed. Episkin Standard Model (Episkin-SM), 12 tissue inserts of each 0.38cm^2, including maintainace medium provided by SkinEthic.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37ºC and 5% CO2
- Temperature of post-treatment incubation (if applicable): Same
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: each skin model was removed from the well, rinsed with 25 mL PBS to remove the study substance, and blotted dry.
- Observable damage in the tissue due to washing: None
- Modifications to validated SOP: None
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: Yes, but not specified.
- Wavelength: 575 nm
- Filter: Not specified
- Filter bandwidth: Not specified
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
The acceptance criteria for a valid test;
* The mean OD value for the three NC tissue is >= 0.6 and the standard deviation value (SD) of the viability is<= 18
* The mean viability for the positive control (SDS treated) expressed as % of the NC, is below or 30% and the SD is <= 18 - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 μL, 26.3 μL/cm^2
- Concentration (if solution): used as is (9.5% TOS) - Duration of treatment / exposure:
- 15 min.
- Duration of post-treatment incubation (if applicable):
- 42 hours.
- Number of replicates:
- Triplicate tissues each for test substance, negative control Phosphate Buffered Saline and positive control 5% Sodium Dodecyl Sulphate.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 43.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: No reduction was observed.
- Colour interference with MTT: None observed.
The acceptance criteria for a valid test:
* The mean OD value for the three NC tissue is >= 0.6 and the standard deviation value (SD) of the viability is <= 18
* The mean viability for the positive control (SDS treated) expressed as % of the NC, is below or 30% and the SD is <= 18 - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- 10R Protease, PPA 26797 was examined for skin irritation in the Episkin in vitro assay for skin irritation. Protease 10R, PPA 26797 was found to be a skin irritant.
- Executive summary:
10R Protease, batch PPA26797 was examined for skin irritation in the Episkin in vitro assay for skin irritation. The ECVAM Skin Irritation Validation Study protocol was followed. The results of the present test were within the acceptance criteria for a valid test. Protease 10R, batch PPA26797 was found to be a skin irritant.
In conclusion, Protease 10R is classified as irritant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-09-2007 to 13-11-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted on 24 April 2002.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF bred New Zealand White albino rabbits.
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: Males, young adult
- Weight at study initiation: 1966, 1936 and 2106 g
- Housing: Individually in stainless steel cages with perforated floor. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The chicken eye cornea was treated with 0.1 mL.
- Concentration (if solution): Undiluted test sample, 9.5% TOS. - Duration of treatment / exposure:
- After administration, the upper and lower eye lid were carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.
- Observation period (in vivo):
- 1, 24, 48, 72 hours.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: few seconds
SCORING SYSTEM: The acute irritation of the test sample was classified according to the EC criteria for the labelling and classification of dangerous substances, as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993 and to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003). - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 10R Protease, batch PPA26797 was tested for acute eye irritating properties in an experiment with three albino rabbits. At 48 h after treatment, any eye effects had cleared completely.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, batch PPA26797 was not irritating to eyes. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, PPA 26797 was also not irritating to eyes. - Executive summary:
10R Protease, batch PPA26797 was tested for acute eye irritating properties in an experiment with three albino rabbits, according to EC Directive 92/69/EC, method B.5 and OECD Guideline no. 405.
10R Protease, batch PPA26797 caused slight redness and slight or moderate swelling of the conjunctivae and slight ocular discharge in the three rabbits. At 48 h after treatment, all eye effects had cleared completely.
According to the EC-standards (as published in the Official Journal of the European Communities, L 110 A, Volume 36, 4 May 1993), 10R Protease, PPA 26797 was not irritating to (human) eyes. According to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS; UN/ECE 2003) 10R Protease, batch PPA26797 was also not irritating to (human) eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Chymotrypsin is classified as a Category 2 irritant to the skin.
Chymotrypsin is not classified as an irritant to the eye.
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.