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EC number: 822-334-3 | CAS number: 52233-31-5
- 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
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Remarks:
- Skin irritation in humans
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 6 - 17 Mar 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure was a human volunteer study according to Kligman and Wooding (1967). The study was performed before GLP or GCP was implemented but was performed according to state of t he art at that time.
Data source
Reference
- Reference Type:
- other: Synopsis
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Test procedure was according to Kligman AM and Wooding WM : A method for the measurement and evaluation of irritants of human skin, Journal of Investigative Dermatology, 1967; 49 : 78-94: The cumulative irritation to the skin was measured by a patch-test technique on intact skin of the volar forearms of 10 subjects. Under a square patch measuring 1 inch by 1 inch, 0.5 mL of the test substance was applied to the skin. The patches were secured in place by occlusive tape. Twenty-four hours after patch application, the test site was clinically evaluated and a new patch applied. The test was repeated for 10 days.
- GLP compliance:
- no
- Remarks:
- ; before GLP or GCP but according to the same principles
Test material
- Reference substance name:
- Subtilisin
- EC Number:
- 232-752-2
- EC Name:
- Subtilisin
- Cas Number:
- 9014-01-1
- Molecular formula:
- Not applicable, please see remarks.
- IUPAC Name:
- Subtilisin
Constituent 1
Method
- Details on study design:
- For the test 4 females and 6 males (age 18 - 45 years, white) The cumulative irritation to the skin was measured by a patch-test technique on intact skin of the volar forearms of 10 subjects. Under a square patch measuring 1 inch by 1 inch, 0.5 mL of a 1% solution in water of the test substance Subtilisin was applied to the skin (Concentration: 0.14% expressed as active enzyme protein). The patches were secured in place by occlusive tape. 24 h after each patch application, the test site was clinically evaluated and a new patch applied. The test was repeated for 10 days including daily readings.
Results and discussion
- Results:
- The mean primary skin irritation of 10 humans (Time points Days 1-10) was 0, as no human primary skin irritation was observed at all after application of subtilisin (1%, in water).
Applicant's summary and conclusion
- Conclusions:
- It is concluded that it is unlikely that the present test material (1% solution in water) would present a risk of primary skin irritation for humans under normal use conditions. Therefore it is regarded as not irritant (criteria used for interpretation of results: expert judgment)
- Executive summary:
An in vivo human skin irritation test was conducted to assess the potential of the test substance, subtilisin, to cause cumulative skin irritation. The procedure of Kligman AM and Wooding WM: A method for the measurement and evaluation of irritants of human skin, Journal of Investigative Dermatology, 1967; 49 : 78-94, was followed. Under a square patch measuring 1 inch by 1 inch, 0.5 mL of the test substance was applied to the intact skinof the volar forearms of 10 subjects. The patches were secured in place by occlusive tape. Twenty-four hours after each patch application, the test site was clinically evaluated and a new patch applied. The test was repeated for 10 days with reading every day. The study was conducted before GLP or GCP was implemented but the state of the art of the time of the study was followed. The study concluded that it is unlikely that the present test material (1% subtilisin solution in water, 0.14% expressed as active enzyme protein) would present a risk of primary skin irritation for humans under normal use conditions.
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