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EC number: 939-154-7 | CAS number: -
- 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:
- other: read-across from supporting substances (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Literature data
Data source
Reference
- Reference Type:
- publication
- Title:
- Interspecies variations in response to topical application of selected zinc compounds.
- Author:
- Lansdown A. B. G
- Year:
- 1 991
- Bibliographic source:
- Fd Chem. Toxic. Vol. 29, No. 1, pp. 57-64, 1991
Materials and methods
- Principles of method if other than guideline:
- The dermal irritancy of the substance was examined in three animal models. Macroscopic skin reactions, skin histological changes and epidermal keratin binding of the test material were observed after 5 d application to skin using open patch test.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- mouse
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Animals: TO (outbred) and AG2 (inbred)
- Breeding: aminals were bred under barrier-maintained specified pathogen-free conditions at the Chafing Cross and Westminster Medical School. Male mice
- Age at study initiation: 8-10 wk old
- Diet: complete rodent diet (CRM, Biosure, Cambridge, UK)
- Water: deionized water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C
- Humidity: 55%
- Photoperiod: 12-h light/dark cycle
Test system
- Type of coverage:
- open
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- The concentrations used were those that had been shown to be non-irritant in preliminary acute studies in white (TO) mice (mice back skin was treated with 0.5 ml of the test compound at 0.1, 1.0, 10 or 20% and examined for erythema after 24 hr).
TEST SOLUTION
Test concentration: 1% (w/v)
Test solution was prepared 24 hr before use and stored at 4°C. The pH of each preparation was measured immediately before application. - Duration of treatment / exposure:
- 5 days
- Observation period:
- 5 days post exposure
- Number of animals:
- 8 groups of 6 animals, for open patch
- Details on study design:
- 1) OPEN PATCH TEST:
TEST SITE
- Area of exposure: test sites (5 cm^2) were prepared in the mid-dorsal regions.
- Preparation test area: the hair coat was clipped closely and the skin cleansed with 70% alcohol and allowed to dry before treatment.
Animals were gently anaesthetized with ether until the test sites had dried.
SACRIFICE
24 h after the fifth daily treatment, animals were sacrificed and representative samples of each test and control skin sites were preserved in 10 % phosphate buffered formalin for histology. Thin sections cut along the anterior-posterior axis were stained with haematoxylin and eosin, or with morin dye, which fluoresces blue-green in the presence of zinc ions and ultraviolet light (to demonstrate zinc binding to epidermal keratin histologically).
2) EPIDERMAL CELL KINETICS:
The influence on the mitotic behaviour of the dorsal skin epidermis was examined.
The experiment was set up identically to the mouse experiment, except that groups of 5 A2G mice were used for each treatment regimen.
Twenty-four hr after the final treatment, each mouse received a single ip injection of 0.1 mg vincristine (Oncovin, Lilly, Basingstoke, Hants., UK) in 0.25 ml of normal saline (Bullough and Laurence, 1966).
The animals were killed by cervical dislocation after 4 hr and three strips of skin from the treatment sites were preserved in 10% formalin for histological examination. Sections were stained with haematoxylin and eosin, and arrested mitoses per 1000 cells were counted.
The mitotic index was calculated.
3) MICROBIOLOGY:
In view of the observation that certain compounds exhibit antibiotic properties, fresh skin samples were obtained from animals at the end of the experimental period. They were routinely smeared across sterile blood agar plates, incubated at 37°C, and examined for bacterial growths 24 hr later using standard criteria. Previous quality assurance studies have shown an absence of ectoparasites, mycoplasma and viral infections in animals bred and maintained in the animal facility of the Charing Cross and Westminster Medical School.
Results and discussion
In vivo
Results
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Slight irritation (lower level of erythema) was observed in two out of six test animals after 5 d exposure. No reactions were observed in control group.
- Macroscopic observations in mouse skin exposed for 5 days: slight irritancy. Hair regrowth was possibly more advanced in sulphate.
- Histological changes in the skin following application in open patch tests: no evidence of damage.
- Morin fluorescence in skin: slight irritancy.
- Influence on epidermal cell proliferation in mouse skin: not significantly different from control group.
- Microbiology in the skin following treatment: Staphylococcus epidermidis and α-haemolytic streptococci. Animals treated with test substance induced negligible evidence of irritancy of epithelial hyperplasia.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Not irritating
- Executive summary:
The dermal irritancy of Similar Substance 01 was examined in three animal models. Macroscopic skin reactions, skin histological changes and epidermal keratin binding of the test material were not observed after 5 d application to skin using open patch test.
Conslusion
No statistically significant epidermal hyperplasia in normal skin following topical application was observed.
Substance can be considered to be non-irritant.
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