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EC number: 427-430-5 | CAS number: 54301-26-7
- 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:
- From 17 November 1997 to 07 December 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- UG
- IUPAC Name:
- UG
- Details on test material:
- • Identification, reference : UG batcli 97302300
• Appearance : white solid (pieces)
• Quantity received, packaging: 100 g, plastic box
• Date ofreceipt : November 10, 1997
• Laboratory reference: 97-369 1
• Analytical sheet: not supplied
• Homogeneity test: not required for less than 28 days studies
• Storage: at room temperature, away from the light and heat
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Species, strain, supplier : New-zealand albino rabbit, Charles RIVER (76110 Saint Aubin
Les Elbeuf France).
Reason for species selection : the New-zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities.
- Number and sex: 3 females
If strong effects are foreseeable, the test is performed in one animal. From the results obtained, the test may be flot realized in the two others.
- Average weight: 2.4 kg
- Identification: auricular ring
- Acclimatization : at ieast 5 days
- Housing, diet : environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individuai housing on floor grid). Complete peileted rabbit maintenance diet ERGILAP Anco, COFNA (37018 - TOURS, FRANCE).
- Preparation: approximately 24 hours before the test, fur is removed by clipping from the dorsal area of the trunk of the animais. Care is taken to avoid abrading the skin. Only animais with heaithy intact skin are used.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- The test material is applied under a semi-occlusive patch to the skin of the 3 rabbits at the dose of 0.5 g!rabbit according to the foilowing procedure
• 0.5 mi ofthe test material (previously pounded in a mostar) are appiied to the ciipped skin, then covered with a gauze (2.5 x 2.5 cm) heid in place by means of a 5 x 5 cm wide “Micropore” fastening tape. Then the animais trunk is wrapped with a 10 cm wide stretch tape (varicose vein tape) fastened by adhesive tape of the same width, place in such a way so as flot to hinder respiratory movements.
• the rabbits are returned to their cages for 4 hours at the end of which the dressing and the gauze patch are removed. Then, residuai test substance is removed, using absorbent paper moistened with distiiled water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritant / corrosive response data:
- Under the experimental conditions adopted, the application of the substance UG batch 97302300 for 4 hours to the skin of the rabbit, produced, 1 hour after patch removal, the formation of a slight erythema in 1 rabbit and a slight oedema in another one. No cutaneous reactions were seen on the last animal. During the first 72 hours, erythematous and oedematous reactions had disappeared in both of them.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the 67/548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.
- Executive summary:
The application of 0.5 ml of the substance UG batch 97302300 for 4 hours under a semi-occlusive patch to the skin of 3 rabbits, produced, one hour after patch removal, a slight erythema in 1 animal and a slight oedema in another one. The third rabbit did flot exhibit any cutaneous reaction. During the 72 following hours, irritation reactions had totally disappeared.
According to the 671548/EEC order classification, the substance UG batch 97302300 is unclassified among the substances irritating to skin.
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