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Diss Factsheets
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EC number: 407-420-7 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent or similar to EU Method B.4. and OECD Guideline 404 in compliance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): H112323
- Physical state: Dark blue powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK
- Age at study initiation: 15-24 wk
- Weight at study initiation: 3081-4125 g
- Housing: Housed individually in anodised aluminium sheet cages
- Diet (e.g. ad libitum): Labsure CRB Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance pasted with small amount of deion. water
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 30-60 min, 24, 48 and 72 h after removal of the patches, additional readings were performed after 7 d
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Left flank
- % coverage: 2.5 x2.5 cm
- Type of wrap if used: Yes, The treated areas were covered with pieces of surgical gauze (approximate size 2.5 cm x 2.5cm; 8 ply) each of which was secured by two crossed strips of surgical tape (approximate size 1cm x 8cm). These were covered by a piece of impermeable rubber sheeting (approximate size 35cm x 13cm) wrapped once around the trunk of the animal and secured with adhesive impermeable polyethylene tape (7.5cm wide).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently cleansed free of any residual test sample using clean swabs of absorbent cotton wool soaked in clean warm water and were then dried gently with clean tissue paper.
- Time after start of exposure: 4 h
SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the DRAIZE scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no erythema observed
- Remarks on result:
- other: -
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed
- Remarks on result:
- other: -
- Irritant / corrosive response data:
- - There were no signs of erythema in any animal.
- Very slight oedema was seen in two animals 30-60 min after decontamination. There were no additional signs of irritation. - Other effects:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritant to rabbit skin following a single 4-h application.
- Executive summary:
A study was conducted to assess the skin irritation potential of test substance to the rabbit skin equivalent or similar to OECD Guideline 404 and EU Method B.4.
A group of three male rabbits each received a single four-hour application of test sample to the shorn flank. The animals were assessed for any signs of skin irritation 30-60 minutes after decontamination and then daily for 3 days.
Very slight oedema was observed in two animals 30-60 minutes after decontamination. There were no further signs of irritation. In conclusion, Substance H112323 was non-irritant to rabbit skin following a single four-hour application.
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.
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