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Diss Factsheets
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EC number: - | 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 / corrosion, other
- Remarks:
- An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo study are available.
- Type of information:
- other: read across from supporting substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
- GLP compliance:
- no
- Remarks:
- Study conducted before 1981
Test material
- Reference substance name:
- Acid Blue 158
- IUPAC Name:
- Acid Blue 158
Constituent 1
In vitro test system
- Control samples:
- yes, concurrent no treatment
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Porton
- Age at study initiation: 9-15 weeks
- Weight at study initiation: 2.44 Kg (♂), 2.10 kg (♀)
- Housing: Bred oh the premises and maintained under a semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad lib.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08:00 - 18.00 hours.
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml, 0.75 ml of which was applied to each test site - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- Six rabbits (5 ♂ and 1 ♀)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 10 % of the total body surface.
- Type of wrap if used: The site were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.
SCORING SYSTEM: Draize et al.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 11, 12, 13, 14, 15
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 16
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 11, 12
- Time point:
- other: Mean score after 24 ,48 and 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 14, 16
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction observed
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- other: mean score after 24, 48 and 72 hours
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- animal: 15
- Time point:
- other: Mean score after 24, 48 and 72 hours
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: shaved skin
- Irritant / corrosive response data:
- The value assessed at 24 hours was used also for 48 hours in a protective manner because no observation was made at 48 hours after the beginning of test.
Any other information on results incl. tables
Slight erythema and very slight to moderate oedeme was seen in 2/6 and 6/6 rabbits respectively, 24 hours after application of the compound. Very slight oedema was still present on 1/6 abraded sites at 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- The substance is not irritating for skin rabbit.
- Executive summary:
The substance has been tested for skin irritation according to the method "Hazardous Substances Regulations" under the U.S. federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). During the test 5 male and 1 female rabbits are tested with 10 g of test item on shaved and abraded skin after 24 hours of patch treatment. Under the conditions of the present experiment the substance was considered to be not irritant for rabbit skin.
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