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Diss Factsheets
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EC number: 434-230-1 | CAS number: 144413-22-9
- 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:
- 30 July 1998 - 07 August 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): ARAKAWA KE-604
- Physical state: pale yellow blocks
- Analytical purity: no data
- Lot/batch No.: R61132
- Storage condition of test material: room temperature in the dark.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.75 - 2.80 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): mains drinking water
- Water (e.g. ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 65-74
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12
EXPERIMENTAL DATES: The study was performed between 30 July 1998 and 07 August 1998
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping using a veterinary clipper
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL of distilled water
- Duration of treatment / exposure:
- Initially treated rabbit: 3 minutes, 1 hour and 4 hours.
2nd and 3rd rabbit: 4 hours. - Observation period:
- 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal flank area
- % coverage: 6.25 cm2
- Type of wrap if used:
The cotton gauze patch was held in position with a strip of surgical adhesive tape (BLENDERM).
The trunk of the animal was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 minutes, 1 h, 4 h.
SCORING SYSTEM: According to Draize J H, 1977, "Dermal and Eye Toxicity Tests" in : Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p. 31.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean of
- Time point:
- other: 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean of
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No other effects noted.
Any other information on results incl. tables
Table 1: Individual skin examination scores after 4h-exposure
Skin effect |
Erythema |
Edema |
||||||||
Scoring [h]a |
1 |
24 |
48 |
72 |
Meanb |
1 |
24 |
48 |
72 |
Meanb |
Animal No. /sex #1 / m |
1 |
0 |
0 |
0 |
0.0 |
1 |
0 |
0 |
0 |
0.0 |
#2 / m |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
#3 / m |
1 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
aTimepoint of reading after substance removal subsequent to 4h-dermal exposure
bMean of 24, 48 and 72 h scores
Summary:
In a primary dermal irritation study, the skin irritation/corrosion potential of ARAKAWA KE-604 was tested. The clipped dorsal flank area of 3 male New Zealand White rabbits was exposed for 4 hours to 0.5 g of the test substance moistened with 0.5 mL of distilled water under semi-occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed according to Draize scheme 1, 24, 48 and 72 hours after removal of the test substance. No oedema and no erythema was noted at the 24, 48 and 72 hour observation intervals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information No classification is needed according to EU classification criteria. Criteria used for interpretation of results: EU
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