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EC number: 282-468-8 | CAS number: 84229-70-9
- 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:
- 25 to 28 May 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Federal Register 38, No 187
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- FDA Federal Register 38, No 187, Patch-Test, occusive scarified and intact skin
- GLP compliance:
- no
Test material
- Reference substance name:
- Reactive Blue 203
- IUPAC Name:
- Reactive Blue 203
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: Reactive Blue 203
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.8 to 2.2 kg
- Housing: single
- Diet (ad libitum): ERKA Z-6000
- Water (ad libitum): tap water
- Acclimation period: NA
IN-LIFE DATES: From: 25. May To: 28. May 1982
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded areas
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- 2 x 500 mg moistened with 0.2 mL physiological saline solution (abraded and intact skin)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- The flank skin was shaved at an area of 6 cm x 3 cm. One half of 3 x 3 cm was abraded by means of a scarificator. A gauze pad (2.5x2.5 cm) with 500 mg pasted test substance was applied to each 3x3 cm test area.
TEST SITE
- Area of exposure: 2 x 3 cm x 3 cm
- Type of wrap if used: polyethylene film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24+72 hours
- Score:
- 0.3
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: abraded and shaved skin
- Irritation parameter:
- erythema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 24 to72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- shaved skin
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 24 to 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Time after application | 24 h | 48 h | 72 h | ||||||||||||||||
Animal number | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | 1 | 2 | 3 | 4 | 5 | 6 | |
abraded | erythema | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
edema | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
shaved | erythema | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
edema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
sum | 8 | 1 | 0 | ||||||||||||||||
primary irritation index (24+72) | 0.33 |
Classification Index:
0.0 to 0.5 non irritant
0.6 to 3.0 slightly irritant
3.1 to 5.0 moderately irritant
5.1 to 8.0 severely irritant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not irritating according to Federal Register 38, No 187
no labelling according to EU guideline - Executive summary:
A group of six rabbits was clipped over a wide area on their backs approximately 24 hours prior to application. One side of the animals' backs was abraded at two sites with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. Two intact skin sites were also selected on the other side of the back.
A 0.5 g portion of the experimental material was applied to two abraded and two intact skin sites on the same rabbit. Gauze patches were then placed over the treated areas and an impervious material wrapped snugly around the trunks of the animals to hold the patches in place. The wrapping was removed at the end of the twenty-four hour contact period, the sites wiped but not washed, and the treated areas examined. Readings were also made after 72 hours. The Draize method of scoring was employed. All other lesions observed were recorded. No irritating effects were observed at any reading. The Mean Primary Irritation Score was: 0.3
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