Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 944-439-4 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- march 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The test was conducted by means of Read Across approach. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Royal Decree 363/1995 of March 10
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Brown 188:2 - Similar Substance 01
- IUPAC Name:
- Acid Brown 188:2 - Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: authorized supplier.
- Weight at study initiation:1975-2076 g
- Housing:Housing: Stainless steel single cage
- Diet: daily dose of 150 g experimental diet for rabbits, provided by an authorized vendor
- Water: filtered tap water (5 µm) , ad libitum
- Acclimation period:7 days
- Health check: during observation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21± 2°C
- Humidity (%):55 ± 25%
- Air changes (per hr):15 air change per hour with filtered air (with 5 µm filter)
- Photoperiod : 12 hour cycle dark/light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied:0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1,24,48,72 hours and 7, 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:dorsal-column area near the spine, forming a rectangle 20 cm x 13 cm .
- % coverage: 6 cm^2
- Type of wrap if used: simple bandage and covered in turn with a light hypoallergenic adhesive bandage .
REMOVAL OF TEST SUBSTANCE
- Washing : yes
SCORING SYSTEM:erithema and edema (similar to OECD 404)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- Not irritant for skin
- Executive summary:
The substance was tested for skin irritation with 3 New Zealand white rabbits with an occlusive method. After 72 hours of observation no rabbit shows signs of erythema or edema. The substance is classified as non-irritating to the skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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