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EC number: 255-785-4 | CAS number: 42373-04-6
- 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:
- 1979-02-15 to 1979-03-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Following a method from "Code Federal Regulations" Title 16, Sections 1500, 41 and 42
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-methyl-2-[(1-methyl-2-phenyl-1H-indol-3-yl)azo]thiazolium chloride
- EC Number:
- 255-785-4
- EC Name:
- 3-methyl-2-[(1-methyl-2-phenyl-1H-indol-3-yl)azo]thiazolium chloride
- Cas Number:
- 42373-04-6
- Molecular formula:
- C19H17N4S.Cl
- IUPAC Name:
- 3-methyl-2-[(1-methyl-2-phenyl-1H-indol-3-yl)azo]thiazolium chloride
- Test material form:
- solid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 – 3.5 kg (males)
- Housing: The rabbits were kept in individual cages measuring 540 x 360 x 315 mm or in restraining devices which allow the back of the animal to be treated.
- Diet (e.g. ad libitum): ad libitum, 200 g of food is provided per animal per day in the form of granules (Granulés Lapin “entretien” SANDERS)
- Water (e.g. ad libitum): ad libitum
Animals were vaccinated against pasteurellosis and myxornatosis.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 20%
- Air changes (per hr): 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, moistend with water (0.4 mL)
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: left flank (intact skin), right flank (scarified skin)
- % coverage: 2 x 2 cm
- Type of wrap if used: The treated areas are covered with a 2 cm square gauze pad consisting of sterile, hydrophilic gauze of four layers. The test material and the gauze pads are kept in contact with the skin by a occlusive patch (Neodermotest Roc) consisting of a central, circular disc of 22 mm diameter with a surrounding adhesive, hypoallergenic, perforated plaster 10 mm wide. Occlusive patches are used to keep the product in contact with the skin since they increase the hydration of the skin and the permeability of the stratum corneum. Finally, an adhesive tape 6 cm is wound around the animal to complete the fixing of patches.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, after 24 hours surplus material which had not penetrated through the skin was removed with a sterile gauze pad soaked in warm water.
OBSERVATION TIME POINTS
1h and 48 hours after patch removal. If after the last reading, any irritation is noted, the animals are maintained under observation for one week. After a total of 7 days, another reading is made.
SCORING SYSTEM:
- Method of calculation: Draize (see Table 1 in box "Any other information on materials & methods incl. tables")
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Max. score:
- 4
- Remarks on result:
- not determinable
- Remarks:
- Erythema could not be assessed as the skin was stained red by the test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation effects were observed on intact skin. Examination of the erythema was mainly impossible within the first 72 h due to the colouration of the skin by the test item. For individual results on intact skin please refer to Table 2 in box "Any other information on results incl. tables".
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this acute dermal irritation/corrosion study, the test item can be considered as non-irritating to the skin.
- Executive summary:
In a primary dermal irritation study, three male New Zealand White rabbits were dermally exposed to 0.5 g of the test item for 24 hours to a body surface area of 2.0 x 2.0 cm under occlusive conditions. Irritation was scored by the method of Draize at 1, 48 hours and 6 days after patch removal. No signs of irritation have been recorded at any of the observation time points. Based on the results, the test item can be considered as not dermally irritating.
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