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EC number: 258-946-7 | CAS number: 54060-92-3
- 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:
- 1989-09-12 to 1989-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- EC Number:
- 258-946-7
- EC Name:
- 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate
- Cas Number:
- 54060-92-3
- Molecular formula:
- C20H24N3O.CH3O4S C21H27N3O5S
- IUPAC Name:
- 2‐{[2‐(4‐methoxyphenyl)‐2‐methylhydrazin‐1‐ylidene]methyl}‐1,3,3‐trimethyl‐3H‐indol‐1‐ium methyl sulfate
- Details on test material:
- - Name of test material: Astrazon Goldgelb GLN trocken
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult rabbits were used
- Weight at study initiation: 2.8 to 3.3 kg
- Housing: individually in stainless steel cages
- Diet: "Ssniff K 4" (Ssniff Spezialdiäten GmbH, Soest), approx 100-120 g per animal and day feeding once per day in the morning
- Water: tap water was available for ad libitum consultion (between 7 and 19 hrs from automatic watering apparatus)
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): ca. 50
- Air changes (per hr): ca 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1989-09-12 to 1989-09-19
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: hypoallergenic Hansamed® - patch (Beiersdorf no. 2342 PV3) covered with semiocclusive dressing (Fixomull® - Stretch Klebevlies, Beiersdorf no. 2293)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- no irritating effects
Any other information on results incl. tables
Table 2: Results of the test for irritant effects on the skin (exposure 4 hours) | |||||||||||
aninmal number | body weight | Draize grade after | |||||||||
1h | 24h | 48h | 72h | 7d | |||||||
e | o | e | o | e | o | e | o | e | o | ||
K35 | 3.3 kg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
K6 | 3.3 kg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
K9 | 2.8 kg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
e: erythema and eschar formation
o: oedema formation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute dermal irritation/corrosion study according to OECD 404 the test substance was found to be non-irritating to the skin.
- Executive summary:
In a primary dermal irritation study (OECD guideline 404), three female New Zealand white rabbits were dermally exposed to 0.5 g of the test item for 4 hours to a body surface area of 6 cm² under semi-occlusive conditions. Animals then were observed for 1, 24, 48, 72 hours and 7 days and irritation was scored by the method of Draize. The test substance did not cause any skin effects and is considered under the conditions of this study as not irritating to the skin.
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