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EC number: 421-950-6 | CAS number: 187674-70-0 Y-104
- 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:
- 21 June 1995 to 24 June 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate
- EC Number:
- 421-950-6
- EC Name:
- Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate
- Cas Number:
- 187674-70-0
- Molecular formula:
- C27H26N6Na4O13S6
- IUPAC Name:
- tetrasodium 3-{2-[4-({4,6-bis[(3-sulfonatopropyl)sulfanyl]-1,3,5-triazin-2-yl}amino)-5-methoxy-2-methylphenyl]diazen-1-yl}naphthalene-1,5-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Substance type: yellow-brown to orange powder.
- Storage condition of test material: at room temperature.
- pH: measured at the test facility at a concentration of 10% (w/w) in distilled water was 6.6.
Constituent 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: 2.7 ± 0.1 kg
- Housing: Individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm).
- Diet: Pelleted diet ad libitum.
- Water: Filtered water ad libitum
- Acclimation period: At least 5 days.
- Animal selection: The day before treatment, the skin of ach animal was examined in order to use only animals without any signs of cutaneous irritation. Animals showing signs of cutaneous irritation, cutaneous defects or pre-existing dermal injury were not used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 – 70 %
- Photoperiod: 12 hour light/dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg per animal as supplied. - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 72 hours.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on the right flank of each animal. The left flank (clipped) served as an untreated control.
- Type of wrap if used: The test material was prepared on a gauze pad moistened with 0.5 mL of distilled water, and held in place with an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test material was removed with gauze moistened with water.
- Time after start of exposure: 4 hours.
SCORING SYSTEM:
Cutaneous examinations were performed at approximately 1, 24, 48 and 72 hours after the removal of the dressing. Dermal irritation was evaluated in accordance with the Draize scale, see Table 1. Any other lesions were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Mean of observations at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Mean of observations at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Mean of observations at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean of observations at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean of observations at 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Mean of observations at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight orange colouration of the test site which could not mask an erythema was observed on all animals during the study.
No skin reaction was noted in one animal.
A very slight or slight erythema (grade 1 or 2) was observed one hour after treatment in two of the animals. Erythema persisted for 24 hours in one rabbit only.
No oedema was noted at any time.
Any other information on results incl. tables
Table 2: Individual Dermal Reactions
Rabbit No. |
Dermal Irritation |
Scores |
Mean Irritation Score |
|||
1 hr |
24 hrs |
48 hrs |
72 hrs |
|||
01 |
Erythema |
1 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
C |
C |
C |
* |
|
|
02 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
C |
C |
C |
* |
|
|
03 |
Erythema |
2 |
1 |
0 |
0 |
0.3 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
C |
C |
C |
C |
|
Mean score calculated from readings taken at 24, 48 and 72 hours.
* = None
C = Orange colouration of the skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material is considered to be a non-irritant since none of the animals displayed a classifiable reaction.
- Executive summary:
The acute dermal irritation of the test material was determined in vivo in a study conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU method B.4.
Three male New Zealand White rabbits were exposed to 500 mg of the test material for 4 hours. Dermal irritation was assessed 1 hour after removal and then at 24, 48 and 72 hours after removal according to the Draize scale. Any other lesions were noted.
A very slight orange colouration of the test site which could not mask an erythema was observed on all animals during the study. No skin reaction was noted in one animal. A very slight or slight erythema (grade 1 or 2) was observed one hour after treatment in two of the animals. Erythema persisted for 24 hours in one rabbit only. No oedema was noted at any time.
Under the conditions of the test, the test material is considered to be a non-irritant since none of the animals displayed a reaction severe enough to trigger classification.
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