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EC number: 419-720-5 | CAS number: 182061-89-8
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 December 1995 to 21 December 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, performed to valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 419-720-5
- EC Name:
- -
- Cas Number:
- 182061-89-8
- Molecular formula:
- C25H26N9O12S3 . 3 Na
- IUPAC Name:
- trisodium 6-amino-5-{2-[4-({4-[bis(2-hydroxyethyl)amino]-6-[(2-sulfonatoethyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazen-1-yl}-4-hydroxynaphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): M-377
- Physical state: solid
- Appearance: garnet powder
- Storage condition of test material: room temperature and protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Sprague-Dawley ICO: OFA-SD (IOPS Caw)
- Age at study initiation: approximately 8 weeks
- Weight at study initiation (mean ± standard deviation): 287 ± 4 g (males); 230 ± 5 g (females)
- Housing: Animals of the same sex caged in groups of 4 - 7 in polycarbonate cages (48 cm x 27 cm x 20 cm) during acclimatisation; animals were caged individually (35.5 cm x 23.5 cm x 19.3 cm) during treatment period.
- Diet: pelleted diet, ad libitum
- Water: Filtered drinking water (0.22 µm), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From 7 December 1995 to 21 December 1995
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
On the day before treatment, the dorsal area (6 cm x 8 cm) of each animal was clipped free of fur. A single dose of 2000 mg/kg of the test material, moistened with 2 mL water, was applied to the test site on a hydrophilic gauze pad. The gauze covered an area representing approximately 10 % of the body surface area of the animals. The gauze pad was held in place by means of an adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage.
REMOVAL OF TEST SUBSTANCE
Any residual test material was removed with a moistened (distilled water) gauze pad. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
The volume applied to each animal was adjusted according to body weight determined on the day of treatment. - No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: animals were observed frequently during the hours following administration of the test material and at least once daily thereafter.
- Frequency of weighing: animals were weighed individually just before administration of the test material on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen, and any other organs with obvious abnormalities) was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- other: No clinical signs and no cutaneous reactions were observed during the study. Very slight to moderate red colouration of the test site was noted in all animals up to day 5.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, none of the animals died and no clinical signs were recorded. The LD50 of the test material was subsequently determined to be in excess of 2000 mg/kg bw. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The acute dermal toxicity of the test material was determined in accordance with standardised guidelines OECD 402 and EU Method B.3. Five male and female rats received a single dermal application of 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. None of the animals died and there were no signs of systemic toxicity. Very slight to moderate red colouration of the test site was noted in all animals up to day 5. The body weight gain of the animals was not influenced by treatment. There were no macroscopic abnormalities at examination post mortem. The acute dermal median lethal dose of the test material was subsequently estimated to be in excess of 2000 mg/kg to both male and female rats.
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