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A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate
EC number: 406-870-1 | CAS number: 115100-55-5
- 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
Endpoint summary
Administrative data
Description of key information
NOEL (oral, 28 d) = 50 mg/kg/day
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- System:
- haematopoietic
- Organ:
- spleen
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The repeated dose toxicity of the substance was evaluated in a subacute 28-day toxicity study, according to the OECD Guideline 407 (1981) and method B.7 of the EEC-Directive 92/69 EEC.
A 5-day range finding study was performed (with 3 rats/sex/group at dose levels of 50, 200 and 1000 mg/kg/day) to provide a basis for selection of dose levels for a study of longer duration.
With the exception of dark appearance of the feces, no differences of biological significance were apparent between animals of the 3 treatment groups.
Based on these observations, a high treatment level of 1000 mg/kg/day was selected for a study of 28 days duration.
In the main study, the test item was administered dally by gavage to SPF-bred Wistar rats. The study comprised of four groups. The number of rats assigned to toxicity testing per group as well as the dose levels administered were as follows:
group | Dose level mg/kg | males | females |
1 | 0 | 1-5 | 21-25 |
2 | 50 | 6-10 | 26-30 |
3 | 200 | 11-15 | 31-35 |
4 | 1000 | 16-20 | 36-40 |
The following findins were observed.
At 50 mg/kg/day: No treatment-related changes detected.
At 200 mg/kg/day:
1) Dark appearance of the faeces was noted in males and females.
2) Microscopically observed accumulatlon of iron pigments were noted in the spleen of males and females.
At 1000 mg/kg/day:
1) Dark appearance of the faeces was noted in males and females
2) Increased total white blood cell counts were noted in males and females,
3) Increased spleen weights and relative spleen weights were noted in males and females and increased relative kidney weights were noted in males only.
3) Microscopically observed accumulatlon of iron pigments and increased number of haemopoletic foci were noted in the spleen of males and females.
From the results presented in this report a definitive no observed effect level (NOEL) of 50 mg/kg/day was established.
Justification for classification or non-classification
According to the CLP Regulation (EC) no. 1272/2008, classification in Category 1 for repeated dose toxicity applies to substances that have produced significant toxicity in humans or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following repeated exposure. Substances are classified in Category 1 for target organ toxicity (repeat exposure) on the basis of:
— reliable and good quality evidence from human cases or epidemiological studies; or
— observations from appropriate studies in experimental animals in which significant and/or severe toxic effects, of relevance to human health, were produced at generally low exposure concentrations.
Classification in Category 2 applies to substances that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to be harmful to human health following repeated exposure. Substances are classified in Category 2 for target organ toxicity (repeat exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. If classification is based on results obtained from studies conducted in experimental animals, the dose/concentration guidance values that classify refer to effects seen in a standard 90-day toxicity study conducted in rats. These guidance values are presented in the CLP Regulation (EC) no. 1272/2008) in Annex 1: 3.9.2.9.6., Table 3.9.2 for classification in Category 1 and in Annex 3.9.2.9.7., Table 3.9.3 for classification in Category 2. For a 28-day study the guidance values is increased by a factor of three.
As the only effects observed at 200 mg/kg/day in the Repeated Dose 28-Day Oral Toxicity Study were dark faeces and iron pigments in the spleen, and as these may not be considered adverse effects of systemic toxic relevance, 200 mg/kg/day can be extrapolated to be the LOEL value of the substance. Therefore, the NOAEL is expected to be greater than this value, and at 300 mg/kg/day the eventual effects are expected to be more comparable to those at 200 than 1000 mg/kg/day. Therefore, no classification for repeated dose toxicity is warranted under the CLP Regulation (EC) no. 1272/2008.
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