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Reaction mass of isomers disodium 8-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-5-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate, disodium 5-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-8-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
EC number: 700-946-0 | CAS number: -
- 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
NOAEL (oral) ≥ 300 mg/kg bw/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
- 300 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
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 test item was tested for subchronic toxicity using the OECD Test Guideline No. 407, Repeated Dose 28-day Oral Toxicity Study in Rodents.
The oral administration of the test substance to rats by gavage for a period of 28 consecutive days did not cause mortality related with the test item treatment.
No effect of the test item on the body weight, food consumption and water consumption were recorded during the study. Slight changes of these parameters were without toxicological importance.
At a daily oral dose of 1000 mg/kg, test item lead to an increased serum concentration of total bilirubin, increased reticulocyte formation and – in female – decreased mean corpuscular hemoglobin concentration. Histopathological evaluation indicated in the spleen, an increase in the incidence and mean severity grade of multifocal extramedullary hemopoiesis in males and females treated at 1000 mg/kg/day. In addition, in females of this dose group, only, the incidence and mean severity grade of multifocal golden-brown pigment (interpreted as hemosiderin) was also increased. There was recovery for the extramedullary hemopoiesis, but not for the occurrence of golden-brown pigment. Moreover, spleen weight was increased at the end of the recovery period. In view of the changes in hematological parameters noted in this study group, an adverse character of the spleen effect cannot be completely discounted.
Furthermore, treatment with test item caused alteration in liver weight in males and female at almost all dose levels associated with minimal or mild centrilobular hepatocellular hypertrophy which was noted in females of all dose groups and one single male at 1000 mg/kg/day.
The liver changes recovered completely during the recovery period. Minimal diffuse follicular cell hypertrophy of the thyroid gland observed at 1000 mg/kg/day is considered to be secondary to the liver change. Liver hypertrophy was interpreted as a minor adaptive change of the liver, probably involving the induction of hepatic microsomal enzymes, and as being non-adverse.
A test item-relationship of a minimal multifocal vacuolation of the inner cortex in the adrenal gland at 1000 mg/kg/day could not be excluded.
Based on these findings, the red blood cell system is considered to be a target system of test item. Based on histopathological findings in the spleen that failed to show complete recovery, the NOAEL for this study was established at 300 mg/kg bw/day.
Justification for classification or non-classification
For the classification of the substance as STOT-RE the dose in which significant toxic effects are observed is taken into consideration. If this dose is in the range of the guidance values indicated in the CLP Regulation (EC) No. 1272/2008 Annex I: 3.9.2.9.6 and Annex I: 3.9.2.9.7 then the substance is classified in Category 1 or Category 2 respectively.
Based on the available repeated dose toxicity studies, the substance is not classified for STOT-RE according to the CLP Regulation (EC) No. 1272/2008.
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