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Diss Factsheets
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Reaction mass of 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(3-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s) and 6-(2-ethyl-6-methylanilino)-5-(4-{4-[ethyl(4-sulfobenzyl) amino] phenylazo} phenylazo)-4-hydroxynaphthalene-2-sulfonic acid, sodium and/or disodium salt(s)
EC number: 475-080-7 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1995
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Acid Navy RN-2682
- IUPAC Name:
- Acid Navy RN-2682
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanRcc
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Clinical signs, outside cage observation, food consumption and body weights were recorded periodically during the acclimaitization and treatment periods. Functional observational battery, locomotor activity and grip strength were performed during week 4.
At the end of the dosing period, blood samples were withdrawn for hematology and plasma chemistry analyses. All animals were killed, necropsied and examined post mortem. Histological examinations were performed on organs and tissues from all control and high dose animals, and all gross lesions from all animals.
From the animals of the low and middle dose groups, the liver (males only), lung, spleen, and the bone marrow (femur) were examined to establish a no-effect level.
Results and discussion
Results of examinations
- Description (incidence and severity):
- No test item-related signs of adverse toxicity were noted at any dose level during daily observations and no test item-related changes of adverse toxicity were noted during weekly behavioral observations (weeks 1-3).
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- A trend toward lower production and increased turnover of red blood cells was noted in males treated with 1000 mg/kg/day, although nearly all values remained within the range of the historical control values.
Females at 1000 mg/kg/day and both sexes treated with 250 mg/kg/day or 50 mg/kg/day were unaffected. - Description (incidence and severity):
- At 1000 mg/kg/day, slightly elevated lactate dehydrogenase levels were noted in males and females. The differences noted did not attain statistical significance and were considered to be the result of the mild increase in red blood cell turnover described above.
- Description (incidence and severity):
- Functional observational battery
No test item-related changes were noted during functional observation battery (week 4).
Grip strength
The mean fore- and hind limb grip strength values of the test item-treated rats compared favorably with those of the controls.
Locomotor activity
Minor differences between the mean locomotor activity of the test item-treated rats and control rats were considered to be within the range of typical background variation. - Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Minor differences in some mean absolute and relative organ weights were not supported by microscopical changes and were therefore considered to be incidental.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A small number of test item-unrelated background findings were noted. None of the observed findings were considered to be of toxicological relevance.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Microscopic findings considered to be test item-related were recorded in following organs:
• liver: minimal hepatocellular hypertrophy in two male animals treated with 1000 mg/kg/day. The hepatocellular hypertrophy was considered to be of adaptive character.
• lung: increased mean severity grade of alveolar macrophages in animals treated with 250 mg/kg/day and 1000 mg/kg/day, and increased incidence of alveolar macrophages in animals treated with 1000 mg/kg/day. Further minimal brownish pigment in animals treated with 1000 mg/kg/day. These findings were deemed to be due to accidental aspiration.
• spleen: increased mean severity grade of erythropoiesis in animals treated with 50, 250 and 1000 mg/kg/day. Additional increased mean severity grade of hemosiderin in male animals treated with 250 and 1000 mg/kg/day, and in female animals at all dose levels.
• bone marrow (femur): increased erythropoiesis in two animals treated with 1000 mg/kg/day. - Details on results:
- Test item-related findings were generally restricted to the highest dose level of 1000 mg/kg/day, in which a mild reduction in red cell production and increased red cell turnover were noted, with a concomitant elevation in lactate dehydrogenase levels. Test item-related microscopical changes included minimal hepatocellular hypertrophy in the livers of two males treated with 1000 mg/kg/day (considered to be an adaptive change).
Increased erythropoiesis in the spleens of animals treated with 50, 250 and 1000 mg/kg/day, and the bone marrow of one male treated with 1000 mg/kg/day was considered to be test item-related and adaptive to the changes in red cell production described above. Hemosiderin deposition in the spleens of male animals treated with 250 and 1000 mg/kg/day, and in female animals at all dose levels was also considered to result from the described changes in red cell production.
Increased mean severity grade of alveolar macrophages in the lungs of animals treated with 250 mg/kg/day and 1000 mg/kg/day, and increased incidence of alveolar macrophages in animals treated with 1000 mg/kg/day. Further minimal brownish pigment was noted in animals treated with 1000 mg/kg/day. These findings were deemed to be due to accidental aspiration, rather than to systemic toxicity.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 1000 mg/kg bw/day
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