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EC number: 400-720-9 | CAS number: 126851-40-9 SÄUREBRAUN 6229
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Department of Toxicology, BASF AG
- Limit test:
- no
Test material
- Reference substance name:
- Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex
- EC Number:
- 400-720-9
- EC Name:
- Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex
- Cas Number:
- 126851-40-9
- Molecular formula:
- C22H11FeN6NaO10S.H2O
- IUPAC Name:
- λ²-iron(2+) sodium 2-[2-(3,5-dinitro-2-oxidophenyl)diazen-1-yl]-5-hydroxy-4-[2-(6-sulfonatonaphthalen-1-yl)diazen-1-yl]benzen-1-olate hydrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr . Karl Thomae GmbH, Biberach a. d. Riss, FRG
- Age at study initiation: 42 d
- Weight at study initiation: mean 162 g (males), 134 g (females)
- Housing: singly in type DK III stainless steel wire cages, supplied by BECKER & CO., Castrop-Rauxel, FRG (floor area about 900 cm2)
- Diet (e.g. ad libitum): was ground Kliba rat/mouse "A" maintenance diet, GLP 343 meal, supplied by Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Drinking water solutions were prepared twice a week by weighing the test substance and then disolving it in-drinking water using a magnetic stirrer. The stability of the drinking water solutions was confirmed over a period of 5 days. The concentration of the drinking water solutions was verified on the basis of one sample of each concentration, taken at the start of the study, in a double determination. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The content of Säurebraun 6229 in the drinking water was determined by the UV-VIS method.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- continously by drinking water
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 5000, 10000 ppm
Basis:
nominal in water
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked in table.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at each weighing, thus once a week
BODY WEIGHT: Yes
- Time schedule for examinations: All the animals were weighed once a week. The body weight was always determined on the same day of the week and at the same time of the day
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: determined twice a week
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 9 days (female animals, 10000 ppm ) or 25 days after the beginning of administration (blood sampling 1)
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: all
- Parameters examined: hemoglobin, erythrocytes, hematocrit, mean hemoglobin content per erythrocyte, mean corpuscular volume, mean corpuscular hemoglobin concentration, platelets, leukocytes, differential blood count, prothrombin time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 9 days (female animals, 10000 ppm ) or 25 days after the beginning of administration (blood sampling 1)
- Animals fasted: no
- How many animals: all
- Parameters examined: total bilirubin, creatinine, urea, sodium, potassium, total protein, glucose, inorganic phosphate, calcium, chloride, triglycerides, cholesterol albumin, glutamic-pyruvic transaminase, alkaline phosphatase, glutamic-oxalacetic transaminase
URINALYSIS: Yes
- Time schedule for collection of urine: 29 days after the beginning of treatment
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: pH, protein, glucose, ketones, bilirubin, blood, nitrite, urobilinogen, sediment
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes: liver, kidneys, spleen, adrenals, heart, testes, gastrointestinal tract and all gross lesions - Statistics:
- - ANOVA followed by DUNNETT's test: body weights
- WILLIAMS test: absolute organ weights
- t- test: blood and plasma examinations
- chi-square test in corresponding two by two contingency tables: urinalysis
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- brown feces from day 1 for all concentrations and yellow urine from day 10;
- one female showed a yellowish brown smear in the anogenital region, and this started with day 7 after the beginning of the administration period - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 10000 ppm:
- 2/5 animals died 14 days after the beginning of the administration period.
- 1 female animal was sacrificed in a moribund state on day 18 after the beginning of the study; due to their poor state of health, remainin g females were sacrificed prematurely on day 9 after the beginning of the administration period - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 10000 ppm:
- pronounced reduction in body weight in 3/5 females and reduction in body weight throughout the study in males
5000 ppm:
- reduction in body weight in the male and female animals throughout the study - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- 10000 ppm:
- severe reduction in feed consumption in 3/5 females
- in males, reduction in feed consumption in the 1st week of the study followed by an increase to above the control values
5000 ppm:
- reduced feed consumption in the female animals in the 1st to 3rd week of the study and in the male animals in the first half of the study - Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- 10000 ppm:
- extreme reduction in water consumption in 4/5 females
- reduced water consumption in 3/5 males in the 1st week of the study followed by an increase in water consumption to above the control values
5000 ppm:
- reduced drinking water consumption in 3 of 5 male and female animals, approaching or exceeding the control values during the study - Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 10000 ppm:
- in females increase in the following values: prothrombin time, hemoglobin, erythrocyte count, hematocrit, mean corpuscular volume (MC V), polymorphonuclear neutrophils and atypical lymphocytes as well as polychromasia. Decrease in mean hemoglobin content per erythro cyte (MCH), mean corpuscular hemoglobin concentration (MCHC) and platelet count
- in males increase in the polymorphonuclear neutrophil count and increased incidence of polychromasia and anisocytosis
5000 ppm
- reduction in glucose and hemoglobin values in the male animals
- increase in polymorphonuclear neutrophils and monocytes in both sexes and increase in the cholesterol and leukocyte, lymphocyte and platelet counts in the male animals
- increased polychromasia in the male and female rats and increased anisocytosis in the male animals - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 10000 ppm:
- In females increase in the following values: urea, sodium, inorganic phosphate, chloride, glutamic pyruvic transaminase, glutamic oxalac etic transaminase. Decrease in total protein and albumin
- In males increased urea levels
5000 ppm:
- reduction in total protein and albumin concentrations in both sexes - Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 5000 ppm:
- increase in the inorganic phosphate concentration and urea levels and increased excretion of renal epithelial cells in the female animals - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 10000 ppm:
- Necrotizing typhlitis and edemas in the cecum in males and females
5000 ppm.
- necrotizing typhlitis and edemas of the cecum in the male and female animals
- necrotizing colitis in the male rats - Details on results:
- CLINICAL SIGNS AND MORTALITY
10000 ppm:
- 2/5 animals died 14 days after the beginning of the administration period.
- 1 female animal was sacrificed in a moribund state on day 18 after the beginning of the study; due to their poor state of health, remainin g females were sacrificed prematurely on day 9 after the beginning of the administration period
- a blackish brown colored feces from day 1 on; yellowish brown colored urine from day 10 on
5000 ppm:
- blackish brown colored feces in males and females from day 1 on
- addition showed yellowish brown colored urine from day 10 on
- one female showed a yellowish brown smear in the anogenital region, and this started with day 7 after the beginning of the administratio n period
500 ppm:
- blackish brown colored feces in males and females
- addition showed yellowish brown colored urine from day 10 on
BODY WEIGHT AND WEIGHT GAIN
10000 ppm:
- pronounced reduction in body weight in 3/5 females and reduction in body weight throughout the study in males
5000 ppm:
- reduction in body weight in the male and female animals throughout the study
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
10000 ppm:
- severe reduction in feed consumption in 3/5 females
- in males, reduction in feed consumption in the 1st week of the study followed by an increase to above the control values
5000 ppm:
- reduced feed consumption in the female animals in the 1st to 3rd week of the study and in the male animals in the first half of the study
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
10000 ppm:
- extreme reduction in water consumption in 4/5 females
- reduced water consumption in 3/5 males in the 1st week of the study followed by an increase in water consumption to above the control values
5000 ppm:
- reduced drinking water consumption in 3 of 5 male and female animals, approaching or exceeding the control values during the study
HAEMATOLOGY
10000 ppm:
- in females increase in the following values: prothrombin time, hemoglobin, erythrocyte count, hematocrit, mean corpuscular volume (MC V), polymorphonuclear neutrophils and atypical lymphocytes as well as polychromasia. Decrease in mean hemoglobin content per erythro cyte (MCH), mean corpuscular hemoglobin concentration (MCHC) and platelet count
- in males increase in the polymorphonuclear neutrophil count and increased incidence of polychromasia and anisocytosis
5000 ppm
- reduction in glucose and hemoglobin values in the male animals
- increase in polymorphonuclear neutrophils and monocytes in both sexes and increase in the cholesterol and leukocyte, lymphocyte and platelet counts in the male animals
- increased polychromasia in the male and female rats and increased anisocytosis in the male animals
CLINICAL CHEMISTRY
10000 ppm:
- In females increase in the following values: urea, sodium, inorganic phosphate, chloride, glutamic pyruvic transaminase, glutamic oxalac etic transaminase. Decrease in total protein and albumin
- In males increased urea levels
5000 ppm:
- reduction in total protein and albumin concentrations in both sexes
URINALYSIS
5000 ppm:
- increase in the inorganic phosphate concentration and urea levels and increased excretion of renal epithelial cells in the female animals
GROSS PATHOLOGY
10000 ppm:
- Necrotizing typhlitis and edemas in the cecum in males and females
5000 ppm.
- necrotizing typhlitis and edemas of the cecum in the male and female animals
- necrotizing colitis in the male rats
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 55 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- haematology
- Dose descriptor:
- NOAEL
- Effect level:
- > 55 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- clinical biochemistry
- haematology
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Based on additional testing , the authors concluded that the increase in bilirubin detected in the urine is due to an interfering reaction of
the test substance with the test method used. Therefore, the increased bilirubin levels in the urine are not regarded as having any pathognostic relevance.
Substance intake (mg/kg bw/d):
Dose group | Sex | Days | |||
1 - 7 | 8 - 14 | 15 - 21 | 22 - 28 | ||
500 ppm | male | 63 | 54 | 46 | 45 |
female | 73 | 57 | 53 | 47 | |
5000 ppm | male | 536 | 636 | 728 | 736 |
female | 489 | 635 | 732 | 665 | |
10000 ppm | male | 897 | 1984 | 1670 | 1465 |
female | 772 | x | x | x |
Body weights (g):
Dose group | Sex | Day | ||||
0 | 7 | 14 | 21 | 28 | ||
control | male | 161.0 ± 6.6 | 211.3 ± 12.6 | 249.6 ± 15.1 | 277.6 ± 14.0 | 296.8 ± 15.2 |
female | 133.5 ± 4.4 | 160.6 ± 7.1 | 182.7 ± 5.8 | 195.8 ± 10.6 | 209.4 ± 15.1 | |
500 ppm | male | 162.0 ± 6.6 | 212.3 ± 11.9 | 252.1 ± 18.0 | 283.7 ± 17.9 | 312.3 ± 19.9 |
female | 133.9 ± 4.8 | 162.6 ± 6.6 | 186.0 ± 10.8 | 203.4 ± 11.7 | 210.4 ± 12.9 | |
5000 ppm | male | 160.3 ± 5.3 | 169.7 ± 15.6* | 184.3 ± 26.9** | 212.7 ± 19.2** | 235.8 ± 20.6** |
female | 133.3 ± 3.6 | 130.5 ± 23.1 | 143.4 ± 34.9* | 175.0 ± 13.2* | 185.9 ± 12.1* | |
10000 ppm | male | 161.0 ± 5.2 | 146.8 ± 39.2** | 209.1 ± 15.3** | 244.8 ± 9.9* | 273.9 ± 5.7 |
female | 133.5 ± 4.0 | 107.3 ± 33.2** | x | x | x | |
Different from control: *p<0.05; **p<0.01 (Anova + Dunett's, two sided) |
Applicant's summary and conclusion
- Conclusions:
- The substance was tested for repeated dose toxicity oral in rats following OECD 407-. Under the experimental conditions the NOAEL resulted > 55 mg/kg bw/ day (mena value) for males and females.
- Executive summary:
The substance was tested for repeated dose toxicity oral in rats following OECD 407 . Ten wistar rats for each group were exposed to the substance by oral, dissolving the substance in the drinking water at the following concentrations 500, 5000 and 10000 ppm, corresponding ca to 55, 645 or 1358 mg/kg bw/day (mean uptake of test substance by male (m) and female (f) animals)
. Mortality was observed at the highest dose. Clinical signs as coloured feces and urine at all doses. Biochemisry and hematological findings were recorded at 5000 and 10000 ppm as well as urinalysis. Under the experimental conditions the NOAEL resulted > 55 mg/kg bw/ day (mena value) for males and females.
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