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EC number: 229-388-1 | CAS number: 6505-28-8
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- EC Number:
- 229-388-1
- EC Name:
- 2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- Cas Number:
- 6505-28-8
- Molecular formula:
- C34H32N6O6
- IUPAC Name:
- 2,2'-[(3,3'-dimethoxybiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(3-oxo-N-phenylbutanamide)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Pigment orange 16 (hereinafter abbreviated as PO16) was used as a test substance. It is also called “Disazo orange” and its name in English is C. I. Pigment Orange 16 having CAS No. 6505-28-8, molecular weight 620.66 and molecular formula C34H32N6O6.
Purity: 99 wt% or higher
The provided test substance contained a water-soluble compound (NaCl) 0.18% as impurity
For this specific material, a particle size characterization is not available.
Constituent 1
- Specific details on test material used for the study:
- - Purity: 99 wt% or higher (impurity: NaCl 0.18 %)
- Name of test material (as cited in study report): Pigment orange 16 (C.I. Pigment Orange 16), Disazo orange
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley [Crj:CD (SD) IGS, SPF]
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Tsukuba Breeding Center, Charles River Laboratories Japan, Inc.)
- Age at study initiation: Four week
- Weight at study initiation: Males: 160 g- 187.5 g (mean: 176.6 g); Females: 135.5 - 164.4 g (mean: 149.7 g)
- Housing: Through the whole breeding period, the animals were housed and bred individually in metal cages with wire-mesh floor (220 w x 270 d x 190 h mm)
- Diet: Solid feed (CE-2, Clea Japan, Inc.), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature: 24 +/- 1 °C
- Humidity: 50 - 65 %
- Air changes: 15 times of ventilation/hour
- Photoperiod: 12-hour light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Dosing volume: 10 mL/kg
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Control group and 100 mg/kg dosing group: 10 animal per sex
Other groups: 5 animals per sex - Control animals:
- yes, concurrent vehicle
- Details on study design:
- recovery period of 14 days
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: The body weight was measured on day 1 immediately before dosing and on day 5 of week 1 of administration period, and at a frequency of twice a week from week 2 of administration period onward during the administration period and the recovery test period. In addition, the body weight was also measured on the day of end of administration period, on the day of end of recovery test period and on the necropsy day
URINALYSIS: Yes
- Time schedule for collection of urine: Urine was collected 4 hours after dosing or fresh urine
- Parameters examined: Color tone, turbidity, pH, occult blood, protein, sugar, and ketone body, Urobilinogen and bilirubin
HAEMATOLOGY: Yes
- Time schedule for collection of blood: End of the test
- Animals fasted: Yes, 18 – 24 hours before blood collection (before autopsy).
- How many animals: All the animals which were autopsied at the end of administration period or at the end of recovery test period
- Parameters examined: Red blood cell count (RBC), White blood cell count (WBC), Hemoglobin content (Hb), Mean corpuscular volume (MCV), Platelet count, Hematocrit (Ht), Mean corpuscular hemoglobin(MCH), Mean corpuscular hemoglobin concentration (MCHC), Differential white blood count, Reticulocyte count, Prothrombin time (PT), Activated partial thromboplastin time (APTT). - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weights determined:
brain, heart, liver, kidneys, thymus, spleen, adrenals, testes, epididymis, ovaries
HISTOPATHOLOGY: Yes
Organ tissues fixed/preserved were
brain, hypophysis, spinal cord, eye ball, thyroid gland, parathyroid gland, heart*, trachea, bronchus, lungs, liver*, kidneys*, thymus, spleen*, adrenal*, stomach, duodenum, jejunum, ileum, cecum, colon, rectum, testis*, epididymis*, prostate, seminal vesicle, ovary*, uterus, vagina, mammary gland, urinary bladder, mandibular lymph node, mesenteric lymph node, skeletal muscle (leg region), sciatic nerve, femur bone marrow, pancreas, submaxillary gland, sublingual gland, tongue, esophagus, aorta, Harderian gland, skin, and gross lesion. - Statistics:
- For body weight, food consumption, hematological and blood biochemical values and the respective measured values of organ weights, the average value and standard deviation were obtained for each group.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- FOOD CONSUMPTION: For females in the 100 mg/kg dosing group, food consumptions at week 4 of administration significantly decreased compared with the control group. In this regard, it is assumed that one animal of the said group showed decreased food consumption due to the false dosing in the same period.
HAEMATOLOGY: For the result of hematological examination at the end of administration period, no significant differences in every examination item were found between the control group and the test substance dosing groups. On the other hand, females in the test substance dosing groups showed an increase in red blood cell count at the end of the recovery test period.
BIOCHEMISTRY FINDINGS
For the examination at the end of administration period, a significantly decreased value of A/G ratio was found in males of the 300 mg/kg dosing group, and a significantly decreased value of potassium concentration was found in females of the 1000 mg/kg dosing group. For the examination at the end of the recovery test period, a significantly decreased value of total cholesterol was found in females of the test substance dosing groups, but there were no significant differences in other test items between the control group and the test substance dosing groups.
GROSS PATHOLOGY
The relative weights of ovaries in the 100 mg/kg dosing group autopsied at the end of administration period showed a significant increase. Except for said case, no significant differences were found in other items including the organ weights of the cases autopsied at the end of administration period.
HISTOPATHOLOGY: For the control group and the 1000 mg/kg dosing group autopsied at the end of administration period, the findings were seen in the lever, kidneys and spleen of both males and females and in the heart of males. However, any differences in the occurrence frequency and extent of the findings were not found among the groups. Furthermore, in 1 female of the control group in which alopecia was macroscopically seen was also found crust as a corresponding change and accessory spleen as well. In 1 female of the 300 mg/kg dosing group were no changes seen except for slight extramedullary hematopoiesis and deposit of brown pigment.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were observed at the limit dose.
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were observed upon subacute gavage dosing of rats at doses of up to 1000 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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