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EC number: 228-771-0 | CAS number: 6358-37-8
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From JAN 1974 to APR 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, comparable to standards
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- publication
- Title:
- Carcinogenicity studies on different diarylide yellow pigments in mice and rats
- Author:
- Leuschner F
- Year:
- 1 978
- Bibliographic source:
- Toxicology Letters 2: 253-260
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- EC Number:
- 228-787-8
- EC Name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]
- Cas Number:
- 6358-85-6
- IUPAC Name:
- 2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(3-oxo-N-phenylbutanamide)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S. IVANOVAS GmbH & Co, Med. Versuchstierzucht KG (Kissleg, Germany)
- Age at study initiation: 26 (males) -27 (females) days
- Weight at study initiation: 18.1 - 20.1 g
- Housing: individually in Macrolon cages (Type I)
- Diet: Altromin 1321 (Altromin, Lage), ad libitum
- Water: tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 0.5
- Humidity (%): 60 +/- 3
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- daily
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000, 3000, 9000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
- Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice per day
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
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: Yes
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 data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: daily
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: once, immediately before sacrifice
- Dose groups that were examined: all animals
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER:
at the end of the exposure period the following investigations were performed:
- audiometry (simple sound test)
- inspection of denture
- organ weights from 7-8 organs (heart, liver, lungs, spleen, kidney, thymus, brain, testis) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (animals of the control and highest dose group; paraffin sections, Haematoxylin-Eosin staining):
heart, lung, liver (additionally: frozen sections with Sudan stainings), kidney, spleen, adrenal, thymus, pituitary, brain, gonads, thyroid, prostate, uterus, seminal vesicle, mammary gland, stomach, duodenum, colon, salivary gland, lymph nodes, eye and optic nerve, urinary bladder, bone marrow, neoplastic lesions, bones
- histopathological investigations of animals of the lower dose groups were performed, if they died or were sacrificed in the meantime and revealed macroscopic findings - Statistics:
- - variance analysis according to Peto
- Student's t-test
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):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Relevance of carcinogenic effects / potential:
- The study design is in accordance with existing guidelines. Therefore, the results are considered relevant for the evaluation of the carcinogenic potential of the test item.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 9 000 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no increased tumour incidence in treated animals in comparison to controls, 9000 ppm in diet correspond to 1957.1 mg/kg bw/da and 2030.6 mg/kg bw/day in male and female mice, respectively (calculated in the study report on basis of food consumption)
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Any other information on results incl. tables
- no substance induced macroscopic or histological changes
- no substance related effects on the tumour incidence (overall tumour rate: 42%, 45%, 40%, 46% in the control, 1000 ppm, 3000 ppm and 9000 ppm dose group, respectively; males: 30%, 36%, 24%, 40%, females: 54%, 54%, 56%, 52% in the control, 1000 ppm, 3000 ppm and 9000 ppm dose group, respectively) - 1000, 3000, 9000 ppm test item in diet correspond to 214, 649, 1957 mg/kg bw/day in male and 219, 681, 2031 mg/kg bw/day in female mice, respectively
Applicant's summary and conclusion
- Conclusions:
- Chronic feeding of NMRI mice with up to 9000 ppm test item in diet (corresponding to 1957 and 2030 mg/kg bw/day in male and female mice, respectively) did not result in an increased tumour incidence in comparison to the control animals, indicating that the test item is not carcinogenic.
- Executive summary:
NMRI mice (50 per sex per dose) were exposed to 1000, 3000, 9000 ppm test item in feed (corresponding to 214, 649, 1957 mg/kg bw/da and 219, 681, 2030 mg/kg bw/day in male and female mice, respectively) for 104 weeks. The test item did not induce a treatment related increase in toxicity or tumour incidences. The results of this study do not provide evidence for carcinogenicity of the test item in NMRI mice.
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