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EC number: 225-822-9 | CAS number: 5102-83-0
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- year of publication: 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Lack of bioavailability of dichlorobenzidine from diarylide azo pigments: molecular dosimetry for hemoglobin and DNA adducts
- Author:
- Sagelsdorff P, Haenggi R, Heuberger B, Joppich-Kuhn R, Jung R, Weideli, HW, Joppich M
- Year:
- 1 996
- Bibliographic source:
- Carcinogenesis 17: 507-514
- Report date:
- 1996
Materials and methods
- Objective of study:
- other: bioavailability of the hypothetical cleavage product 3,3'-dichlorobenzidine (DCB) from the submission substance after oral application
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- investigation of formation of DCB-hemoglobin and DCB-DNA-adducts
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]
- EC Number:
- 225-822-9
- EC Name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]
- Cas Number:
- 5102-83-0
- Molecular formula:
- C36H34Cl2N6O4
- IUPAC Name:
- 2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(2,4-dimethylphenyl)-3-oxobutanamide]
- Test material form:
- not specified
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- 4 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.2% in diet (corresponding to 170 mg/kg bw)
- No. of animals per sex per dose / concentration:
- 6 females
- Control animals:
- no
- Positive control reference chemical:
- DCB, application via drinking water
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- - in three rats no DCB or AcDCB-hemoglobin adducts were detectable (limit of detection: 0.1 ng/g hemoglobin)
- in the remaining three animals adduct levels slightly higher than the individual detection limits for DCB and AcDCB of 0.1 ng/g hemoblobin were detected (total adduct levels < 0.24 - 0.41 ng/g hemoglobin)
- in 2/3 rats liver DNA-adducts slightly above the limit of detection (0.08 ng/g DNA) were detected (0.30 and 0.15 ng adducts/g DNA)
Any other information on results incl. tables
- no signs of toxicity were noticed during the 4 week treatment period
- food consumption and body weight development were similar in treated and in control animals
- the authors concluded that the DCB-adducts were due to the contamination of the test item with the monoazo compound
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: the test item is not metabolically splitted into DCB and no DCB becomes bioavailable after repeated oral application
The results indicate that the test item is not metabolically splitted into DCB and that no DCB becomes bioavailable after repeated oral application of the test item. Detection of minimal DCB-hemoglobin adducts in 3/6 rats and minimal DCB-DNA-adducts in the liver of 2/3 rats is probably due to the contamination of the test item with the monoazo compound. - Executive summary:
Female Wistar rats were treated for 4 weeks with 0.2% C.I. Pigment Yellow 13 in the diet. At the end of the exposure period. The hypothetical release of 3,3'-dichlorobenzidine was investigated by analysis of DCB-hemoglobin adducts and DCB-DNA-adduct levels in the liver. Minimal DCB-hemoglobin adducts in 3/6 rats and minimal DCB-DNA-adducts in the liver of 2/3 rats are probably due to the contamination of the test item with the monoazo compound. The results indicate that no DCB is bioavailable after oral ingestion of the test item.
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