Registration Dossier
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EC number: 224-867-1 | CAS number: 4531-49-1
- 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: 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
- Report Date:
- 2001
Materials and methods
- Objective of study:
- other: bioavailability of cleavage products
Test guideline
- Qualifier:
- equivalent or similar to
- Guideline:
- other: OECD Guideline 412 (Repeated Dose Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- e.g. no data on haematology, because the main subject of the study was the investigation of the bioavailability and not the investigation of toxicity after repeated exposure
- GLP compliance:
- yes
- Remarks:
- Performance and documentation was on the basis of GLP according to the German Chemikaliengesetz, but the test was not under supervision of the quality assurance unit
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:(WI)BR
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: about 3 month
- Weight at study initiation: about 430 g
- Fasting period before study: no data
- Housing: Makrolon cages
- Individual metabolism cages: yes
- Diet: Altromin Pellet-Feed (1324N) or Altromin no Pellet-Feed (1321N) ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 40-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Administration / exposure
- Route of administration:
- other: intratracheal instillation
- Vehicle:
- other: suspension in isotonic saline containing 1% (w/v) Tween 80
- Details on exposure:
- - intratrachel instillation of 0.3 ml of suspension
- Duration and frequency of treatment / exposure:
- once per week for 4 consecutive weeks (day 1, 8, 15, 22 and 29 of the experiment)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 20 mg/animal per application
- No. of animals per sex per dose:
- 12 males per group in the control and test substance group (6 of the animals were sacrificed on day 31 and 6 animals survived till the end of the 4 weeks post exposure period)
- 6 males in the positive control group - Control animals:
- yes, concurrent vehicle
- Positive control:
- 5 times 7.31 mg 3,3'-dichlorobenzidine (CAS 91-94-1) or 5 times 5,6 mg Direct Red 46 (CAS 6548-29-4) per animal
- Details on study design:
- - Dose selection rationale: ascertainment of the maximum tolerable dose in a pretest
- Details on dosing and sampling:
- BIOAVAILABILITY STUDY
- Tissues and body fluids sampled: urine, faeces, blood, organs (lung, liver, spleen, kidney, urinary bladder, gastro intestinal tract, mamma)
- Time and frequency of sampling of urine and faeces: on day 1, 2, 3, 7, 8, 9, 14, 15, 16, 21, 22, 23, 28, 29, 30 for the animals which were sacrificed on day 31
- Time and frequency of sampling of urine and faeces: on day 28, 29, 30, 35, 42, 49, 56 for the animals which were sacrificed on day 57 at the end of the post exposure period
- Time and frequency of sampling of blood and organs: after sacrifice on day 31 or 57 - Statistics:
- no data
Results and discussion
Any other information on results incl. tables
3,3'-Dichlorobenzidine was not detectable in urine, faeces or bound to haemoglobin after acid hydrolysis of the matrices.
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Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: the test substance has a high potential to persist in the lung due to the significantly limited clearance capacity of the lung as a consequence of the particle overload; no 3,3'-dichlorobenzidine is bioavailable from the test substance
Analysis of urine, faeces and haemoglobin revealed that no 3,3'-dichlorobenzidine is liberated from the test substance after intratracheal instillation. - Executive summary:
Male Wistar rats were exposed for five times to 10 or 20 mg test item/animal by intratracheal instillation at weekly intervals. Urine and faeces were collected during the exposure and 28 days observation period, blood was collected at the end of the exposure and post observation period. Urine, faeces and haemoglobin were analysed for the presence of 3,3'-dichlorobenzidine after acid hydrolysis, the pigment content of the lungs was determined gravimetrically and the lungs and lung associated lymph nodes were investigated histopathologically. The pigment was deposited in the lung and persisted in the lung during the observation period. No 3,3'-dichlorobenzidine was detectable in the urine, faeces and haemoglobin of treated rats during the exposure period. Traces of 3,3'-dichlorobenzidine were detected in control animals, probably due to impurities of the analytical instruments.
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