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EC number: 210-323-0 | CAS number: 612-83-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 02 APR 2009 to 28 APR 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 423; EU Method B.1. tris)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3'-dichlorobenzidine dihydrochloride
- EC Number:
- 210-323-0
- EC Name:
- 3,3'-dichlorobenzidine dihydrochloride
- Cas Number:
- 612-83-9
- Molecular formula:
- C12H10Cl2N2.2ClH
- IUPAC Name:
- 3,3'-dichloro-[1,1'-biphenyl]-4,4'-diamine dihydrochloride
- Details on test material:
- - Name of test material (as cited in study report): 3,3'-Dichlorbenzidin-dihydrochlorid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd., Füllinsdorf, Switzerland
- Age at study initiation: 11 weeks
- Weight at study initiation: 181.1-200.9 g
- Fasting period before study: yes (overnight)
- Housing: in groups of three in Makrolon type-4 cages
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland); ad libitum except for fasting period (overnight prior to intubation and approximately 3-4 hours post dose)
- Water: community tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE (Polyethylene glycol 300: PEG 300)
- Concentration in vehicle: 0.2 g/mL
- Justification for choice of vehicle: vehicle selected, because test item was not soluble in purified water
- Lot/batch no.: S41673-128
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: shortly before dosing
CLASS METHOD
- Rationale for the selection of the starting dose: The dose of 2000 mg/kg bw was selected as available information point towards a low acute toxicity. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 females (two groups of 3 females)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: on test days 1 (prior to administration), 8 and 15
- Frequency of observations: daily during acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1, depending on the occurrence of clinical signs of toxicity; once daily during days 2-15
- Necropsy of survivors performed: yes - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: none of the animals died during the 14 day observation period
- Mortality:
- - none
- Clinical signs:
- other: - slight sedation, ocular opacity and slightly ruffled fur were observed in all animals from the first 30 minutes or 1 hour observation and persisted up to test day 3 at latest - hunched posture was seen in all animals from the 2- or 3-hour reading up to
- Gross pathology:
- - no macroscopic findings at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- 3,3'-Dichlorbenzidine dihydrochlorid does not cause lethality in female rats after single oral application of 2000 mg/kg bw, resulting in a LD50 of > 2000 mg/kg bw.
- Executive summary:
Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with 3,3'-Dichlorbenzidine-dihydrochlorid by oral gavage administration at a dosage of 2000 mg/kg bodyweight. The test item was formulated in PEG 300 at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs during the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded during the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period.
Several clinical signs, such as slight sedation, ocular opacity and slightly ruffled fur were observed from the first 30 minutes or 1-hour observation and persisted up to test day 3 at the latest. Hunched posture was seen in all animals from the 2- or 3-hour reading up to the 5-hour reading or test day 2. Additionally, in two animals cyanosis was noted from the 5-hour observation to test day 2. Thereafter, all animals were free of clinical signs until test day 15, the end of observation.
The body weight of the animals was within the range commonly recorded for rats of this strain and age.
No macroscopic findings were recorded at necropsy.
The median lethal dose of 3,3'-Dichlorbenzidine-dihydrochlorid after single oral administration to female rats, observed over a period of 14 days is:
LD50 (female rat): greater than 2000 mg/kg body weight
LD50 cut-off: infinite
In mg/kg b.w., according to ANNEX 3 of Regulation (EC) No 1907/2006, B. 1 tris.
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