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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
Endpoint summary
Administrative data
Description of key information
After single oral application of > 2000 mg/kg bw to female rats no lethality was observed.
Key value for chemical safety assessment
Additional information
Single oral application of 2000 mg/kg bw 3,3'-dichlorobenzidine dihydrochloride to female rats in a reliable guideline study did not result in the death of any animal. This finding is supported by other studies, which were judged not to be reliable (RL 3) due to insufficient documentation: These studies reported rat oral LD50 values of 3820 mg/kg bw and 7070 mg/kg bw for the dihydrochloride and free base, respectively. Lower LD50 values (females: 488 mg/kg bw; males: 676 mg/kg bw) were only reported in a study performed with mice. The reliability of this study could not be evaluated, because results were only availably from a secondary source.
In an acute inhalation study with rats, which were exposed for 1 hour to concentrated dust of the submission substance no deaths were reported during the 14 day observation period. This study was judged not to be reliable (RL 3) due to insufficient reporting.
Data on acute toxicity after dermal application are only available from two studies using the free base of the submission substance.The results of these studies are contradictory: One of these studies reported an dermal LD50 value of > 8000 mg/kg bw for rabbits (study not reliable due to insufficient documentation; RL 3), whereas in the other study 4 of 5 rabbits died after single dermal application of 1000 mg/kg bw (results only available from secondary source; RL 4).
In summary, reliable data on the acute toxicity of the submission substance are only available after single oral application, indicating that the oral LD50 in rats is > 2000 mg/kg bw. Further studies, which were not reliable due to insufficient documentation, indicated that the submission substance has no or only very low acute toxicity after oral, inhalative or dermal exposure, not relevant for classification. Two studies, which were only available from secondary sources, pointed to some acute toxicity after single oral or dermal application. It is concluded that the submission substance has not to be classified for acute toxicity after oral, inhalative or dermal application according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.
Justification for classification or non-classification
Reliable data on the acute toxicity of the submission substance are only available after single oral application, indicating that the oral LD50 in rats is > 2000 mg/kg bw. Further studies, which were not reliable due to insufficient documentation, indicated that the submission substance has no or only very low acute toxicity after oral, inhalative or dermal exposure, not relevant for classification. Two studies, which were only available from secondary sources, pointed to some acute toxicity after single oral or dermal application. It is concluded that the submission substance has not to be classified for acute toxicity after oral, inhalative or dermal application according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC.
For the existing classification given in Annex VI to Regulation (EC) No 1272/2008 (R21, H312), which deviats from the justification above, no rationale is available. In the absence of reliable contrary data and for precautionary reasons this classification is retained.
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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