Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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Reaction mass of 5,5'-{(phenylmethanediyl)bis[benzene-4,1-diyl-diazene-2,1-diyl]}bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride and 5,5’-[3,4’-(phenylmethanediyl)diphenylene]bis(diazene-2,1-diyl)bis{1-[3-(dimethylamino)propyl]-4-methyl-6-oxo-3-(pyridinium-1-yl)-1,6-dihydropyridin-2-olate} hydrochloride
EC number: 700-312-3 | CAS number: -
- 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
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- 2011-01-17 to 2012-05-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. Expert statement based on all study results available for target compound (substance registred) and source (analogue) chemical.
Data source
Reference
- Reference Type:
- other: expert statement
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The Toxicokinetic Assessment is meant to fulfil the requirement as defined in the REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 requests in Annex VIII, point 8.8.1:
"Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from the relevant available information." - GLP compliance:
- no
Test material
- Reference substance name:
- Analogue substance
- IUPAC Name:
- Analogue substance
Constituent 1
- Radiolabelling:
- no
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: no bioaccumulation based on expert statement evaluating the available data
Based on the available data there is no indication for a critical bioaccumulation potential of the registered substance. - Executive summary:
Data on the toxicokinetics of the registration substance are not available. However, toxicity data indicate that this compound and/or metabolites are absorbed from the gastro-intestinal tract following oral administration. Direct evidence in the form of plasma data is not available. Dermal absorption of the registration substance is expected to be low. This view of limited penetration is supported by the molecular weight (> 500) and a log Pow of about -1.4 at 23 °C, which is in line with appendix R.7.12-4 of the REACH endpoint guidance R.7. as well as by data from a dermal toxicity study which revealed no specific acute systemic toxicity at the limit doses of 2000 mg/kg body weight in rats. Due to the very low vapour pressure of the registration substance, inhalation is not a major exposure route of concern.
The systemic effects stated above indicate that the substance is distributed throughout the body after oral absorption. Due to the high water solubility and the low partition coefficient accumulation in fatty tissues is very unlikely.
As the compound features already high water solubility it is questionable whether it is extensively metabolised. The finding that urine and faeces were coloured yellow in the repeated dose study with the analogue substance support the conclusion that large amounts of the substance registered are not metabolised and excreted via urine and feces. Possible metabolic reactions are cleavage of the azo-group by azo-reductase, epoxidation of arenes, demethylation of tertiary amino groups and formation of quinone-type chemicals. A recently performed Ames test for azo-dyes with the substance registered (according to Prival modification, i.e. with Hamster S9) demonstrated a negative result. Therefore, there is no evidence for a reductive reconstruction of the azo-dye by bacteria. Phase-II-metabolism might include acetylation of amine groups, sulfatation or UDPglucuronidation of hydroxy/phenol-moieties. Metabolites generally would have high water solubility and thereby good characteristics for excretion.
As the substance registered is highly water soluble urinary excretion is most likely. Based on the available data there is no indication for a critical bioaccumulation potential of the substance registered.
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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