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A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable)
EC number: 404-540-1 | CAS number: 159405-95-5 BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
- 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
Oral subacute toxicity study (28 -day) with rat: NOEL = 200 mg/kg bw/day; NOAEL = 1000 mg/kg bw/day.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study was performed according to OECD TG 407 and GLP.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Subacute toxicity via oral route
A study was run according to OECD guideline 407. The substance was administered daily by gavage to rats. The study was run with four dose groups, 0, 50, 200, and 1000 mg/kg/day.
At 50 and 200 mg/kg/day no treatment related findings were observed.
Following observations were made at 1000 mg/kg/day:
1) dark faeces and regurgitation of test substance.
2) decreased body weight gain in females.
3) decreased food consumption by females.
4) increased liver weight in females only.
Animals receiving 1000 mg/kg showed increased liver weights (although not statistically significant in males). However, as there were no changes in serum liver enzyme levels or pathological evidence to corroborate this, the toxicological significance of this change has to be considered doubtful. The decreased food consumption by females receiving 1000 mg/kg/day noted even after adjustment for body weight suggests a loss of appetite among these females rather than any impairment of metabolic function.
Given these slight, but unequivocal, indices of biological effect among animals treated at 1000 mg/kg/day, a no observed effect level (NOEL) was identified at 200 mg/kg/day, and the NOAEL at 1000 mg/kg bw.
Repeated dose toxicity via inhalation route
The inhalation route is appropriate if exposure of humans via inhalation is the most relevant route of human exposure taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
The very low vapour pressure applies to test item, as the study on vapour pressure determination was not run based on the high melting point > 300 °C. The particle size distribution shows D90 76.7 µm, D50 37 µm and less than 5 % < 10 µm, thus most particles belong to the inhalable fraction (10-100 µm). If inhaled, particles remain in the high part of the respiratory tract, from which they could be cleared out or enter the gastrointestinal tract. Possible toxic effects may be assessed in a toxicity study by oral route. Furthermore, significant human exposure to the substance via inhalable particles or droplets through the inhalation route is deemed to be unlikely due to the use of the substance in form of aqueous solutions as a dye.
Therefore, a study on repeated dose toxicity via the inhalation route was considered as not appropriate.
Repeated dose toxicity via dermal route
The dermal route is appropriate if the physico-chemical properties suggest potential for a significant rate of absorption through the skin.
Looking at the data set and the structure of the molecule, it can be postulated that this material has very little bioavailability by the dermal route. No systemic effects have been seen in an acute toxicity study up to a dose level of 2000 mg/kg bw; positive response was seen in 1 out of the 2 skin sensitisation studies, indicating bioavailability of the substance. However, as skin sensitisation is a non threshold effect, such evidence is not in contrast with the assumption of low absorption and bioavailability of the substance. Furthermore, local dermal effects caused by the substance have adequately been characterised via in vivo studies on skin sensitisation, skin and eye irritation and acute dermal toxicity. Overall, a study on repeatd dose toxicity via dermal route was considered as not appropriate.
Subchronic toxicity via oral route
The substance is poorly absorbable and has low toxicity, i.e. LD50 > 5000 mg/kg and NOAEL of 1000 mg/kg bw/day from 28-day repeated dose toxicity study and from developmental toxicity study. According to literature data and QSAR predictions, toxicity of azo-dyes is related to the potential release of aromatic amines upon cleavage of the diazo bonds in metabolic processes. There is no evidence of significant metabolism of the substance. Indeed, the release of the main metabolic products, such as those expected based on molecular structure as well as on QSAR predictions, would imply a high toxicity upon both acute and prolonged exposure, based on available data. None of these signs is seen upon exposure to target substance in various studies: acute toxicity study, 28-day repeated dose toxicity study, developmental toxicity study. Consequently, the formation of such metabolites is believed as not relevant under in vivo conditions. Physico-chemical features of the substance limit the absorption rate and thus the possibility of metabolism, in particular this is due to a high molecular weight (ca. 1090 g/mol), a high solubility in water (1:1 miscibile in water), a low partition coefficient (logPow < 0). In conclusion, a 90-day repeated dose toxicity study is not expected to modify the toxicological profile of the substance and further testing on vertebrate animals for this endpoint is proposed to be omitted.
Justification for classification or non-classification
Based on the experimental evidences in the assessment of the toxicity potential after repeated oral exposure, the test item does not need to be classified according to the CLP Regulation (EC 1272/2008).
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