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EC number: 457-630-8 | CAS number: 2138836-26-5
- 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: Based on available physico-chemical properties and toxicological data of the substance
- Adequacy of study:
- supporting study
- Study period:
- 2005 revised 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP assessment based on physico-chemical properties and toxicological data of the substance
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
- Objective of study:
- other: Toxicokinetic assessment
- Principles of method if other than guideline:
- An expert assessment was made based on physico-chemical properties and all toxicity data available
- GLP compliance:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 457-630-8
- EC Name:
- -
- Cas Number:
- 2138836-26-5
- Molecular formula:
- Hill formula: C29H23FN8Na4O16S5
- IUPAC Name:
- tetrasodium 3-amino-4-[(1E)-2-[4-({4-fluoro-6-[phenyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazen-1-yl]-5-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reactive Red F00-0314
Constituent 1
Administration / exposure
- Details on study design:
- A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data (i.e., acute oral toxicity, acute dermal toxicity, skin irritation, eye irritation, skin sensitisation, subacute (28 d) oral toxicity, bacterial reverse mutation test and in vitro chromosome aberration test) of the test substance.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The data of the acute dermal toxicity, dermal irritation and skin sensitisation test indicate low dermal permeability, owing to the fact that neither systemic toxicity nor irritating or sensitizing effects were observed. This is in accordance with the physico-chemical properties of the test substance. Oral resorption of the substance is probably also restricted due to the high molecular weight, high number of H-bond acceptors and low log Kow since most substances with a molecular weight > 500, H-bond acceptors >10 and log Kow < -0.5 are only marginally resorbed. However, after oral gavage the test substance was considered to get partially absorbed. This can be concluded from urine and faeces discolorations after single oral exposure and from data obtained in the subacute oral toxicity study using daily doses up to 1000 mg/kg bw/day, in which test compound related discolorations were observed in various tissues and organs. As the test substance is an azo dye, partial metabolic cleavage by bacterial azoreductases in the intestine resulting in more hydrophilic amines seems to be likely.
- Details on distribution in tissues:
- After resorption following repeated oral administration in high doses, temporarily distribution in kidneys, skin, testes, epididymides, and/or rectum is possible as demonstrated by test substance related discolorations.
- Details on excretion:
- Reddish discoloured faeces and urine after oral administration of the test substance indicated that the compound can be eliminated both via kidneys and via intestine as confirmed by corresponding organ discolorations (kidneys and rectum).
Any other information on results incl. tables
Evaluation and assessment:
The data of the acute dermal toxicity, dermal irritation and skin sensitisation test indicate low dermal permeability, owing to the fact that neither systemic toxicity nor irritating or sensitizing effects were observed. This is in accordance with the physico-chemical properties of the test substance. Oral resorption of the substance is probably also restricted due to the high molecular weight, high number of H-bond acceptors and low log Kow since most substances with a molecular weight > 500, H-bond acceptors >10 and log Kow < -0.5 are only marginally resorbed. However, after oral gavage the test substance was considered to get partially absorbed. This can be concluded from urine and faeces discolorations after single oral exposure and from data obtained in the subacute oral toxicity study using daily doses up to 1000 mg/kg bw/day, in which test compound related discolorations were observed in various tissues and organs. As the test substance is an azo dye, partial metabolic cleavage by bacterial azoreductases in the intestine resulting in more hydrophilic amines seems to be likely.
After resorption following repeated oral administration in high doses, temporarily distribution in kidneys, skin, testes, epididymides, and/or rectum is possible as demonstrated by test substance related discolorations. Reddish discoloured faeces and urine after oral administration of the test substance indicated that the compound can be eliminated both via kidneys and via intestine as confirmed by corresponding organ discolorations (kidneys and rectum). Test-item related discolorations showed no correlated physiological or histopathological findings (like precipitate) and therefore did not represent toxic effects. The fact that less animals and less organs were affected at the end of the recovery period compared with the end of the treatment period indicated that organ discolorations were reversible and that no accumulation of the chemical occurred. This was supported by the observation that urine discoloration was still observed in the recovery period indicating ongoing elimination of the test item and it was in accordance with the physico-chemical properties of the test substance (high water-solubility, low partition coefficient).
Applicant's summary and conclusion
- Conclusions:
- The test substance is expected to have partial oral absorption, low dermal absorption and no accummulation in the body. Excretion via urine and predominantly faeces can be expected.
- Executive summary:
A toxicokinetic assessment was conducted based on available physico-chemical properties and toxicological data of the test substance.
The data of the acute dermal toxicity, dermal irritation and skin sensitisation test indicate low dermal permeability, owing to the fact that neither systemic toxicity nor irritating or sensitizing effects were observed. This is in accordance with the physico-chemical properties of the test substance. Oral resorption of the substance is probably also restricted due to the high molecular weight, high number of H-bond acceptors and low log Kow since most substances with a molecular weight > 500, H-bond acceptors >10 and log Kow < -0.5 are only marginally resorbed. However, after oral gavage the test substance was considered to get partially absorbed. This can be concluded from urine and faeces discolorations after single oral exposure and from data obtained in the subacute oral toxicity study using daily doses up to 1000 mg/kg bw/day, in which test compound related discolorations were observed in various tissues and organs. As the test substance is an azo dye, partial metabolic cleavage by bacterial azoreductases in the intestine resulting in more hydrophilic amines seems to be likely.
For any test item that is absorbed following oral ingestion, the high water solubility should facilitate the distribution of the test substance throughout the body in the water compartment of circulatory systems. This assumption was confirmed by the discoloration of the serum and a distribution in kidneys, skin, testes, epididymides, and/or rectum as demonstrated by test substance related discolorations. However, the passage of test item across specialized biological membranes such as the blood/brain or blood/placental barrier will be subject to the same physical limitations (high molecular weight and low octanol: water partition coefficient) as with absorption from the gastro-intestinal tract and may therefore suggest that biological distribution will be inhibited across such biological structures. This suggestion may be supported by the lack of test item stained cellular structures such as brain identified from histopathological assessment of treated animals from the repeated dose toxicity study.
According to the molecular weight, Reactive Red F00-0314 is most likely predominantly eliminated via faeces – as it has been shown that substances with molecular weight above 300 g/mol are preferentially excreted via faeces in rats. However, as reddish discoloured faeces and urine after oral administration of the test substance in the acute and repeat-dose studies showed, a fraction of the absorbed test substance and most likely its metabolites are excreted via as confirmed by corresponding organ discolorations (kidneys and rectum). Test-item related discolorations showed no correlated physiological or histopathological findings (like precipitate) and therefore did not represent toxic effects.
Accumulation of the test substance in body fat is not expected due to the high water solubility and low octanol: water partition coefficient value. The fact that less animals and less organs were affected at the end of the recovery period compared with the end of the treatment period indicated that organ discolorations were reversible and that no accumulation of the chemical occurred. This was supported by the observation that urine discoloration was still observed in the recovery period indicating ongoing elimination of the test item and it was in accordance with the physico-chemical properties of the test substance (high water-solubility, low partition coefficient).
In sumary, the results of basic toxicity testing give no reason to anticipate unusual characteristics with regards to the toxicokinetics of Reactive Red F00-0314. The data indicate that there is little or no dermal absorption. No signs of a significant systemic toxicity associated with absorption through skin have been observed. Based on exposure model from AG Textilien des Bundesinstituts fur Risikobewertung (BfR), the dermal penetration rate for dyes through the skin was found to be less than 2%. Based on physico-chemical data and the results of oral toxicity studies, Reactive Red F00-0314 has a limited oral bioavailability.
The substance is considered to have low volatility as evident from the vapour pressure measurement and the calculated melting point of > 300°C, so the potential for the generation of inhalable forms is low. The molecular weight is higher than 500 g/mol and the chromophore is negative charged. This together with the high water solubility and low partition coefficient value, indicate the substance is not able to cross the mucous layer of the respiratory tract. Due to the high water solubility, vapours if generated/inhaled, will be trapped in the mucus of the respiratory tract, thereby further limiting the absorption. Hence, the main route of exposure of the substance, if inhaled, will be due to swallowing of particles deposited in the nose/mouth. Therefore, the bioavailability for inhalation is considered the same as for oral intake.
Bioaccumulation of Reactive Red F00-0314 can most probably be excluded due to the available data. Based on the results of genotoxicity assays, a metabolisation towards genotoxic metabolites can also be excluded for mammalian species.
The substance is therefore not considered to be of concern for ADME related effects.
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