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Diss Factsheets
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EC number: 274-397-6 | CAS number: 70209-99-3
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- Expert assessment
- Type of information:
- other: Expert assessment
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Objective of study:
- toxicokinetics
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Expert assessment
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name: FAT 92349/B
- Conclusions:
- From the information provided it has been concluded the risk of systemic toxicity from FAT 92349/B would be minimal.
- Executive summary:
The absorption, distribution, metabolism and excretion of FAT 92349/B has been predicted based on the physico-chemical properties and supporting toxicological information provided for FAT 92349/B. FAT 92349/B is a highly water soluble reactive dye and on this basis it is reasonable to conclude that absorption following oral (gavage) administration would be via the gastro-intestinal tract with subsequent systemic distribution expedited in serum. Furthermore, as characteristically reactive dyes are designed to bind with the majority of chemical groups and substrates there is also the possibility some absorption could occur through damaged skin facilitating test item systemic distribution through binding to carrier proteins in the circulatory system. The physico-chemical properties in particular particle size would indicate the risk of inhalation of the test item to be minimal and the supporting toxicological information suggests that were any to occur, no elevated toxicity would be anticipated. There was no evidence to indicate how FAT 92349/B or any of its intermediate products are metabolised however the hydrophilic nature and molecular weight of FAT 92349/B and or its metabolites would suggest passage across biological membranes would be limited. Furthermore, the histopathological evidence derived from an Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test in the Rat (OECD 422) using a similar test material to FAT 92349/B provided no evidence of test item or metabolite influenced hepatic metabolism. In consideration of the chemical attributes of FAT 92349/B and supporting toxicological evidence the route of clearance is considered to be via the urine with any remaining test item not absorbed excreted in the faeces. Based on review of the available information it has been concluded that the risk of systemic toxicity from FAT 92349/B would be minimal.
Reference
TOXICOKINETIC BEHAVIOUR
The substance composed, as listed in Section 3 is a blue solid with a molecular weight of 666.39 g/mol and high water solubility (57.8 g/L) plus high melting and auto-ignition points together with a low log octanol/water partition coefficient value (Log10 Pow -3.33). These physico-chemical properties together with the particle size fractions indicate the risk of inhalation of FAT 92349/B to be minimal. A chemically related structure to FAT 92349/B was shown to be mutagenic in a bacterial assay with or without S9 mixture activation but non-clastogenic in an in vivo micronucleus assay. The results from a repeated dose reproductive screening study using a similar chemical structure to FAT 92349/B was shown to have no observed adverse effect on systemic toxicity or effects on reproductive performance/offspring development up to a dose level of 1000 mg/kg bw/day.
Absorption
FAT 92349/B was indicated to be highly water soluble and would therefore be bioavailable through absorption via the gastrointestinal tract subsequently entering the circulatory system in the blood. This premise was supported in the Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction /Developmental Toxicity Screening Test in the Rat (OECD 422) in which evidence of blue colouration (presumably from the test item and or its metabolites) was observed externally on the skin and fur and in internal tissues (kidneys, thymus, female reproductive tract and alimentary canal). However, in consideration of the hydrophilic nature and molecular weight of FAT 21036/G passage across biological membranes is likely to be limited.
Distribution
Due to the high water solubility of FAT 92349/B systemic distribution is considered most likely to occur via the serum. This opinion was further supported by the data derived from the Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction /Developmental Toxicity Screening Test in the Rat (OECD 422) in which test item or metabolite staining of external and internal organs was observed together with blue stained faeces and bedding. There was no supporting evidence to indicate test item deposition in body fat.
Metabolism
A closely related chemical structure to FAT 92349/B exerted a clear mutagenic action. This effect was less pronounced when metabolic activation mixture (S9) was added. However, this isolated result may not necessarily reflect human metabolism and there was no evidence from the Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction /Developmental Toxicity Screening Test in the Rat (OECD 422) to indicate test item or metabolite influenced hepatic metabolism.
Excretion
Based on the available evidence including blue stained faeces and bedding observed in the Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction /Developmental Toxicity Screening Test in the Rat (OECD 422) together with the high water solubility of FAT 92349/B; biliary excretion is unlikely and the primary route of clearance would be via the urine with any remaining test item not absorbed being excreted in the faeces.
CONCLUSION
From the information provided it has been concluded the risk of systemic toxicity from FAT 92349/B would be minimal.
Description of key information
The absorption, distribution, metabolism and excretion of FAT 92349/B TE has been predicted based on the physico-chemical properties and supporting toxicological information provided for FAT 92349/B. FAT 92349/B is a highly water-soluble reactive dye and on this basis it is reasonable to conclude that absorption following oral (gavage) administration would be via the gastro-intestinal tract with subsequent systemic distribution expedited in serum. Furthermore, as characteristically reactive dyes are designed to bind with the majority of chemical groups and substrates there is also the possibility some absorption could occur through damaged skin facilitating test item systemic distribution through binding to carrier proteins in the circulatory system. The physico-chemical properties in particular particle size would indicate the risk of inhalation of the test item to be minimal and the supporting toxicological information suggests that were any to occur, no elevated toxicity would be anticipated. There was no evidence to indicate how FAT 92349/B or any of its intermediate products are metabolised however the hydrophilic nature and molecular weight of FAT 92349/B and or its metabolites would suggest passage across biological membranes would be limited. Furthermore, the histopathological evidence derived from an Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test in the Rat (OECD 422) using a similar test material to FAT 92349/B provided no evidence of test item or metabolite influenced hepatic metabolism. In consideration of the chemical attributes of FAT 92349/B and supporting toxicological evidence the route of clearance is considered to be via the urine with any remaining test item not absorbed excreted in the faeces. Based on review of the available information it has been concluded that the risk of systemic toxicity from FAT 92349/B would be minimal.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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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