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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 219-091-5 | CAS number: 2353-45-9
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 89.957 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 70
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 6 296.986 mg/m³
- AF for intraspecies differences:
- 5
- Justification:
- worker default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 51.02 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 571.425 mg/kg bw/day
- AF for intraspecies differences:
- 5
- Justification:
- worker default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Toxicokinetics:
In an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the colorFD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats.None of the colors was found in the urine.The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color.
Thus, it can be concluded that the color FD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential. There are certain reports though which indicate that these colorsare capable of producing tumors in rats at the site of subcutaneous injections repeated over periods of months.
Acute Toxicity (Oral, Dermal, Inhalation):
From the data available for the target chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt, it is concluded that the chemical is not likely to exhibit acute toxicity by the oral, inhalation and dermal route of exposure. Thus, the chemical is not classified for acute toxicity by either of the 3 routes of exposure.
Irritation effect (Skin & Eye):
From the data available for the target chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt, it is concluded that the chemical is not likely to cause irritation to skin and eyes. Thus, the chemical is not classified for skin and eye irritation.
Skin sensitization:
Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene] (3-sulphonatobenzyl)ammonium, disodium salt is estimated to be non-sensitising in a Guinea pig maximisation test.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22.183 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 140
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 105.587 mg/m³
- AF for intraspecies differences:
- 10
- Justification:
- general population default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25.51 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 140
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 571.425 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- General population default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.755 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 140
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 785.713 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- general population default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNEL derivation
From the data available for the target chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino] (4-hydroxy-2-sulphonatobenzhydrylidene] cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt, it is concluded that the chemical is not likely to exhibit acute toxicity by the oral, inhalation and dermal route of exposure. Thus, the chemical is not classified for acute toxicity by either of the 3 routes of exposure. The chemical is also not likely to exhibit toxic effects by the repeated oral route of exposure. The chemical is not likely to be carcinogenic. It is however likely to have mutagenic effects
A standard approach to deriving DNEL values has been to use the carcinogenecity dataset (oral route) and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 7142.857 mg/kg bw/d in oral category.
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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