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Reaction mass of copper complex of [(2,6-difluoroheterocycl-4-yl)amino]hydroxy{[2-hydroxy-3-sulfonato-5-(vinylsulfonyl)phenyl]diazenyl}naphthalene sulfonic acid, dialkali salt and copper complex of [(2,6-difluoroheterocycl-4-yl)amino]-hydroxy{[2-hydroxy-3-sulfonato-5-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl]diazenyl}naphthalene sulfonic acid, trialkali salt
EC number: 479-550-2 | 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
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:
- 2.35 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on inhalation is available. Thus route-to-route extrapolation has been performed. There is no data available that would indicate a specific concern for the inhalation route, that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable (accounted for by respiratory volumes)
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default for worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 0.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal long-term study is available. Thus route-to-route extrapolation has been performed. There is no data available that would indicate a specific concern for the dermal route, that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default (worker)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
Repeated dose toxicity & systemic effects:
Base for deriving systemic long-term DNELs is a 28 day oral toxicity study in SD rats (Kauffmann, 2003). The test item was well tolerated and resulted in no deaths or severe clinical symptoms. Neurotoxicological examination, hematology and clinical chemistry values as well as urinalysis and histopathological investigation showed no substance related or biologically relevant alterations in all dose groups. Animals in the high dose group (800 mg/(kg/d) showed squatting posture and/or stilted gait at the end of the treatment period. Female animals of the high dose group showed additionally slightly reduced body weight gains during the treatment period (14 %), slightly decreased absolute liver weights as well as slightly increased relative spleen weights. However, these changes were reversible and normalized after the recovery period. The NOAEL is 200 mg/kg bw/day, the LOAEL is 800 mg/kg/d.
There is no data available that would indicate a specific concern for the inhalation and dermal route. Thus, route-to-route extrapolation is justified. ECHA guidance values have been used for accounting possible differences in the route-specific absorption rates (dermal = oral and inhalation = 200% oral).
The test item is considered not to have any sensitizing properties in a GLP guideline study in guinea pigs.
Acute toxicity & local effects:
According to ECHA guidance there is no established accepted methodology to derive no-effect-levels for acute toxicity. It is considered not only cumbersome and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to ensure that effects do not occur. It is proposed that a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures. The test item is not classified for acute toxicity based on a LD50> 2000 mg/kg/d for the oral and dermal route.
Data on skin irritation/corrosion and eye irritation in vivo suggest a low hazard potential with regards to local effects.
The test substance led to persistent discoloration of conjunctivae, which resulted in classification of "potential risk of serious damage to eyes" according to the classification criteria of Directive 2001/59/EC. However, the irreversible discoloration of the conjunctiva is not considered an adverse effect according to Regulation (EC) 1272/2008, as this discoloration does not lead to an impaired sight
Overall, a low hazard potential is concluded for the test item.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 86.96 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No long-term study on inhalation is available. Thus route-to-route extrapolation has been performed. There is no data available that would indicate a specific concern for the inhalation route, that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable (accounted for by respiratory volumes)
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal long-term study is available. Thus route-to-route extrapolation has been performed. There is no data available that would indicate a specific concern for the dermal route, that would invalidate this approach.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (rat)
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (rat)
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
Repeated dose toxicity & systemic effects:
Base for deriving systemic long-term DNELs is a 28 day oral toxicity study in SD rats (Kauffmann, 2003). The test item was well tolerated and resulted in no deaths or severe clinical symptoms. Neurotoxicological examination, hematology and clinical chemistry values as well as urinalysis and histopathological investigation showed no substance related or biologically relevant alterations in all dose groups. Animals in the high dose group (800 mg/(kg/d) showed squatting posture and/or stilted gait at the end of the treatment period. Female animals of the high dose group showed additionally slightly reduced body weight gains during the treatment period (14 %), slightly decreased absolute liver weights as well as slightly increased relative spleen weights. However, these changes were reversible and normalized after the recovery period. The NOAEL is 200 mg/kg bw/day, the LOAEL is 800 mg/kg/d.
There is no data available that would indicate a specific concern for the inhalation and dermal route. Thus, route-to-route extrapolation is justified. ECHA guidance values have been used for accounting possible differences in the route-specific absorption rates (dermal = oral and inhalation = 200% oral).
The test item is considered not to have any sensitizing properties in a GLP guideline study in guinea pigs.
Acute toxicity & local effects:
According to ECHA guidance there is no established accepted methodology to derive no-effect-levels for acute toxicity. It is considered not only cumbersome and resource-intensive but probably unnecessary, as the long-term DNEL is normally sufficient to ensure that effects do not occur. It is proposed that a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures. The test item is not classified for acute toxicity based on a LD50> 2000 mg/kg/d for the oral and dermal route.
Data on skin irritation/corrosion and eye irritation in vivo suggest a low hazard potential with regards to local effects.
The test substance led to persistent discoloration of conjunctivae, which resulted in classification of "potential risk of serious damage to eyes" according to the classification criteria of Directive 2001/59/EC. However, the irreversible discoloration of the conjunctiva is not considered an adverse effect according to Regulation 1272/2008, as this discoloration does not lead to an impaired sight
Overall, a low hazard potential is concluded for the test item.
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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