Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 428-480-0 | CAS number: 214559-61-2 COLORANT Y-1189; DUASYN; DYE Y-1189; FARBSTOFF Y-1189; Y-1189; Y-1189L
- 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:
- 7 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:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation NOAEC = 600 x (1/0.38) x (50/100) x (6.7/10) = 529 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required. Taken into account in conversion of oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default intraspecies factor for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- 10 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:
- 3 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL = 600 mg/kg x (50/10) = 3000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies allometric factor for extrapolating from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default intraspecies factor for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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
The material was not acutely toxic via the oral or dermal route and is not anticipated to be acutely toxic via the inhalation route.
Two repeat dose toxicity studies are available: A 28 day repeat dose oral study in rats, and an OECD 421 oral study in rats. In absence of adverse effects in these studies, the NOAELs were set at the highest doses tested These NOAELs were 1000 mg/kg bw/day for parental, reproductive and developmental effects in the OECD 421 study (Petus – Árpásy, 2014; summarised at 7.8.1 and 7.8.2 (Dossier) / 5.9.1 (CSR)) and 600 mg/kg bw/day in an OECD 407 study (Lortie, 2002; Summarised at 7.5.1 (Dossier) / 5.6.1 (CSR)). In deriving the DNEL, the 600 mg/kg NOAEL is used as the OECD 407 study covers endpoints that the OECD 421 does not. The OECD 421 study gives an indication of an absence of reproductive findings and maternal toxicity at upto 1000 mg/kg bw/day.
The test material was not genotoxic, or toxic to reproduction in the OECD 421 study.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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:
- 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation NOAEC = 600 x (1/1.15) x (50/100) = 261 mg/m3/day
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required. Taken into account in conversion of oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- 5 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:
- 3 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dermal NOAEL = 600 mg/kg x (50/10) = 3000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies allometric factor for extrapolating from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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:
- 1 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:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation required.
- AF for dose response relationship:
- 1
- Justification:
- Not required. Clear NOAELs established.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subchronic to chronic duration.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies allometric factor for extrapolating from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Data sufficient for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
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
The material was not acutely toxic via the oral or dermal route and is not anticipated to be acutely toxic via the inhalation route.
Two repeat dose toxicity studies are available: A 28 day repeat dose oral study in rats, and an OECD 421 oral study in rats. In absence of adverse effects in these studies, the NOAELs were set at the highest doses tested These NOAELs were 1000 mg/kg bw/day for parental, reproductive and developmental effects in the OECD 421 study (Petus – Árpásy, 2014; summarised at 7.8.1 and 7.8.2 (Dossier) / 5.9.1 (CSR)) and 600 mg/kg bw/day in an OECD 407 study (Lortie, 2002; Summarised at 7.5.1 (Dossier) / 5.6.1 (CSR)). In deriving the DNEL, the 600 mg/kg NOAEL is used as the OECD 407 study covers endpoints that the OECD 421 does not. The OECD 421 study gives an indication of an absence of reproductive findings and maternal toxicity at upto 1000 mg/kg bw/day.
The test material was not genotoxic, or toxic to reproduction in the OECD 421 study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
