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Registration Dossier
Diss Factsheets
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EC number: 432-080-1 | 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:
- 58.8 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):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC corr = (NOAEL oral/vSRrat) X (vSR human / vWSRhuman) = (1000/0.38) x (6.7/10)
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable (accounted for by respiratory volumes)
- AF for other interspecies differences:
- 1
- Justification:
- Covered by allometric scaling
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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:
- 16.67 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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- [(NOAELoral rat x (ABSoral-rat/ABSderm-human)] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration) -response for human health’); where: NOAELoral rat = 1000 mg/kg bw/day; ABSoral-rat = 100%; ABSderm-rat = ABSderm-human = 50%).
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Covered by allometric scaling
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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:
Slight increases in bilirubin and protein levels in males and slightly increased leukocyte counts in females were observed after oral administration of Reaktiv-Orange DYPR 1410 (28 times during 29 days) at the dose level of 1000 mg/kg body weight per day. However, there were neither histopathological changes nor evidence for anaemia or an impairment of liver function. Therefore, the above-mentioned findings are considered not to be of major toxicological relevance. Additionally, salmon pink discoloured urine occurred in males at this dose level, probably due to the colour of the test compound and/or its metabolites.
No compound-related effect was observed after repeated administration of Reaktiv-Orange at the daily dose levels of 62.5 and 250 mg/kg body weight in both sexes.
With regard to this result, the 'No Observed Effect Level' (NOEL) is 250 mg/kg body weight in males and females. However, no clear toxic effects were observed at the dose level of 1000 mg/kg per day, so it considered appropriate to base the hazard assessment on the NOAEL for this substance.
There is no data available that would indicate a specific concern for the inhalation and dermal route. Thus, route-to-route extrapolation is justified.
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.
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:
- 29.4 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):
- 60
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC corr = (NOAEL oral/vSRrat) X (vSR human / vWSRhuman) = (1000/0.38) x (6.7/10)
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Metabolic differences are already accounted for in the route to route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Covered by allometric scaling
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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:
- 8.33 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):
- 240
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- [(NOAELoral rat x (ABSoral-rat/ABSderm-human)] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration) -response for human health’); where: NOELoral rat = 1000 mg/kg bw/day; ABSoral-rat = 100%; ABSderm-rat = ABSderm-human = 50%).
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Covered by allometric scaling
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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:
- 4.17 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):
- 240
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not applicable
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Covered by allometric scaling
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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:
Slight increases in bilirubin and protein levels in males and slightly increased leukocyte counts in females were observed after oral administration of Reaktiv-Orange DYPR 1410 (28 times during 29 days) at the dose level of 1000 mg/kg body weight per day. However, there were neither histopathological changes nor evidence for anaemia or an impairment of liver function. Therefore, the above-mentioned findings are considered not to be of major toxicological relevance. Additionally, salmon pink discoloured urine occurred in males at this dose level, probably due to the colour of the test compound and/or its metabolites.
No compound-related effect was observed after repeated administration of Reaktiv-Orange at the daily dose levels of 62.5 and 250 mg/kg body weight in both sexes.
With regard to this result, the 'No Observed Effect Level' (NOEL) is 250 mg/kg body weight in males and females. However, no clear toxic effects were observed at the dose level of 1000 mg/kg per day, so it considered appropriate to base the hazard assessment on the NOAEL for this substance.
There is no data available that would indicate a specific concern for the inhalation and dermal route. Thus, route-to-route extrapolation is justified.
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.
Overall, a low hazard potential is concluded for the test item.
For consumer uses, it has to be considered that due to the chemical reaction of the dye with the fabric during the dyeing process, the test substance is covalently bound to the textile. It is therefore unlikely that the consumer is exposed to the dye from contact to the dyed textile. For home-dyeing, consumer use is restricted to dyeing with the washing machine (closed system). The preparation provided for home-dyeing is designed in a way that exposure of the consumer to the powder can be excluded. A consumer exposure to the test substance can therefore be omitted.
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.

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