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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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:
- 3.65 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:
- 109.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Due to particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Hence NOAEL for oral toxicity is considered the appropriate endpoint for hazard assessment. Therefore oral absorption in rat is assumed to be 100% and inhalation absorption in humans is assumed to be 100%. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. Allometric scaling factor: 4; BW (human) = 70 kg Hrv = Human respiration rate = 10 m3 / person. Therefore, corrected NOAEC (inhalation) = 109.4 mg/m3 (62.5/4 * 70/10)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 700 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 500 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Due to particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Hence NOAEL for oral toxicity is considered the appropriate endpoint for hazard assessment. Therefore oral absorption in rats is assumed to be 100% and inhalation absorption in rats is assumed to be 100%. Guidance on information requirements and chemical safety assessment; Chapter R.7a: Endpoint specific guidance, section R.7.4.5.2 Concluding on suitability for Chemical Safety Assessment for acute toxicity states that when a limit test has been conducted, and no adverse effects on health have been observed, then the limit dose can be regarded as the NOAEL. Allometric scaling factor: 4 BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. = 2000 / 4 * 70/10 = 3500 mg/m3. For workers (in case of 8 hour exposure / day).
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 1.04 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:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Assume that oral absorption in rat is 100% and dermal absorption in humans is 50% as worst case.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat compared with humans is 4
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 100 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat compared with humans is 4
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor of 5 for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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 test substance does not have any local irritating or sensitizing effects in animals. There are no inhalation data available for the substance. By extrapolation it is possible to calculate systemic DNELS for short term and some long term exposure; however calculation of local DNELS on the basis of the available data does not seem to be reasonable, as the substance is not classified for toxicological effects.
Given that exposure considerations for skin and eye exposure in the dyeing industry where the substance is used can be stated as negligible and prevented, it is therefore the consideration of the registrant that quantitative local effects based on animal data cannot be conducted. Instead, qualitative assessments of acute/short term and long term effects have instead been conducted, based on the data available. By extrapolation it is possible to calculate systemic DNELS for short term and some long term exposure; however calculation of local DNELS for local effects on the basis of the available data does not seem to be reasonable, as the substance is not classified for toxicological effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.91 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:
- 54.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Due to particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Therefore, 100% oral absorption in rats is assumed and 100% inhalation absorption in humnas is assumed. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. Allometric scaling factor: 4; BW (human) = 70 kg Hrv = Human respiration rate = 20 m3 / person. Therefore, corrected NOAEC (inhalation) = 54.7 mg/m3 (62.5/4 * 70/20)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor of 10 for general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 350 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 500 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Due to particle size distribution, inhalable / respirable particles are negligible. Any nuisance dust ingested will remain in the mouth/nose with the potential for subsequent oral exposure. Hence NOAEL for oral toxicity is considered the appropriate endpoint for hazard assessment. Therefore oral absorption in rats is assumed to be 100% and inhalation absorption in rats is assumed to be 100%. Guidance on information requirements and chemical safety assessment; Chapter R.7a: Endpoint specific guidance, section R.7.4.5.2 Concluding on suitability for Chemical Safety Assessment for acute toxicity states that when a limit test has been conducted, and no adverse effects on health have been observed, then the limit dose can be regarded as the NOAEL. Allometric scaling factor: 4 BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. Corrected NOAEC (inhalation) = NOAEL (oral rat) / AS * BW(human) / Hrv. = 2000 / 4 * 70/10 = 3500 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling done at route to route extrapolation step in accordance with left hand side of Example R. 8-2 of Appendix R. 8-2, part 1.
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor of 10 for general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 0.52 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:
- 125 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Assume that oral absorption in rat is 100% and dermal absorption in humans is 50% as worst case.
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat compared with humans is 4
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general opoulation is 10
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaning uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat compared with humans is 4
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 0.26 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:
- 62.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat compared with humans is 4
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor when the starting point for the DNEL calculation is a NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rat compared with humans is 4
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling factor considered sufficient to account for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP study conducted in accordance with OECD Guideline.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The test substance is not classified for any local irritating or sensitizing effects in animals. There are no inhalation data available for the substance. By extrapolation it is possible to calculate systemic DNELS for short term and some long term exposure; however calculation of local DNELS on the basis of the available data does not seem to be reasonable, as the substance is not classified for toxicological effects.
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.