Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 418-220-4 | CAS number: - RED JB 747
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 176.32 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL from oral repeated dose toxicity study (28 days) in rats was selected as the most representative starting dose based on: study duration, presence of adverse effects, parameters observed.
Starting from an oral NOAEL, a corrected value is obtained considering: 8h- breathing volume of rat (0.38 m3/kg bw), 8h- breathing volume of human general population (6.7 m3) and 8 h- workers (10 m3). As no experimental data on absorption by inhalation is available, worst case assumption for absorption is applied: 50 % orally and 100 % by inhalation.
NAEC inh for worker = 200 mg/kg bw/d / (0.38 m3/kg bw) × (6.7 m3/10 m3 (8h)) × 0.5
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used for NAEC derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 d) to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling has been already considered in starting point derivation
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no significant uncertainties remaining
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
HAZARD VIA INHALATION ROUTE
Systemic effects long term exposure
No experimental evidence of absorption via inhalation is available, however a DNEL is computed mainly considering that the substance is a powder with MMD of 3.1 µm.
Absorption may occur via the respiratory tract as well as via the gastrointestinal tract if inhaled particles are swallowed.
For DNEL calculation, NOAEL from oral repeated dose toxicity study (28 days) in rats was selected as the most representative starting dose based on: study duration, presence of adverse effects, parameters observed.
Starting from an oral NOAEL, a corrected value is obtained considering: 8h- breathing volume of rat (0.38 m3/kg bw), 8h- breathing volume of human general population (6.7 m3) and 8 h- workers (10 m3). As no experimental data on absorption by inhalation is available, worst case assumption for absorption is applied: 50 % orally and 100 % by inhalation.
NAEC for worker = 200 mg/kg bw/d / (0.38 m3/kg bw) × (6.7 m3/10 m3(8h)) × 0.5 = 176.32 mg/m³
An overall assessment factor of 75 to be applied is calculated considering AF for dose response relationship 1 (NOAEL used for NAEC derivation), AF for difference in duration of exposure 6 (subacute (28 d) to chronic), AF for interspecies differences 1 (allometric scaling has been already considered in starting point derivation), AF for other interspecies differences 2.5 (toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)), AF for intraspecies differences 5 (workers), AF for quality of the whole database 1 (good quality of available data) and AF for remaining uncertainties 1 (no significant uncertainties remaining).
Therefore, DNEL is calculated: 176.32 mg/m³ / 75 = 2.35 mg/m3.
Systemic effects short term exposure
According to “ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health”, 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. Since the substance is not classified for acute toxicity, no DNEL derivation is necessary and no hazard is identified.
Local effects long and short term exposures
Since no inhalation test was performed, no local effect could be observed. However, since the substance is non irritant to eye, an effect on mucous is not expected and no hazard is idenfied.
HAZARD VIA DERMAL ROUTE
Systemic effects long and short term exposure
The substance is classified as Skin Sensitizer sub-category 1B according to the CLP Regulation (EC 1272/2008). According to “ECHA Guidance on Information Requirements and Chemical Safety Assessment Part E: Risk Characterisation” medium hazard is associated to the substance.
Local effects long and short term exposures
As no skin irritation was observed in short term studies (i.e. acute dermal toxicity and skin irritation/corrosion), local effects for dermal route during both short and long term exposure are not expected.
HAZARD TO THE EYE
As the available test showed that the substance is not irritant to eye, no hazard is identified.
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
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 86.96 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL from oral repeated dose toxicity study (28 days) in rats was selected as the most representative starting dose based on: study duration, presence of adverse effects, parameters observed.
Starting from an oral NOAEL, a corrected value is obtained considering: 24 h- breathing volume of rat (1.15 m3/kg bw) and 24 h- breathing volume of human general population (20 m3). As no experimental data on absorption by inhalation is available, worst case assumption for absorption is applied: 50 % orally and 100 % by inhalation.
NAEC inh for general public = 200 mg/kg bw/d / (1.15 m3/kg bw) × 0.5 = 86.96 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used for NAEC derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 d) to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling has been already considered in starting point derivation
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no significant uncertainties remaining
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
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
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No extrapolation is necessary as NOAEL from oral repeated dose toxicity study (28 days) in rats was selected as the most representative starting dose based on: study duration, presence of adverse effects, parameters observed.
- AF for dose response relationship:
- 1
- Justification:
- NOEL used for NAEC derivation
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 d) to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats were used in the available test
- AF for other interspecies differences:
- 2.5
- Justification:
- toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of available data
- AF for remaining uncertainties:
- 1
- Justification:
- no other 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
HAZARD VIA INHALATION ROUTE
Systemic effects long term exposure
No experimental evidence of absorption via inhalation is available, however a DNEL is computed mainly considering that the substance is a powder with MMD of 3.1 µm.
Absorption may occur via the respiratory tract as well as via the gastrointestinal tract if inhaled particles are swallowed.
For DNEL calculation, NOAEL from oral repeated dose toxicity study (28 days) in rats was selected as the most representative starting dose based on: study duration, presence of adverse effects, parameters observed.
Starting from an oral NOAEL, a corrected value is obtained considering: 24 h- breathing volume of rat (1.15 m3/kg bw) and 24 h- breathing volume of human general population (20 m3). As no experimental data on absorption by inhalation is available, worst case assumption for absorption is applied: 50 % orally and 100 % by inhalation.
NAEC inh for general public = 200 mg/kg bw/d / (1.15 m3/kg bw) × 0.5 = 86.96 mg/m3
An overall assessment factor of 150 to be applied is calculated considering AF for dose response relationship 1 (NOAEL used for NAEC derivation), AF for difference in duration of exposure 6 (subacute (28 d) to chronic), AF for interspecies differences 1 (allometric scaling has been already considered in starting point derivation), AF for other interspecies differences 2.5 (toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)), AF for intraspecies differences 10 (general population), AF for quality of the whole database 1 (good quality of available data) and AF for remaining uncertainties 1 (no significant uncertainties remaining).
Therefore, DNEL is calculated: 86.96 mg/m³ / 150 = 0.58.
Systemic effects short term exposure
According to “ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health”, 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. Since the substance is not classified for acute toxicity, no DNEL derivation is necessary andno hazard is identified.
Local effects long and short term exposures
Since no inhalation test was performed, no local effect could be observed. However, since the substance is non irritant to eye, an effect on mucous is not expected and no hazard is idenfied.
HAZARD VIA DERMAL ROUTE
Systemic effects long and short term exposures
The substance is classified as Skin Sensitizer sub-category 1B according to the CLP Regulation (EC 1272/2008). According to “ECHA Guidance on Information Requirements and Chemical Safety Assessment Part E: Risk Characterisation” medium hazard is associated to the substance.
Local effects long and short term exposures
As no skin irritation was observed in short term studies (i.e. acute dermal toxicity and skin irritation/corrosion), local effects for dermal route in long and short exposure are not expected.
HAZARD VIA ORAL ROUTE
Systemic effects long term exposure
For DNEL calculation, NOAEL from oral repeated dose toxicity study (28 days) in rats was selected as the most representative starting dose based on: study duration, presence of adverse effects, parameters observed.
An overall assessment factor of 600 to be applied is calculated considering AF for dose response relationship 1 (NOAEL used for NAEC derivation), AF for difference in duration of exposure 6 (subacute (28 d) to chronic), AF for interspecies differences 4 ( rats were used in the available test), AF for other interspecies differences 2.5 (toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)), AF for intraspecies differences 10 (general population), AF for quality of the whole database 1 (good quality of available data) and AF for remaining uncertainties 1 (no significant uncertainties remaining).
Therefore, DNEL is calculated: 200 mg/kg bw / 600 = 0.33.
Systemic effects short term exposure
According to “ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health”, 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. Since the substance is not classified for acute toxicity, no DNEL derivation is necessary.
HAZARD TO THE EYE
As the available test showed that the substance is not irritant to eye, no hazard is identified.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)