Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 227-290-3 | CAS number: 5766-67-6
- 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:
- 4.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 220 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- systemic effects present in 6-wk oral study
- AF for dose response relationship:
- 1
- Justification:
- NOAEL availabale
- AF for differences in duration of exposure:
- 4
- Justification:
- from 6-week to subchronic (2) and from subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already in sRV
- AF for other interspecies differences:
- 2.5
- Justification:
- systemic effects
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- well performed study available
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.75 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- systemic effects present in 6-wk oral study
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 4
- Justification:
- from 6-week to subchronic (2) and from subchronic to chronic (2)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- systemic effects
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- well performed study
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
This dossier is a registration of a well contained transported isolated intermediate. As such exposure is not likely. However, because toxicity data are available on repeated exposure, DNELs for worker exposure (long term, systemic, inhalation and dermal) have been calculated.
Dermal Worker-DNEL-long-term systemic
There is no data available on systemic toxicity following repeated dermal exposures. However, a DNEL for dermal route can be derived by route-to-route extrapolation from an oral NOAEL of 250 mg/kg bw/day from a 6 -week study in rat. Since it is generally accepted that substances with log Pow ranging from 0.1 to 6 penetrate the skin easily, it is to be expected that EDTN will not penetrate the skin to a large extent. As such it is expected that
dermal absorption will be lower than oral absorption, a conservative factor of 1/3 was used for oral-to-dermal extrapolation.Thus calculated: dermal absorption is 1; oral absorption 3. Corrected dermal NOAEL = oral NOAEL x [absorption (oral-rat) / absorption (dermal-human)]. This will be: 250 x 3/1 = 750 mg/kg
Assessment factors:
- Interspecies (allometric scaling): 4
- Interspecies (remaining differences): 2.5 (systemic effects)
- Intraspecies for workers: 5
- Exposure duration 6 -week to subchronic (2) and from subchronic to chronic (2): 4
This results in a total assessment factor of 200, indicating a DNEL of 750/200 = 3.75 mg/kg bw/day.
Inhalation Worker-DNEL-long-term systemic
There is no data available on systemic toxicity following repeated inhalation exposures. However, a DNEL for the inhalation route can be derived by route-to-route extrapolation from an oral NOAEL of 250 mg/kg bw/day from a 6 -week study in rat.
- Corrected inhalatory NOAEC = oral NOAEL x (1/sRVrat)x(ABSoral-rat/ABSinh-human)x(sRVhuman/wRV) =
250 mg/kg bw/day x (1/0.38m3) x (1/2) x (6.7m3/10m3 = 220 mg/m3
ABS: Absorption; sRV: standard Respiratory Volume; wRV: worker Respiratory Volume
- Interspecies (allometric scaling): 1 (not needed, already in sRV)
- Interspecies (remaining differences): 2.5 (systemic effects)- Intraspecies for workers: 5
- Exposure duration 6 -week to subchronic (2) and from subchronic to chronic (2): 4
This results in a total assessment factor of 50, indicating a DNEL of 220/50 = 4.4 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.