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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 259-134-5 | CAS number: 54381-16-7
- 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://chesar.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:
- 0.176 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 17.632 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC = NOAEL oral * (1/SRVrat) * (sRVhuman/wRV)*(ABS oral-rat /ABS inh-human) = 5*1/0.38*0.67*0.5 = 4.407 mg/m3
sRV human = standard respiratory volume human= 6.7 m3 (8h)
wRV = worker respiratory volume =10 m3 (8h)
sRVrat = standard respiratory volume rat = 0.38 m3/kg/d
ABS = Absorption
Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- expert judgement
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value systemic effect
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on respiratory tract
- AF for intraspecies differences:
- 5
- Justification:
- default value worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 69.444 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 6 944.44 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL was set at 5 mg/kg bw/day (14 day range-finding study) and at 20 mg/kg bw/day (90 day study). The maternal NOAEL was 5 mg/kg/day; the developmental NOAEL was 50 mg/kg/day. The NOAEL from maternal toxicity had been used for the calculation of margin of
safety by SCCS, and is the same value conisdered for DNEL calculation.
Absorption oral versus dermal are calculated, taking into account the dermal penetration rate of 0.072% . Oral absorption is assumed to be 100%
NOAEL dermal = 5 mg/kg bw/d x (100/0.072) = 6944.44 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- expert judgement
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric value (rat)
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on respiratory tract
- AF for intraspecies differences:
- 5
- Justification:
- default value worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.33 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- other: EC3
- Value:
- 260 µg/m³
- AF for dose response relationship:
- 3
- Justification:
- the EC3 is considered as a LOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- default value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value - local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1)
- AF for other interspecies differences:
- 1
- Justification:
- default value. In terms of dynamics, one might assume that animals and humans will respond to the insult in the same way. In this case, the default
factor for remaining uncertainties of 2.5 could be reduced to 1 - AF for intraspecies differences:
- 5
- Justification:
- default value for worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.33 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- other: EC3
- Value:
- 260 µg/m³
- AF for dose response relationship:
- 3
- Justification:
- the EC3 is considered as a LOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value - local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1)
- AF for other interspecies differences:
- 1
- Justification:
- default value. In terms of dynamics, one might assume that animals and humans will respond to the insult in the same way. In this case, the default factor for remaining uncertainties of 2.5 could be reduced to 1
- AF for intraspecies differences:
- 5
- Justification:
- default value for worker
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.055 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2.74 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL was set at 5 mg/kg bw/day (14 day range-finding study) and at 20 mg/kg bw/day (90 day study). The maternal NOAEL was 5 mg/kg/day; the developmental NOAEL was 50 mg/kg/day. The NOAEL from maternal toxicity had been used for the calculation of margin of safety by SCCS, and is the same value conisdered for DNEL calculation.
NOAEC (dose descriptor calculation).
NOAEL oral * (1/SRVrat) * (ABS oral-rat/ABS inh-human)= NOAEL oral*1/1.15*(50/100) = 5*1/1.15*0.5= 2.174 mg/m3
Oral rat default absorption rate: 100% (50% if oral-to-inhalation extrapolation)
Inhalation human default absorption rate : 100%
sRVrat = standard respiratory volume rat = 1.15 m3/kg/d
ABS = Absorption
Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- expert judgement
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value systemic effect
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect
- AF for intraspecies differences:
- 10
- Justification:
- default value general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 138.88 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 944.44 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL was set at 5 mg/kg bw/day (14 day range-finding study) and at 20 mg/kg bw/day (90 day study). The maternal NOAEL was 5 mg/kg/day; the developmental NOAEL was 50 mg/kg/day. The NOAEL from maternal toxicity had been used for the calculation of margin of safety by SCCS, and is the same value conisdered for DNEL calculation.
Absorption oral versus dermal are calculated, taking into account the dermal penetration rate of 0.072% . Oral absorption is assumed to be 100%
NOAEL dermal = 5 mg/kg bw/d x (100/0.072) = 6944.44 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- expert judgement
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect
- AF for intraspecies differences:
- 10
- Justification:
- default value general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.666 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- other: EC3
- Value:
- 260 µg/m³
- AF for dose response relationship:
- 3
- Justification:
- EC 3 is considered as LOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- default value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value - local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1)
- AF for other interspecies differences:
- 1
- Justification:
- default value. In terms of dynamics, one might assume that animals and humans will respond to the insult in the same way. In this case, the default factor for remaining uncertainties of 2.5 could be reduced to 1
- AF for intraspecies differences:
- 10
- Justification:
- default value genearl population
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.666 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor starting point:
- other: EC3
- Value:
- 260 µg/m³
- AF for dose response relationship:
- 3
- Justification:
- EC 3 is considered as LOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default value - local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1)
- AF for other interspecies differences:
- 1
- Justification:
- default value. In terms of dynamics, one might assume that animals and humans will respond to the insult in the same way. In this case, the default factor for remaining uncertainties of 2.5 could be reduced to 1
- AF for intraspecies differences:
- 10
- Justification:
- default value genearl population
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 2
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.025 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 2
- Justification:
- expert judgement
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect
- AF for intraspecies differences:
- 10
- Justification:
- default value genearl population
- AF for the quality of the whole database:
- 1
- Justification:
- reliability 1
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 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):
- 50
- Dose descriptor starting point:
- other: DL0
- Value:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is also not appropriate for acute lethal effects as these effects, which are accomplished by an immediate and intolerable level of damage to some critical homeostatic processes, may be independent of caloric demand and related physiological processes which affect toxicity
- AF for other interspecies differences:
- 2.5
- Justification:
- default value systemic effect
- AF for intraspecies differences:
- 10
- Justification:
- default value general population
- AF for the quality of the whole database:
- 2
- Justification:
- expert judgment.
- AF for remaining uncertainties:
- 1
- Justification:
- not concerned
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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.
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