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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 909-125-3 | 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:
- 166.67 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 000 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No information form long term inhalation study available
- AF for dose response relationship:
- 1
- Justification:
- AF according to ECETOC report
- AF for differences in duration of exposure:
- 2
- Justification:
- Exposure duration (sub chronic to chronic) 2 AF according to ECETOC report
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already in starting point correction
- AF for other interspecies differences:
- 1
- Justification:
- AF according to ECETOC report
- AF for intraspecies differences:
- 3
- Justification:
- Intraspecies (worker) 3 AF according to ECETOC report
- AF for the quality of the whole database:
- 1
- Justification:
- AF according to ECETOC report
- AF for remaining uncertainties:
- 1
- Justification:
- AF according to ECETOC report
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 23.81 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report
- Overall assessment factor (AF):
- 8.4
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
worst case assumption (not necessary correct) NOAEL oral -> NOAEL dermal = NOAEL oral x 1(Echa assumption)
- AF for dose response relationship:
- 1
- Justification:
- AF according to ECETOC report
- AF for differences in duration of exposure:
- 2
- Justification:
- Exposure duration (sub chronic to chronic) 2
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- Interspecies (AS, dog) 1.4
- AF for other interspecies differences:
- 1
- Justification:
- AF according to ECETOC report
- AF for intraspecies differences:
- 3
- Justification:
- Intraspecies (worker) 3 AF according to ECETOC report
- AF for the quality of the whole database:
- 1
- Justification:
- AF according to ECETOC report
- AF for remaining uncertainties:
- 1
- Justification:
- AF according to ECETOC report
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Only long term exposure values for worker and general population were calculated, because no concrete values (like NOAEL, LOAEL etc) are available from acute or irritation studies. The study designs of the tests conducted assessing the acute and local toxicity do
in general not allow the derivation of local or acute DNEL, as most of the test were, for example, conducted as limit tests due to animal welfare.
For long term effects a valid repeated dose animal studies is available to derive DNEL values.
In a 90-day gavage study (Bayer 2000, J. Ruf) beagle dogs were treated once daily with the registered substance.
The NOEL at 40 mg/kg bw/d (0.4%) reported in this study is based on local effects caused by oral application of the test substance at irritating concentrations (≥2%). At 200 mg/kg bw/d clinical chemistry revealed only slightly increased liver findings (weight increase, N-DEM and CYP-450 increase) but this should not be regarded as adverse effects but as increased metabolic activity of the organ (adaptive response). Therefore the NOAEL is established at 200 mg/kg bw/d.
The 90-day dog study is considered the most appropriate study for a DNEL derivation as dogs were found to be the most sensitive species based on clinical findings at 500 mg/kg bw/d.
Therefore the following values were used to derive DNELs: Dog subchronic (13 weeks; gavage) NOAEL (systemic) = 200mg/kg bw/d; NOEL (local) = 40mg/kg bw/d
As local dermal or inhalation effects can not be evaluated from local oral effects the DNEL values for local effects were not derived.
However, a qualitative risk assessment has been carried out.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 500 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No information form long term inhalation study available
- AF for dose response relationship:
- 1
- Justification:
- AF according to ECETOC report
- AF for differences in duration of exposure:
- 2
- Justification:
- Exposure duration (sub chronic to chronic) 2
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies (AS, dog) (already in starting point mod.)
- AF for other interspecies differences:
- 1
- Justification:
- AF according to ECETOC report
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies (general pop) AF = 5 according to ECETOC report
- AF for the quality of the whole database:
- 1
- Justification:
- AF according to ECETOC report
- AF for remaining uncertainties:
- 1
- Justification:
- AF according to ECETOC report
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 14.29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
worst case assumption (not necessary correct) NOAEL oral -> NOAEL dermal = NOAEL oral x 1(Echa assumption)
- AF for dose response relationship:
- 1
- Justification:
- AF according to ECETOC report
- AF for differences in duration of exposure:
- 2
- Justification:
- Exposure duration (sub chronic to chronic) 2
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- Interspecies (AS, dog) 1.4
- AF for other interspecies differences:
- 1
- Justification:
- AF according to ECETOC report
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies (general pop) AF = 5 according to ECETOC report
- AF for the quality of the whole database:
- 1
- Justification:
- AF according to ECETOC report
- AF for remaining uncertainties:
- 1
- Justification:
- AF according to ECETOC report
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
no starting point correction
- AF for dose response relationship:
- 1
- Justification:
- AF according to ECETOC report
- AF for differences in duration of exposure:
- 2
- Justification:
- Exposure duration (sub chronic to chronic) 2
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- Interspecies (AS, dog) 1.4
- AF for other interspecies differences:
- 1
- Justification:
- AF according to ECETOC report
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies (general pop) AF = 5 according to ECETOC report
- AF for the quality of the whole database:
- 1
- Justification:
- AF according to ECETOC report
- AF for remaining uncertainties:
- 1
- Justification:
- AF according to ECETOC report
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Only long term exposure values for worker and general population were calculated, because no concrete values (like NOAEL, LOAEL etc) are available from acute or irritation studies. The study designs of the tests conducted assessing the acute and local toxicity do
in general not allow the derivation of local or acute DNEL, as most of the test were, for example, conducted as limit tests due to animal welfare.
For long term effects a valid repeated dose animal studies is available to derive DNEL values.
In a 90-day gavage study (Bayer 2000, J. Ruf) beagle dogs were treated once daily with the registered substance.
The NOEL at 40 mg/kg bw/d (0.4%) reported in this study is based on local effects caused by oral application of the test substance at irritating concentrations (≥2%). At 200 mg/kg bw/d clinical chemistry revealed only slightly increased liver findings (weight increase, N-DEM and CYP-450 increase) but this should not be regarded as adverse effects but as increased metabolic activity of the organ (adaptive response). Therefore the NOAEL is established at 200 mg/kg bw/d.
The 90-day dog study is considered the most appropriate study for a DNEL derivation as dogs were found to be the most sensitive species based on clinical findings at 500 mg/kg bw/d.
Therefore the following values were used to derive DNELs: Dog subchronic (13 weeks; gavage) NOAEL (systemic) = 200mg/kg bw/d; NOEL (local) = 40mg/kg bw/d
As local dermal or inhalation effects can not be evaluated from local oral effects the DNEL values for local effects were not derived.
However, a qualitative risk assessment has been carried out.
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.
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