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Diss Factsheets
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EC number: 211-199-0 | CAS number: 633-96-5
- 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:
- 0.176 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.41 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC worker (8h) = (2.5 mg/kg bw/0.38 m³/kg bw) * 6.7 m³/ 10 m³ [where: NAEC is the modified starting point; 2.5 mg/kg bw is the NOAEL for repeated toxicity, based on the substance purity (Colipa num 15, SCCS/1382/10); 0.38 m³/kg bw is the default respiratory volume for the rat corresponding to the daily duration of human exposure; for workers a further correction is needed for the difference between respiratory rates under standard conditions and under conditions of light activity. This correction factor derives from the inhalation volumes in 8 hours under the respective conditions (6.7 m3 for base level, 10 m3 for light activity)]
- AF for dose response relationship:
- 1
- Justification:
- data well supported
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Scaling issues just evaluated in modified starting poi
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- worker factor
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- Good quality and reliability
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
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.025 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long-term DNEL for dermal route calculation (systemic effects, route to-route extrapolation) = 2.5 mg/kg bw is the NOAEL for repeated dose toxicity oral route / 100 = 0.025 mg/kg bw; AF workers = 4 (rat to human)*5 (workers)*2(subchronic to chronic) * 2.5 = 100
- AF for dose response relationship:
- 1
- Justification:
- data well supported
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- From rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- Good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not classified for acute toxicity hazards for this reason no acute DNEL(S) need to be calculated
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
The
Derived No Effect Levels for inhalation and dermal long-term exposure
are estimated from the No Observed Effect Level obtained from the
reproductive toxicity assessment.
In general, the calculations of DNELs is based on the observed effect
level and have to be corrected for the differences between effect
assessment data and the real human exposure situation, taking into
account variability and uncertainty within and between species. In order
to correct the interspecies difference between rat and human the no
observed effect level has to be corrected as mentioned below.
SYSTEMIC
EFFECTS LONG TERM EXPOSURE - INHALATION ROUTE
NAEC
worker (8h) = (2.5 mg/kg bw/0.38 m³/kg bw) * 6.7 m³/ 10 m³ [where: NAEC
is the modified starting point; 2.5 mg/kg bw is the NOAEL for repeated
dose toxicity (oral route); 0.38 m³/kg bw is the default respiratory
volume for the rat corresponding to the daily duration of human
exposure. For workers a further correction is needed for the difference
between respiratory rates under standard conditions and under conditions
of light activity. This correction factor derives from the inhalation
volumes in 8 hours under the respective conditions (6.7 m³ for base
level, 10 m³/kg for light activity)].
Thus, the
corrected starting point NAEC was estimated to be 4.41 mg/m³.
Subsequently other assessment factors have been used to derived the DNEL:
- differences in duration of exposure 2, because the starting value
resulted from a subchronic study
- remaining differences 2.5
- intraspecies differences 5, for worker population
The overall assessment factor (AF) is equal to: 2* 2.5 * 5 = 25
DNEL is therefore obtained as followed: DNEL = NAEC / AF (overall
assessment factor) = 2.5 mg/ m3 / 25 = 0.17 mg/m3
SYSTEMIC EFFECTS LONG TERM EXPOSURE - DERMAL ROUTE
The following assessment factors have been used to derived the DNEL:
- differences in duration of exposure 2, because the starting value resulted from a subchronic study
- for interspecies differences the allometric scaling of 4 has been used because the NOAEL was recorded in a study conducted on rats
- remaining differences 2.5
- intraspecies differences 5, for worker population.
The overall assessment factor (AF) is equal to: 2 * 4* 2.5 * 5 = 100
DNEL is therefore obtained as followed: DNEL = NOAEL / AF (overall assessment factor) = 2.5 mg/kg bw/day / 100 = 0.025 mg/kg bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.043 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):
- 200
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2.174 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL/1.15 (sRV for 24h rat)
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- Good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- 0.02 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL = 4/ 200 (AF) = 0.02. The most sensitive available end point is the repeated dose toxicity dermal for which DNEL is derived.
- AF for dose response relationship:
- 1
- Justification:
- data well suported
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- Good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- 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:
- 0.013 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:
- 2.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No default factor should be introduced when performing on the same route Long-term DNEL for oral route calculation (systemic effects, route to-route extrapolation) = 2.5 / 4*2.5*10 (b) *2 (c) = 0.125 mg/kg bw/day (b) assessment factors (interspecies * intraspecies (4*2.5) * 10) (c) Correction for duration from subchronic to chronic (6)
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality and reliability
- AF for remaining uncertainties:
- 1
- Justification:
- Good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The
Derived No Effect Levels for oral, inhalation and dermal long-term
exposure are estimated from the No Observed Effect Level obtained from
the repeated dose toxicity assessment.
In general, the calculations of DNELs is based on the observed effect
level and have to be corrected for the differences between effect
assessment data and the real human exposure situation, taking into
account variability and uncertainty within and between species. In order
to correct the interspecies difference between rat and human the no
observed effect level has to be corrected as mentioned below.
GENERAL POPULATION: SYSTEMIC EFFECTS LONG TERM EXPOSURE - INHALATION
ROUTE
NAEC general population = (NOAEL oral-rat / sRV rat general
population)
NOAEL oral
– rat = 2.5 mg/kg bw
sRV (standard respiratory volume) general population: rat 24 h exposure
(m3/kb bw) = 1.15
Thus, the
corrected starting point NAEC was estimated to be 2.17 mg/m³.
Subsequently other assessment factors have been used to derived the DNEL:
- differences in duration of exposure 2, because the starting value
resulted from a subchronic study
- for interspecies differences the allometric scaling of 4 has been used
because the NOAEL was recorded in a study conducted on rats
- remaining differences 2.5
- intraspecies differences 10, for general population
The overall assessment factor (AF) is equal to: 2 * 4 * 2.5 * 10 = 200
DNEL is therefore obtained as followed: DNEL = NAEC / AF (overall
assessment factor) = 0.04348 mg/m3
GENERAL
POPULATION: SYSTEMIC EFFECTS LONG TERM EXPOSURE - DERMAL ROUTE
The
following assessment factors have been used to derived the DNEL:
- differences in duration of exposure 2, because the starting value
resulted from a subchronic study
- for interspecies differences the allometric scaling of 4 has been used
because the NOAEL was recorded in a study conducted on rats
- remaining differences 2.5
- intraspecies differences 10, for general population.
The overall assessment factor (AF) is equal to: 2 * 4* 2.5 * 10 = 200
DNEL is therefore obtained as followed: DNEL = NOAEL / AF (overall
assessment factor) = 4 mg/kg bw/day / 200 = 0.025 mg/kg bw/day
GENERAL
POPULATION: SYSTEMIC EFFECTS LONG TERM EXPOSURE - ORAL ROUTE
The
following assessment factors have been used to derived the DNEL:
- differences in duration of exposure 2, because the starting value
resulted from a subchronic study
- for interspecies differences the allometric scaling of 4 has been used
because the NOAEL was recorded in a study conducted on rats
- remaining differences 2.5
- intraspecies differences 10, for general population.
The overall assessment factor (AF) is equal to: 2 * 4* 2.5 * 10 = 200
DNEL is therefore obtained as followed: DNEL = NOAEL / AF (overall
assessment factor) = 2.5 mg/kg bw/day / 200 = 0.0125 mg/kg bw/day
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