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EC number: 931-324-9 | CAS number: 866889-72-7
- 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
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:
- 3.53 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:
- 88.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No data available on inhalation route; therefore DNEL should be derived from an oral route study.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for other interspecies differences:
- 2.5
- Justification:
- Rat to human
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No data available on dermal route; therefore DNEL should be derived from an oral route study.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Rat to human
- AF for intraspecies differences:
- 5
- Justification:
- Worker
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 6 % in mixture (weight basis)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 6 % in mixture (weight basis)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 5
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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:
- 0.87 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:
- 43.48 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No data available on inhalation route; therefore DNEL should be derived from an oral route study.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for other interspecies differences:
- 2.5
- Justification:
- Rat to human
- AF for intraspecies differences:
- 10
- Justification:
- Consumer
- AF for the quality of the whole database:
- 1
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No data available on dermal route; therefore DNEL should be derived from an oral route study.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Rat to human
- AF for intraspecies differences:
- 10
- Justification:
- Consumer
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 3 % in mixture (weight basis)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 3 % in mixture (weight basis)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 10
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Rat to human
- AF for intraspecies differences:
- 10
- Justification:
- Consumer
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
A.- ACUTE TOXICITY. Systemic effects
Acute exposure is assessed when there is possibility of pick exposure. No pick exposures are likely to occur with this substance. Furthermore, assessment of long term exposure would cover acute exposures.
B.- IRRITATION/ CORROSION
The substance shows irritancy capability when tested at 92%. However when tested at 30% and 5% is not irritant. Therefore this concentration can be defined as the NOAEL. No inter-species AF is to be applied. For intra-species, an AF of 5 is applied for workers and 10 for consumers.
Therefore the threshold is assumed to be 6% for workers and 3% for consumers (18,2% and 9% respectively for 33% preparation).
Insufficient information was available from the eye irritation test to determine a dose-relationship or a dose dependency for any irritant or corrosive effects.
C.- SENSITIZATION
The substance does not exhibited experimental evidence of sensitizing potential.
D.- MUTAGENICITY/ CARCINOGENICITY
There were no indications of a possible non-threshold mutagenic or tumorigenic response by any exposure route and the experimental results show no positive responses for in vitro/ in vivo mutagenicity assays. Therefore DNELs have not been established either for carcinogenicity nor mutagenicity.
E.- REPEAT DOSE TOXICITY: Systemic effects
Starting point for long-term DNELs derivation is a 90 days repeat dose toxicity study in rats. Duration differencesis set in the REACH guidance as AF = 2 (the assessment factor for extrapolation from subchronic to chronic exposure)
Dose-response related issues
Since the DNEL is to be derived from a from a good quality study, the dose response assessment factor was the default value, AF = 1.
Quality of whole database
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgement related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Dermal exposure
Since no dose descriptor was available from a repeated application dermal toxicity study and dermal exposure is the most probable route of human exposure, it was necessary to derive a corrected dermal NOAEL from the oral NOAEL. The oral dose descriptor was used as the basis for route-to-route extrapolation.
Dermal risk assessment is based on the oral NOAEL of 50 mg/kg/day from the 90 day rat study.
It is commonly assumed that dermal absorption will not exceed oral absorption. However worst case scenario would assume to be 100% dermal absorption.
The following adjustment factors are applied for the identification of the reference DNEL:
(1) for duration adjustment a factor of 2 is used
(2) the allometric scaling factor for the rat is 4;
(3) a default factor of 2.5 accounts for additional interspecies differences;
(4) for intraspecies differences the default factor is 5 for workers and for consumers is 10
Applying these factors to the oral NOAEL:
DNEL dermal, systemic, chronic worker = 50/100 = 0.5 mg/kg bw/day, (1.515 mg/kg bw/day for 33% preparation)
DNEL dermal, systemic, chronic consumers= 50/200 =0.25mg/kg bw/day (0.75 mg/kg bw/day for 33% preparation)
Oral exposure
Starting point is NOAEL of 50 mg/kg/day from a 90 days rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:
DNEL oral, systemic, chronic general population = 50/200= 0.25 mg/kg/day (0.75 mg/kg bw/day for 33% preparation)
No oral exposure is considered for workers.
Inhalatory exposure
For the chronic inhalation exposure DNELs, the corrected NOAEL was derived as a starting point based on the oral NOAEL of 50 mg/kg bw/day, since no study data were available from long term repeated exposure investigations via the inhalation route. This route is considered of minor concern due to the vapour pressure of the substance.
The total assessment factor for the worker population, long term DNEL inhalation, systemic = 2.5*5*2*1*1 = 25 when the subchronic to chronic factor is included.
The total assessment factor for the general population, long term DNEL inhalation, systemic = 2.5*10*2*1*1 = 50 when the factor for subchronic to chronic exposure is included.
Differences in respiration volumes were assessed for converting the oral dose to an inhalation concentration:
Worker Population - NOAEL of 50 mg/kg/d /0.38m3/kg = 131.6 * [6.7 m3/ 10 m3] = 88.16 mg/m3.
General Population - NOAEL of 50 mg/kg/d /1.15m3/kg = 43.48 mg/m3,
Applying the above explained AF:
DNEL inhalation, systemic, chronic worker population = 88.16 / 25 = 3.53 mg/m3 (10.7 mg/m3 for 33% preparation)
DNEL inhalation, systemic, chronic general population = 43.48 / 50 = 0.87 mg/m3 (2.67 mg/m3 for 33% preparation)
The default absorption percentage 100%, for inhalation has also been used in the calculations.
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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