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Diss Factsheets
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EC number: - | 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:
- 23.51 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Relevant inhalation study is not available
- AF for dose response relationship:
- 1
- Justification:
- adequate data available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- covered in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for a further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for a further assessment factor
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:
- 3.33 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Relevant study via dermal application is not available
- AF for dose response relationship:
- 1
- Justification:
- adequate data available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for a further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for a further assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute/short term exposure (systemic and local effects):
- No data are available for acute toxicity via the inhalation route. A key study is available for the oral route of exposure and for the dermal route of exposure. According to the REACH Regulation, only one additional route of exposure other than the oral route of exposure should be tested for acute toxicity (column 2, annex VIII, section 8.5). Therefore it is not necessary to perform an acute toxicity study via the inhalation route of exposure.
- An acute dermal toxicity study has been performed in rats. The LD50 was determined to be > 2000 mg/kg (based on active ingredient). Therefore the substance is not classified based on CLP Regulation. As no peak exposure is anticipated for this substance, it is considered that the long-term DNEL is sufficiently protective for acute exposure.
- According to the criteria of the CLP Regulation, the substance is classified as skin sensitizing (category 1B, H317). According to ECHA’s Guidance on Information Requirements and Chemical Safety Assessment, part E, Table E.3-1 the substance should be considered to cause moderate hazard.
Long-term exposure (systemic effects):
- Dermal: No long-term dermal toxicity studies are available for the substance. An oral combined repeated dose toxicity study with reproduction/developmental toxicity screening (OECD 422) with the substance could be used after extrapolation to the dermal route. Exposures were daily via oral gavage during 42 days (females) and 43 or 44 days for males (Rashid, 2015). Wistar rats (12 per sex and per dose) were treated at dose levels of 100, 300 and 1000 mg/kg/day (active ingredient). A control group of 12 males and 12 females received concurrent vehicle treatment. The NOAEL was considered to be the high dose of 1000 mg/kg/day. For route-to-route extrapolation (oral to dermal) no factor needs to be applied as it is assumed that oral and dermal absorption will be similar (assumed to be 50%). The dose descriptor starting point is 1000 mg/kg/day. The long-term dermal systemic DNEL is derived with an overall assessment factor of 300 : 4 (allometric scaling) x 2.5 (interspecies differences) x 6 (difference in duration subacute to chronic) x 5 (intraspecies differences). A long-term systemic DNEL of 1000 mg/kg/day/300 = 3.33 mg/kg/day is derived.
- Inhalation: the NOAEL observed in the combined repeated dose toxicity study with reproduction/developmental screening toxicity with the substance was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 1000 mg/kg/day x 1/(0.38 m3/kg/day) x 6.7 m3/10m3 = 1763.16 mg/m3. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m3/kg for 8 hours exposure for workers). For workers the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under the respective conditions (6.7 m3for base level, 10 m3for light activity). The bioavailability via the inhalation route is considered to be similar to bioavailability after oral exposure, i.e. 50%. With an overall assessment factor of 75: 6 (difference in duration subacute to chronic) x 5 (intraspecies differences) x 2.5 (interspecies – remaining differences), the long-term DNEL, inhalation for systemic effects of 1763.16 mg/m3/75 = 23.51 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.54 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 230 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Relevant inhalation study is not available
- AF for dose response relationship:
- 1
- Justification:
- adequate data available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for further assessment factor
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:
- 1.67 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Relevant study via dermal application is not available
- AF for dose response relationship:
- 1
- Justification:
- adequate data available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for further assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route extrapolation required
- AF for dose response relationship:
- 1
- Justification:
- adequate data available
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for further assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Acute/short-term exposure (systemic and local effects):
- An acute oral toxicity test has been performed in rats. The LD50 was >1000 mg/kg (active ingredient) and > 2000 mg/kg (test item). According to the criteria of the CLP regulation, the substance is not to be classified. As no peak exposure is anticipated for this substance, it is considered that the long-term DNEL is sufficiently protective for acute exposure.
- An acute dermal toxicity test has been performed in rats. The LD50 was > 2000 mg/kg (active ingredient). According to the criteria of the CLP Regulation, the substance is not to be classified via dermal application. As no peak exposure is anticipated for this substance, it is considered that the long-term DNEL is sufficiently protective for acute exposure.
- No data are available for acute toxicity via the inhalation route. A key study is available for the oral route of exposure and for the dermal route of exposure. According to the REACH Regulation, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (column 2, annex VIII, section 8.5). Therefore, it is not necessary to perform an acute toxicity study via the inhalation route of exposure.
- According to the criteria of the CLP Regulation, the substance is classified as skin sensitizing (category 1B, H317). According to ECHA’s Guidance on Information Requirements and Chemical Safety Assessment, part E, Table E.3-1 the substance should be considered to cause moderate hazard.
Long-term exposure (systemic effects)
- Inhalation:The NOAEL observed in the combined repeated dose toxicity study with reproduction/developmental toxicity screening with the substance was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 1000 mg/kg bw/day x 1/(1.15 m³/kg/day)= 230 mg/m³.The dermal dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m³/kg for 24 hours exposure).The bioavailability via the inhalation route is considered 50%, similar to that after oral exposure No correction for the exposure duration was added as the animals in the reference study were exposed daily. With an overall assessment factor of 150: 6 (difference in duration subacute to chronic) x 10 (intraspecies differences) x 2.5 (interspecies - remaining differences), the long-term DNEL inhalation for systemic effects of 230 mg/m³/150 = 1.54 mg/m³ is derived.
- Dermal: The long-term systemic DNEL for the dermal route was derived based on the combined repeated dose toxicity study with reproduction/developmental toxicity screening with the substance. No correction for the exposure duration was added as the animals in the reference study were exposed daily. The dose descriptor starting point = 1000 mg/kg/day. The NOAEL does not needed to be multiplied by a factor as the bioavailability via the dermal route is considered 50%, similar to the oral bioavailability (50%). With an overall assessment factor of 600: 6 (difference in duration subacute to chronic) x 4 (interspecies differences allometric scaling) x 2.5 (remaining differences) x 10 (intraspecies differences), the long-term DNEL, dermal for systemic effects of 1000 mg/kg/day/600 = 1.67 mg/kg/day is derived.
- Oral: The long-term systemic DNEL for the oral route was derived based on the combined repeated dose toxicity study with reproduction/developmental toxicity screening with the substance. No correction for the exposure duration was added as animals in the reference study were dosed daily, so the dose descriptor starting point = 1000 mg/kg/day. The long-term oral systemic DNEL is derived with an overall assessment factor of 600: 4 (allometric scaling) x 2.5 (remaining interspecies differences) x 6 (difference in duration subchronic to chronic) x 10 (intraspecies differences). A long-term systemic DNEL of 1000 mg/kg/day/600 = 1.67 mg/kg/day is derived.
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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