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Diss Factsheets
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EC number: 682-238-0 | CAS number: 1190931-27-1
- 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:
- 35 µg/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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL derivation was done according to the ECHA guidance R.8 using the rat oral 90-day NOAEL as starting point and route-to-route extrapolation.
Corrected inhalatory NOAEC = Oral NOAEL x 1 / sRVrat x Abs (oral, rat) / Abs (inhal, human) x sRVhuman / wRV
In the absence of substance-specific information the default values were used for the route-to-route extrapolation, i.e. 100% absorption by inhalation and 50% by oral route according to the R.8 Guidance document.
- AF for dose response relationship:
- 1
- Justification:
- No dose-response relationship issue identified
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value for subchronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Route-to route-extrapolation performed
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for other TK differences
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Database of appropriate quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainty identified
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:
- 10 µg/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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In the absence of specific study by the dermal route, the DNEL for long-term systemic effects by the dermal route was derived using the rat oral 90-day NOAEL as a starting point.
Dermal NOAEL = Oral NOAEL x Abs (oral, rat) / Abs (dermal, human)
For the route-to route-extrapolation, in the absence of substance-specific data, in a worst-case approach, both oral absorption in rats and dermal absorption in humans were considered to be 100%.- AF for dose response relationship:
- 1
- Justification:
- No dose-response relationship issue identified
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value for subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for other TK differences
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Database of appropriate quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainty identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
Two DNEL values for industrial workers were derived for systemic effects after long-term exposure: a dermal DNEL and an inhalation DNEL. Both values were based on the rat NOAEL determined in the 90-day repeated toxicity study: 1 mg/kg bw/day. As this NOAEL was observed in an oral study, a route-to-route extrapolation was needed in order to obtain the correct starting points for the derivation of the DNEL. The correct starting points were than divided by an overall assessment factor, which was a result of various consideration on uncertainties in inter-and intra-species variations, and on differences in the duration of exposure between test animals and humans. Moreover also the whole quality of the database was considered.
For acute dermal local effects, no DNEL could be derived, as the key study used to evaluate this endpoint was an in vitro study which provided only qualitative data. The acute dermal toxicity study was used, in this case, as supporting the evidence of the irritation potential of the substance.
For acute dermal systemic effects, the derivation of a DNEL was not considered appropriate because no specific systemic hazard has been identified for acute dermal exposure and no peak exposure is expected to occur.
Moreover the DNELs derived for the long-term exposure are considered conservative enough to protect also from acute exposure effects.
Local effects after repeated dermal exposure were evaluated from a qualitative point of view, considering the irritation potential of the substance and the negative results of the sensitization tests.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9 µg/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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Corrected inhalatory NOAEC = Oral NOAEL x 1 / sRVrat x Abs (oral, rat) / Abs (inhal, human)
- AF for dose response relationship:
- 1
- Justification:
- No dose-response relationship issue identified
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value for subchronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Route-to route-extrapolation performed
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for other TK differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Database of appropriate quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainty identified
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:
- 5 µg/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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In the absence of specific study by the dermal route, the DNEL for long-term systemic effects by the dermal route was derived using the rat oral 90-day NOAEL as a starting point and route-to-route extrapolation. The DNEL derivation was done according to the ECHA guidance R.8.
Dermal NOAEL = Oral NOAEL x Abs (oral, rat) / Abs (dermal, human)
For the route-to route-extrapolation, in the absence of substance-specific data, in a worst-case approach, both oral absorption in rats and dermal absorption in humans were considered to be 100%. No modification of the dose descriptor starting point is necessary.- AF for dose response relationship:
- 1
- Justification:
- No dose-response relationship issue identified
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value for subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for other TK differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Database of appropriate quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainty identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 µg/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):
- 1 000
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- (Default)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default value for subchronic study (NOAEL from a 90-day study)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- (Default)
- AF for other interspecies differences:
- 2.5
- Justification:
- (Default)
- AF for intraspecies differences:
- 10
- Justification:
- (Default)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value. Information in addition to standard requirements was available in the dataset.
- AF for remaining uncertainties:
- 5
- Justification:
- An additional assessment factor of 5 was used to account for additional uncertainties for the general population.
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
Although not required at this tonnage band, the DNEL for long-term systemic effects via inhalation and oral routes were derived for the general population to assess potential risk for human via the environment. For inhalation, a route-to-route extrapolation was applied to the oral rat NOAEL of 1 mg/kg bw/day identified in the 90-day repeated toxicity study, and using assessment factors recommended in ECHA Guidance R.8.
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.