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Diss Factsheets
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EC number: 241-922-5 | CAS number: 18015-76-4
- 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:
- 0.98 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 12.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC worker (8h) = (7 mg/kg bw/day/0.38 m³/kg bw) * 6.7 m³/ 10 m³ [where: NAEC is the modified starting point; 7 mg/kg bw/day is the NOAEL for carcinogenicity (NTP, 2005); 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:
- 1
- Justification:
- Chronic data
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Scaling issues just evaluated in modified starting point
- 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:
- No futher uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The tests considered about toxicological information were performed on several salification forms at the same organic molecule; the salts are chloride, acetate and oxalate. In all cases for those end points the toxicological influence of those counter ions is negligible compared to the toxicity and the metabolic pathway of the organic molecule. Therefore all the studies can be used in read-across to assess the related end point.
INHALATION ROUTE
The Derived No Effect Levelfor inhalation long-term exposure is estimated from the No Observed Effect Level obtained from the carcinogenicity experiment coducted over a period of 2 years in rats and mcie.
The No Observed Adverse Effect Level (NOAEL) was established as 7 mg/kg body weight/day (rat).
In general, the calculation of DNELs is based on the observed effect level and has 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
Corrected starting point for the inhalation route for workers: NAEC worker (8h) = (7 mg/kg bw/0.38 m³/kg bw) * 6.7 m³/ 10 m³
[where: NAEC is the modified starting point; 7 mg/kg bw/day is the NOAEL for carcinogenicity (oral route) (NTP, 2005); 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 m³for base level, 10 m³/kgfor light activity)].
Thus, the corrected starting point NAEC was estimated to be 12.3 mg/m³.
Subsequently other assessment factors have been used to derived the DNEL:
- corrections for differences in duration of exposure are not needed
- remaining differences 2.5
- intraspecies differences 5, for worker population
DERMAL ROUTE
Currently there are no available methods to determine thresholds and DNELs for skin sensitizers. Therefore, substances classified as a skin sensitizer category 1, according to the CLP Regulation (EC 1272/2008), should normally result in a qualitative assessment for the moderate level of concern. Skin sensitizers are allocated to the moderate hazard band on the basis that exposure to such substances should be well-controlled.
Since sensitisation is essentially systemic in nature, it is important for the purposes of risk management to acknowledge that skin sensitisation may be acquired by other routes of exposure than dermal. There is therefore a need for cautious use of known contact allergens in products to which consumers or workers may be exposed by inhalation.
The DNEL derived for inhalation route of exposure can be considered as sufficient to reduce a risk of sensitisation by this pathway: the risk management measures and operational conditionsensure theminimumpossible exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.24 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- other: NAEC
- Value:
- 6.09 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC general population (24h) = (7 mg/kg bw/day/1.15 m³/kg bw) [where: NAEC is the modified starting point; 7 mg/kg bw is the NOAEL for carcinogenicity (NTP, 2005); 1.15 m³/kg bw is the default respiratory volume for the rat corresponding to the daily duration of human exposure]
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic data
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Scaling issues just evaluated in modified starting point
- 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:
- No futher uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.07 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- 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:
- 7 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; 7 mg/kg bw/day is the NOAEL for carcinogenicity (NTP, 2005)
- AF for dose response relationship:
- 1
- Justification:
- Data well supported
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic data
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- From 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:
- No futher uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The tests considered about toxicological information were performed on several salification forms at the same organic molecule; the salts are chloride, acetate and oxalate. In all cases for those end points the toxicological influence of those counter ions is negligible compared to the toxicity and the metabolic pathway of the organic molecule. Therefore all the studies can be used in read-across to assess the related end point.
INHALATION ROUTE
The Derived No Effect Levelfor inhalation long-term exposure is estimated from the No Observed Effect Level obtained from the carcinogenicity experiment coducted over a period of 2 years in rats and mcie.
The No Observed Adverse Effect Level (NOAEL) was established as 7 mg/kg body weight/day (rat).
In general, the calculation of DNELs is based on the observed effect level and has 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
Corrected starting point for the inhalation route for general population: NAEC general population (24h) = 7 mg/kg bw/day/1.15 m³/kg bw
[where: NAEC is the modified starting point; 7 mg/kg bw/day is the NOAEL for carcinogenicity (oral route) (NTP, 2005); 1.15 m³/kg bw is the default respiratory volume for the rat corresponding to the daily duration of human exposure].
Thus, the corrected starting point NAEC was estimated to be 6.09 mg/m³.
Subsequently other assessment factors have been used to derived the DNEL:
- corrections for differences in duration of exposure are not needed
- remaining differences 2.5
- intraspecies differences 10, for general population
DERMAL ROUTE
Currently there are no available methods to determine thresholds and DNELs for skin sensitizers. Therefore, substances classified as a skin sensitizer category 1, according to the CLP Regulation (EC 1272/2008), should normally result in a qualitative assessment for the moderate level of concern. Skin sensitizers are allocated to the moderate hazard band on the basis that exposure to such substances should be well-controlled.
Since sensitisation is essentially systemic in nature, it is important for the purposes of risk management to acknowledge that skin sensitisation may be acquired by other routes of exposure than dermal. There is therefore a need for cautious use of known contact allergens in products to which consumers or workers may be exposed by inhalation.
The DNEL derived for inhalation/oral routes of exposure can be considered as sufficient to reduce a risk of sensitisation by this pathway: the risk management measures and operational conditions ensures the minimum possible exposure.
ORAL ROUTE
The Derived No Effect Level for oral long-term exposure is estimated from the No Observed Effect Level obtained from the carcinogenicity assessment. The No Observed Adverse Effect Level (NOAEL) was established as 7 mg/kg body weight/day.
In general, the calculation of DNELs is based on the observed effect level and has 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
Starting point for the oral route for general population: NOAEL = 7mg/kg bw
[where: 7 mg/kg bw/day is the NOAEL for carcinogenicity (oral route) (NTP, 2005)]
No default factor should be introduced when performing on the same route.
Subsequently other assessment factors have been used to derived the DNEL:
- corrections for differences in duration of exposure are not needed
- because the NOAEL was recorded in a study conducted on rats, for interspecies differences the allometric scaling of 4 has been used
- remaining differences 2.5
- intraspecies differences 10, for general population
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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