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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 235-921-9 | CAS number: 13048-33-4
- 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:
- 24.5 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):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 440.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL from the repeated dose study was converted to an inhalatory NOAEC according to the following formula. NOAEC = NOAEL / resp. volume (rat) x (resp. volume (human) / resp. volume (human, light activity)) x (absorption (dermal) / absorption (inhal.)) = 250mg/kg b.w. / 0.38m³/kg b.w. x 0.67 x 1 = 440.8mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already considered during route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Besides the applied allometric scaling factors no additional interspecies factor for remaining differences has been used. In the oral repeated dose study, the NOAEL is based on few changes in serum chemistry without histopathological changes. Additionally, rats were treated for almost 50 days, which is significantly longer than the 28days in a subacute study. Thus the factor of 6 for extrapolation of duration already contains an additional safety factor.
- AF for intraspecies differences:
- 3
- Justification:
- Based on ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor
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)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.77 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):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 66.5 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- This factor describes the differences in metabolic rate between rats and humans based on body weight and is generally applicable to renally excreted substances.
- AF for other interspecies differences:
- 1
- Justification:
- Within the ERASM project, studies in rats and mice were being examined to substantiate whether the factors for allometry and 'remaining‘ differences would be appropriate for these species. The results suggest that a factor of 2.5 for 'remaining‘ interspecies differences may be questionable as a default factor (Escher and Mangelsdorf, 2009; Batke et al, 2011; Bitsch et al, 2006). Additionally, effects in the high dose animals were limited to an unspecific reduction of body weightin male animals only. The NOAEL thus already represent a worst case approach, and no additional safety factor is considered necessary.
- AF for intraspecies differences:
- 3
- Justification:
- Systemic toxicity is limited to reduced body weight in male rats. Since no other parameters were affected, this change is likely secondary to bad general state associated with severe irritation. No large intraspecied differences are expected an a factor of 3 is considered sufficient in this case.
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- default 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:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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:
- 7.2 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):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The substance is not classified for acute systemic effects according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already considered during route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Besides the applied allometric scaling factors no additional interspecies factor for remaining differences has been used. In the oral repeated dose study, the NOAEL is based on few changes in serum chemistry without histopathological changes. Additionally, rats were treated for almost 50 days, which is significantly longer than the 28days in a subacute study. Thus the factor of 6 for extrapolation of duration already contains an additional safety factor.
- AF for intraspecies differences:
- 5
- Justification:
- Based on ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- Default 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:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.66 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 66.7 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- This factor describes the differences in metabolic rate between rats and humans based on body weight and is generally applicable to renally excreted substances.
- AF for other interspecies differences:
- 1
- Justification:
- Within the ERASM project, studies in rats and mice were being examined to substantiate whether the factors for allometry and 'remaining‘ differences would be appropriate for these species. The results suggest that a factor of 2.5 for 'remaining‘ interspecies differences may be questionable as a default factor (Escher and Mangelsdorf, 2009; Batke et al, 2011; Bitsch et al, 2006). Additionally, effects in the high dose animals were limited to an unspecific reduction of body weightin male animals only. The NOAEL thus already represent a worst case approach, and no additional safety factor is considered necessary.
- AF for intraspecies differences:
- 5
- Justification:
- Systemic toxicity is limited to reduced body weight in male rats. Since no other parameters were affected, this change is likely secondary to bad general state associated with severe irritation. No large intraspecied differences are expected an a factor of 3 is considered sufficient in this case.
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- default 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:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- This factor describes the differences in metabolic rate between rats and humans based on body weight and is generally applicable to renally excreted substances.
- AF for other interspecies differences:
- 1
- Justification:
- Besides the applied allometric scaling factors no additional interspecies factor for remaining differences has been used. In the oral repeated dose study, the NOAEL is based on few changes in serum chemistry without histopathological changes. Additionally, rats were treated for almost 50 days, which is significantly longer than the 28days in a subacute study. Thus the factor of 6 for extrapolation of duration already contains an additional safety factor.
- AF for intraspecies differences:
- 5
- Justification:
- Based on ECETOC guidance
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- Default 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:
- low hazard (no threshold derived)
Additional information - General Population
It should be stressed that consumer DNELs were only derived for the sake of completeness. The substance is currently not used in consumer applications, and future uses are neither planned nor advised.
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.