Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 252-346-9 | CAS number: 35074-77-2
- 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:
- 10 mg/m³
DNEL related information
- DNEL derivation method:
- other: The general exposure limit for inhalable dust is applied
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
DNEL related information
- DNEL derivation method:
- other: The general exposure limit for inhalable dust is applied
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:
- 42.5 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):
- 35
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 487 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated dermal exposure. Taken into account the physico-chemical properties of the substance, dermal absorption is anticipated to be 10 % of oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dogs and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Identification of relevant dose descriptor
In the rats, the test article caused responses in liver and thyroid that are known to be species specific for this substance class, and therefore, these findings are of no relevance for man. For risk assessment and the derivation of the DNELs, the 90 day oral toxicity study in dogs was therefore qualified as the most relevant study. The dose descriptor chosen was the NOAEL of 148.7 mg/kg/day.
Calculation of DNELs
Systemic, long-term, dermal:
DNEL = NOAEL (oral) / Sum of assessment factors applicable
The dermal route is typically covered by oral route information in the absence of data for this administration route. No data on skin penetration is available for the test article. However, since the test article has a molecular weight of > 500 and the log POW is not within -1 to 4, a skin penetration of 10% can be assumed and the starting point is modified accordingly, resulting in a NOAEL of 1487 mg/kg bw (ECHA GD chapter R7c). The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (worker): 5
Interspecies variations: 2.5
Allometric scaling (rat to human): 1.4
Exposure duration: 2
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 35 was employed for the dermal route.
DNEL= 1487 mg/kg body weight / 35 = 42.5 mg/kg body weight.
Systemic, long-term, inhalative
According to ECHA guidelines, a route to route extrapolation is performed if no information by the inhalative route is available. Following ECHA guidance document Chapter R.8 the NOAEL (oral) has to be adjusted for differences in respiratory volume for test animals and humans and corrected for activity driven differences of respiratory volumes in workers compared to workers in rest, resulting in a corrected starting point of 749.1 mg/m3. The DNEL is calculated as follows: NOAEL (corrected) / Sum of assessment factors applicable.
The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (worker): 5
Interspecies variations: 2.5
Exposure duration: 2
Default factor to account for differences in oral and inhalative absorption properties: 2
Dose-response factor: 1
Quality of whole database factor: 1
The overall assessment factor employed for the inhalation route is therefore 50.
DNEL = 749.1 mg/m3/ 50 = 14.98 mg/m3
However, since the substance is a solid with low solubility for which no relevant systemic hazard was identified by the oral route, the systemic DNEL derived above is considered not relevant. The main hazard results if dusty material is inhaled at doses at which the natural clearance function of the lung is overloaded. To protect against this effect, the general exposure limit of 10 mg/m3 for inhalable dust is applied.
Systemic, short-term, dermal and inhalative
According to the ECHA document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health", a DNEL for acute systemic toxicity should only be derived if an acute systemic toxicity hazard leading to classification is identified. Therefore, because the substance is not classified for acute toxicity according to Directive 67/548/EEC and Regulation 1272/2008/EC, no systemic DNELs for short-term exposures were calculated. Regarding exposure by inhalation, the main hazard results if dusty material is inhaled at doses at which the natural clearance function of the lung is overloaded. To protect against this hazard, the general exposure limit for inhalable dust is applied. This value is considered to give also sufficient protection for acute effects.
Local, long-term and short-term, inhalative
The main hazard results if dusty material is inhaled at doses at which the natural clearance function of the lung is overloaded. To protect against this effect, the general exposure of limit of 10 mg/m3 for inhalable inert dust is applied.
Local, long-term and short-term, dermal
Based on the available key toxicological information, the test item is not subject to classification for skin and eye irritation and skin sensitization (according to 67/548/EEC and EC/1272/2008). Accordingly, no DNELs for local effects following acute/short-term or long-term exposure are derived. This is in line with the ECHA guidance document (Chapter R.8).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.69 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 184.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route).
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 21.2 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):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 487 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated dermal exposure. Taken into account the physico-chemical properties of the substance, dermal absoption is anticipated to be 10 % of oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dogs and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
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):
- 70
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 148.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation is required since a repeated dose oral toxicity study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default extrapolation factor for exposure duration is used: subchronic (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- The default allometric scaling factor for the differences between dogs and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the more heterogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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
Identification of relevant dose descriptor
The dose descriptor chosen is the same as for workers (see above). The NOAEL of 148.7 mg/kg observed in the 90-day repeated dose study in dogs was used as starting point to derive the DNELs.
Calculation of DNELs
Systemic, long-term, dermal:
DNEL = NOAEL (oral) / Sum of assessment factors applicable
The dermal route is typically covered by oral route information in the absence of data for this administration route. No data on skin penetration is available for the test article. However, since the test article has a molecular weight of > 500 and the log POW is not within -1 to 4, a skin penetration of 10% can be assumed and the starting point is modified accordingly, resulting in a NOAEL of 1487 mg/kg bw (ECHA GD chapter R7c). The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (general population): 10
Interspecies variations: 2.5
Allometric scaling (dog to human): 1.4
Exposure duration: 2
Oral to dermal route extrapolation factor: 0.1
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 70 was employed for the dermal route.
DNEL= 1487 mg/kg body weight / 70 = 21.2 mg/kg body weight.
Systemic, long-term, inhalative
Because no inhalation study is available, a route to route extrapolation was performed. The NOAEL (oral) has to be adjusted into a NOAEL (corrected) based on differences in respiratory volumes for test animals (dogs) and humans in accordance to guidance on information requirements and chemical safety assessment, Chapter R.8, ECHA, May 2008. In addition, a default factor of 2 is applied to account for differences in oral and inhalative absorption properties. The corrected starting point here is 184.4 mg/m3 per day. The DNEL is calculated as follows:
NOAEL (corrected) / Sum of assessment factors applicable.
The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (general population): 10
Interspecies variations: 2.5
Exposure duration: 2
Dose-response factor: 1
The overall assessment factor employed for the inhalation route is therefore 50.
DNEL = 184.4 mg/m3/ 100 = 3.69 mg/m3
Systemic, long-term, oral:
The NOAEL of 148.7 mg/kg body weight observed in the subchronic study in dogs was used as starting point for DNEL derivation. The following assessment factors according to "ECHA guidance on information requirements and chemical safety assessment, Chapter R8" were chosen:
Intraspecies differences (general population): 10
Interspecies variations: 2.5
Allometric scaling (dog to human): 1.4
Exposure duration: 2
Dose-response factor: 1
Quality of whole database factor: 1
Overall, an assessment factor of 70 was employed for the dermal route.
DNEL= 148.7 mg/kg body weight / 70 = 2.1 mg/kg body weight.
Systemic, short-term, oral, dermal and by inhalation
According to the ECHA document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose[concentration]-response for human health", a DNEL for acute systemic toxicity should only be derived if an acute systemic toxicity hazard leading to classification is identified. Therefore, because the substance is not classified for acute toxicity according to Directive 67/548/EEC and Regulation 1272/2008/EC, no systemic DNELs for short-term exposures were calculated.
Local, long-term and short-term, dermal
Based on the available key toxicological information, the test item is not subject to classification for skin and eye irritation and skin sensitization (according to 67/548/EEC and EC/1272/2008). Accordingly, no DNELs for local effects following acute/short-term or long-term exposure are derived. This is in line with the ECHA guidance document (Chapter 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.