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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-344-0 | CAS number: 793-24-8
- 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:
- 0.69 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- As the endpoint is reproductive toxicity, there is no adjustment for duration of exposure, as gestation is a finite measure.
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for worker
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- Comprehensive data are available: acute, sub-acute, sub-chronic and chronic toxicity studies.
- AF for remaining uncertainties:
- 1
- Justification:
- Comprehensive data are available: acute, sub-acute, sub-chronic and chronic toxicity studies.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.45 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
The standard extrapolation factor of 5x was used for the short-term DNEL from the long-term DNEL
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:
- 0.19 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- As the endpoint is reproductive toxicity, there is no adjustment for duration of exposure, as gestation is a finite measure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default rat -> human
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- Comprehensive data are available: acute, sub-acute, sub-chronic and chronic toxicity studies.
- AF for remaining uncertainties:
- 1
- Justification:
- Comprehensive data are available: acute, sub-acute, sub-chronic and chronic toxicity studies.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.95 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
The standard extrapolation factor of 5x was use for a short-term DNEL from a long-term
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
Long Term DNEL Derivation for 6PPD
The starting NOAEL was 7 mg/kg/day from an extended 1-generation reproductive toxicity study. In that study, females (and males, but moot to the derivation) were treated with 6PPD daily for 10 weeks of pre-breeding, 2 weeks of breeding followed by 21 days of gestation until parturition. The NOAEL was based on dystocia (difficult delivery) which was observed in both the range-finder, which had a 2-week pre-treatment period and the main study with a 10 week pre-treatment period. As the primary effect observed was part of gestation (parturition) no correction factors for duration of study are applied, as gestation is a fixed time period, and thus there is no adjustment for duration.
Modification of the dose descriptor:
General population long-term inhalation:
NOAEL of 7 mg/kg/day * ECHA default bioavailability of animal oral of 50% to human inhalationof 100%, = 3.5 mg/kg/day. Divided by the standard respiratory volume of 1.35 m3kg bw/24 hr = Adjusted NOAEC of 2.59 mg/m3
Adjustment factors: 2.5 for remaining interspecies, 10 for intraspecies,Total Adjustment factors = 25. As the primary effect observed was part of gestation (parturition) correction factors for duration of study are not applied, as gestation is a fixed time period, and thus there is no adjustment for duration.
General population long term inhalation DNEL =2.59 mg/m3/ 25 =0.10 mg/m3
General population long term oral/dermal:
NOAEL of 7 mg/kg/day. There is no bioavailability difference between animal to human oral exposures, sothe adjusted NOAEL = 7 mg/kg/day
Adjustment factors: 4 for allometric scaling,2.5 for remaining interspecies, 10 for intraspecies, Total Adjustment factors = 100. As the primary effect observed was part of gestation(parturition) correction factors for duration of study are not applied, as gestation is a fixed timeperiod, and thus there is no adjustment for duration.
General population long term inhalation DNEL = 7 mg/kg/day /100=0.07 mg/kg/day
Worker long term dermal:
NOAEL of 7 mg/kg/day. There is no bioavailability difference between animal to human oral exposures. A factor of 1.4 is applied for exposure conditions for anadjusted NOAEL = 9.8 mg/kg/day
Adjustment factors: 4 for allometric scaling,2.5 for remaining interspecies, 5 for intraspecies,Total Adjustment factors = 50. As the primary effect observed was part of gestation (parturition) correction factors for duration of study are not applied, as gestation is a fixed timeperiod, and thus there is no adjustment for duration.
Worker long term oral/dermal DNEL = 9.8 mg/kg/day/50=0.19 mg/kg/day
Worker long term inhalation:
NOAEL of 7 mg/kg/day. ECHA default bioavailability of animal oral of 50% to human inhalation of 100%, = 3.5 mg/kg/day, / 0.38 m3 bw/8hr = 9.21, * 0.67 (respiratory volumes) * 1.4 (exposure conditions) for anadjusted NOAEL = 8.6 mg/m3
Adjustment factors: 2.5 for remaining interspecies, 5 for intraspecies,Total Adjustment factors = 12.5. As the primary effect observed was part of gestation (parturition) correction factors for duration of study are not applied, as gestation is a fixed time period, and thus there is no adjustment for duration.
Worker long term oral/dermal DNEL = 8.6 mg/m3/12.5=0.69 mg/m3
Short Term DNEL Derivation for 6PPD
Short-Term DNEL values are derived based ECHA guidance suggesting that a five-fold difference in the short and long term DNEL is protective in the absence of other data suggesting a more restrictive need.
Type |
Worker |
General Population |
|||
Long Term Inhalation |
0.69 mg/m3 |
0.10 mg/m3 |
|||
Short Term Inhalation |
3.45 mg/m3 |
0.50 mg/m3 |
|||
Long Term Oral/Dermal* |
0.19 mg/kg/day |
0.07 mg/kg/day |
|||
Short Term Oral/Dermal |
0.95 mg/kg/day |
0.35 mg/kg/day |
|||
*Oral worker values are not derived |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- As the endpoint is reproductive toxicity, there is no adjustment for duration of exposure, as gestation is a finite measure.
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for the general population
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Comprehensive data are available: acute, sub-acute, sub-chronic and chronic toxicity studies.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
The standard extrapolation factor of 5x was used for the short-term DNEL from the long-term DNEL
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:
- 0.07 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- As the endpoint is reproductive toxicity, there is no adjustment for duration of exposure, as gestation is a finite measure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for the general population
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for the general population
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
The standard extrapolation factor of 5x was used for the short-term DNEL from the long-term DNEL
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:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- As the endpoint is reproductive toxicity, there is no adjustment for duration of exposure, as gestation is a finite measure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default rat -> humanDefault factor for the general population
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for the general population
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Comprehensive data are available: acute, sub-acute, sub-chronic and chronic toxicity studies.
- AF for remaining uncertainties:
- 1
- Justification:
- Comprehensive data are available: acute, sub-acute, sub-chronic and chronic toxicity studies.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
The standard extrapolation factor of 5x was used for the short-term DNEL from the long-term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Long Term DNEL Derivation for 6PPD
The starting NOAEL was 7 mg/kg/day from an extended 1-generation reproductive toxicity study. In that study, females (and males, but moot to the derivation) were treated with 6PPD daily for 10 weeks of pre-breeding, 2 weeks of breeding followed by 21 days of gestation until parturition. The NOAEL was based on dystocia (difficult delivery) which was observed in both the range-finder, which had a 2-week pre-treatment period and the main study with a 10 week pre-treatment period. As the primary effect observed was part of gestation (parturition) no correction factors for duration of study are applied, as gestation is a fixed time period, and thus there is no adjustment for duration.
Modification of the dose descriptor:
General population long-term inhalation:
NOAEL of 7 mg/kg/day * ECHA default bioavailability of animal oral of 50% to human inhalationof 100%, = 3.5 mg/kg/day. Divided by the standard respiratory volume of 1.35 m3kg bw/24 hr = Adjusted NOAEC of 2.59 mg/m3
Adjustment factors: 2.5 for remaining interspecies, 10 for intraspecies,Total Adjustment factors = 25. As the primary effect observed was part of gestation (parturition) correction factors for duration of study are not applied, as gestation is a fixed time period, and thus there is no adjustment for duration.
General population long term inhalation DNEL =2.59 mg/m3/ 25 =0.10 mg/m3
General population long term oral/dermal:
NOAEL of 7 mg/kg/day. There is no bioavailability difference between animal to human oral exposures, sothe adjusted NOAEL = 7 mg/kg/day
Adjustment factors: 4 for allometric scaling,2.5 for remaining interspecies, 10 for intraspecies, Total Adjustment factors = 100. As the primary effect observed was part of gestation(parturition) correction factors for duration of study are not applied, as gestation is a fixed timeperiod, and thus there is no adjustment for duration.
General population long term inhalation DNEL = 7 mg/kg/day /100=0.07 mg/kg/day
Worker long term dermal:
NOAEL of 7 mg/kg/day. There is no bioavailability difference between animal to human oral exposures. A factor of 1.4 is applied for exposure conditions for anadjusted NOAEL = 9.8 mg/kg/day
Adjustment factors: 4 for allometric scaling,2.5 for remaining interspecies, 5 for intraspecies,Total Adjustment factors = 50. As the primary effect observed was part of gestation (parturition) correction factors for duration of study are not applied, as gestation is a fixed timeperiod, and thus there is no adjustment for duration.
Worker long term oral/dermal DNEL = 9.8 mg/kg/day/50=0.19 mg/kg/day
Worker long term inhalation:
NOAEL of 7 mg/kg/day. ECHA default bioavailability of animal oral of 50% to human inhalation of 100%, = 3.5 mg/kg/day, / 0.38 m3 bw/8hr = 9.21, * 0.67 (respiratory volumes) * 1.4 (exposure conditions) for anadjusted NOAEL = 8.6 mg/m3
Adjustment factors: 2.5 for remaining interspecies, 5 for intraspecies,Total Adjustment factors = 12.5. As the primary effect observed was part of gestation (parturition) correction factors for duration of study are not applied, as gestation is a fixed time period, and thus there is no adjustment for duration.
Worker long term oral/dermal DNEL = 8.6 mg/m3/12.5=0.69 mg/m3
Short Term DNEL Derivation for 6PPD
Short-Term DNEL values are derived based ECHA guidance suggesting that a five-fold difference in the short and long term DNEL is protective in the absence of other data suggesting a more restrictive need.
Type |
Worker |
General Population |
|||
Long Term Inhalation |
0.69 mg/m3 |
0.10 mg/m3 |
|||
Short Term Inhalation |
3.45 mg/m3 |
0.50 mg/m3 |
|||
Long Term Oral/Dermal* |
0.19 mg/kg/day |
0.07 mg/kg/day |
|||
Short Term Oral/Dermal |
0.95 mg/kg/day |
0.35 mg/kg/day |
|||
*Oral worker values are not 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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