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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: 204-876-7 | CAS number: 128-04-1
- 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:
- 0.93 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.6 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11.62 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a 52-week feeding study in dogs with the source substance ziram. The established NOAEL value is equivalent to 3.6 mg technical SDDC/kg bw/day.
To take into account the interspecies difference between dog and human the no observed adverse effect level has to be corrected as follows:
The conversion of an oral NOAEL into an inhalatory NAEC is performed using a breathing volume of 0.137 m³/kg bw/8 h for an 11.5-kg dog. Using the calculated standard minute volume for dogs of 3.281 L/min as given in Bide et al. (1997) an assumed breathing volume of 0.137 m³/kg bw/8 h for an 11.5-kg dog can be calculated.
Corrected inhalatory NAEC = oral NOAEL x1/sRVdog x ABSoral-dog/ABSinh-human x sRVhuman/wRV
= 3.6 mg/kg bw/day x 1/0.137 m³/kg bw x 66%/100% x 6.7 m³/10 m³ = 11.62 mg/m³
sRV: standard respiratory volume, ABS: absorption, wRV: worker respiratory volume
Regarding toxicokinetic behaviour, data with the source substance Ziram were taken into account in the dossier of SDDC (for details please refer to the analogue justification). It could be demonstrated, that Ziram is well absorbed from the gastro-intestinal tract in rats, within 48 h after oral administration for 58-61% after a single low dose, for 60-69% after a single high dose and for 71-75% after a repeated low dose (Hardwick & Lappin, 2001), which means an overall oral absorption of 66%.
Applying the read-across approach, an absorption potential of 66% for the oral route is assumed for SDDC, respectively. Thus, the same absorption value (66% for the oral route), which was taken into account for Ziram, were used for the calculation of the DNELs for SDDC.
Thus, the corrected starting point for inhalation route is 11.62 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used as starting point.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not necessary for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is complete and of high quality.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 2.71 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):
- 17.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.6 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 47.52 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL derived in a 52-week feeding study in dogs with the source substance ziram. This study provides information on the chronic exposure of the source substance, which is considered to be the most reliable for the assessment of hazardous properties during a life span. Moreover, in this study the lowest NOAEL was determined compared with the other repeated dose toxicity studies. The established NOAEL value is equivalent to 3.6 mg technical SDDC/kg bw/day.
Corrected starting point for the dermal route for workers:
Corrected dermal NOAEL = oral NOAEL x ABSoral-rat/ABSdermal-human
= 3.6 mg/kg bw/day x 66% / 5%
= 47.52 mg/kg bw/day
Abs: Absorption
Regarding toxicokinetic behaviour, data with the source substance Ziram were taken into account in the dossier of SDDC. It could be demonstrated, that Ziram is well absorbed from the gastro-intestinal tract in rats, within 48 h after oral administration for 58-61% after a single low dose, for 60-69% after a single high dose and for 71-75% after a repeated low dose (Hardwick & Lappin, 2001), which means an overall oral absorption of 66%. Percutaneous absorption of ziram has been studied in vivo (Cheng, 1991) in the rat and in vitro (Kane, 2006) using human skin samples. Because of the volatile nature of the two metabolites, CS2 and dimethylamine (DMA), the recovery of radioactivity in the in vivo assay in rats was only 70-80%. The non-recovered radioactivity was assumed to be dermally absorbed giving rise to a dermal absorption between 5% (high dose) to almost 30% (low dose). Much better recoveries (91-94%) were obtained with an in vitro human skin model. Both with concentrated (approximately 64% w/v) and diluted aqueous solutions (approximately 0.16% w/v) of Ziram, absorption through human skin was slow (0.004 and 0.05 μg/cm²/h for low and high dose, respectively) and inefficient (2.2% and 0.1% for low and high dose, respectively).
Applying the read-across approach (for details please refer to the analogue justification), an absorption potential of 66% for the oral route and 5% for the dermal route is assumed for SDDC, respectively. Thus, the same absorption values (66% for the oral route and 5% for the dermal route), which were taken into account in the registration dossier with Ziram, were used for the calculation of the DNELs for SDDC.
Thus, the corrected starting point for dermal route is 47.52 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used as starting point.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- default for dog-to-human
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is complete and of high quality.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.23 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.6 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 5.78 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL observed in a 52-week feeding study in dogs with the source substance ziram. The established NOAEL value is equivalent to 3.6 mg technical SDDC/kg bw/day.
To take into account the interspecies difference between dog and human the no observed adverse effect level has to be corrected as follows:
The conversion of an oral NOAEL into an inhalatory NAEC is performed using an assumed breathing volume of 0.411 m³/kg bw/24 h for an 11.5-kg dog. Using the calculated standard minute volume for dogs of 3.281 L/min as given in Bide et al. (1997) an assumed breathing volume of 0.411 m³/kg bw/24 h for an 11.5-kg dog can be calculated.
Corrected inhalatory NAEC = oral NOAEL x1/sRVdog x ABSoral-dog/ABSinh-human x sRVhuman/wRV
= 3.6 mg/kg bw/day x 1/0.411 m³/kg bw x 66%/100% x 6.7 m³/10 m³ = 5.78 mg/m³
sRV: standard respiratory volume, ABS: absorption, wRV: worker respiratory volume
Regarding toxicokinetic behaviour, data with the source substance Ziram were taken into account in the dossier of SDDC (for details please refer to the analogue justification). It could be demonstrated, that Ziram is well absorbed from the gastro-intestinal tract in rats, within 48 h after oral administration for 58-61% after a single low dose, for 60-69% after a single high dose and for 71-75% after a repeated low dose (Hardwick & Lappin, 2001), which means an overall oral absorption of 66%.
Applying the read-across approach, an absorption potential of 66% for the oral route is assumed for SDDC, respectively. Thus, the same absorption value (66% for the oral route), which was taken into account for Ziram, were used for the calculation of the DNELs for SDDC.
Thus, the corrected starting point for inhalation route is 5.78 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used as starting point.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not necessary for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The database is complete and of high quality.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 1.35 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 35
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.6 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 47.52 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral NOAEL derived in a 52-week feeding study in dogs with the source substance ziram.This study provides information on the chronic exposure of the source substance, which is considered to be the most reliable for the assessment of hazardous properties during a life span. Moreover, in this study the lowest NOAEL was determined compared with the other repeated dose toxicity studies.The established NOAEL value is equivalent to 3.6 mg technical SDDC/kg bw/day.
To take into account the interspecies difference between dog and human the no observed adverse effect level has to be corrected as follows:
Corrected dermal NOAEL = oral NOAEL x ABSoral-rat/ABSdermal-human
= 3.6 mg/kg bw/day x 66% / 5%
= 47.52 mg/kg bw/day
Abs: Absorption
Regarding toxicokinetic behaviour, data with the source substance Ziram were taken into account in the dossier of SDDC. It could be demonstrated, that Ziram is well absorbed from the gastro-intestinal tract in rats, within 48 h after oral administration for 58-61% after a single low dose, for 60-69% after a single high dose and for 71-75% after a repeated low dose (Hardwick & Lappin, 2001), which means an overall oral absorption of 66%. Percutaneous absorption of ziram has been studied in vivo (Cheng, 1991) in the rat and in vitro (Kane, 2006) using human skin samples. Because of the volatile nature of the two metabolites, CS2 and dimethylamine (DMA), the recovery of radioactivity in the in vivo assay in rats was only 70-80%. The non-recovered radioactivity was assumed to be dermally absorbed giving rise to a dermal absorption between 5% (high dose) to almost 30% (low dose). Much better recoveries (91-94%) were obtained with an in vitro human skin model. Both with concentrated (approximately 64% w/v) and diluted aqueous solutions (approximately 0.16% w/v) of Ziram, absorption through human skin was slow (0.004 and 0.05 μg/cm²/h for low and high dose, respectively) and inefficient (2.2% and 0.1% for low and high dose, respectively).
Applying the read-across approach (for details please refer to the analogue justification), an absorption potential of 66% for the oral route and 5% for the dermal route is assumed for SDDC, respectively. Thus, the same absorption values (66% for the oral route and 5% for the dermal route), which were taken into account in the registration dossier with Ziram, were used for the calculation of the DNELs for SDDC.
Thus, the corrected starting point for inhalation route is 47.52 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used as starting point.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- default for dog-to-human
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The database is complete and of high quality.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 0.1 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):
- 35
- Dose descriptor starting point:
- NOAEL
- Value:
- 3.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation not necessary
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used as starting point.
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- default for dog-to-human
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is complete and of high quality.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
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.