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Diss Factsheets
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EC number: 229-761-9 | CAS number: 6711-48-4
- 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:
- 0.82 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 61.71 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As no long-term study on inhalation is available, route-to-route extrapolation has been performed. Data generated with the related substance DEAPA was used to cover the higher tier toxicity endpoints. The NOAEL observed in the prenatal development study in rat of 50 mg/kg bw/d was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 61.71 mg/m³ (50 mg/kg bw/d x 1/(0.38 m³/kg bw/d) x 6.7 m³/10 m³ x 0.5 x 7/5). The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 hours exposure of workers). For workers the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under the respective conditions (6.7 m³ for base level, 10 m³ for light activity). In addition, the NOAEL needed to be divided by 2 as the bioavailability via the inhalation route is considered as 100%, while for oral exposure this is only 50%). A correction factor 7/5 for difference in exposure duration and frequency was added (7 days/week dosing in the animal study, 5 days / week exposure of the workers).
No long term toxicity studies are available for the test substance. Data from a read-across oral prenatal development study with the structurally related substance DEAPA could be used as starting point for extrapolation to the dermal route.
A prenatal development toxicity study in rats was performed according to OECD 414, via oral gavage at dose levels 0, 50, 250 and 750 mg/kg bw/day. The potential toxic effects of DEAPA on the pregnant female rats and on embryonic and fetal development was evaluated and the study reports multiple treatment related effects, observed in the early treatment days of the animals, that have an impact on maternal animals and fetus' chances of survival. At 250 mg/kg bw/d, test item-related clinical signs observed on maternal animals consisted of round back, emaciated appearance, piloerection, loud breathing, and/or reddish vaginal discharge. These clinical signs had dose-related increased incidence and were adverse. Other effects observed at 250 mg/kg bw/d included slightly lower mean gravid uterus weight, higher mean post-implantation loss , lower mean number of live fetuses, litter losses by resorption. Since the developmental toxicity study shows that the test item has an impact on fetus survival, it is recommended to choose a conservative approach, with NOAEL at 50 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point; no additional assessment factor required
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration, subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Covered by calculation for route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.23 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 70 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long term toxicity studies are available for the test substance. Data from a read-across oral preclinical development toxicity study with the structurally related substance DEAPA could be used as starting point for extrapolation to the dermal route.
A prenatal development toxicity study in rats was performed according to OECD 414, via oral gavage at dose levels 0, 50, 250 and 750 mg/kg bw/day. The potential toxic effects of DEAPA on the pregnant female rats and on embryonic and fetal development was evaluated and the study reports multiple treatment related effects, observed in the early treatment days of the animals, that have an impact on maternal animals and fetus' chances of survival. At 250 mg/kg bw/d, test item-related clinical signs observed on maternal animals consisted of round back, emaciated appearance, piloerection, loud breathing, and/or reddish vaginal discharge. These clinical signs had dose-related increased incidence and were adverse. Other effects observed at 250 mg/kg bw/d included slightly lower mean gravid uterus weight, higher mean post-implantation loss , lower mean number of live fetuses, litter losses by resorption. Since the developmental toxicity study shows that the test item has an impact on fetus survival, it is recommended to choose a conservative approach, with NOAEL at 50 mg/kg bw/d.
For route-to-route extrapolation (oral to dermal), no default factor (i.e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption. A correction factor of 7/5 is applied to correct for difference in exposure duration and frequency (7 days / week for the animal study, 5 days/week for the workers).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point; no additional assessment factor is required.
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in duration, subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- 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:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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:
- 0.434 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As no long-term study on inhalation is available, route-to-route extrapolation has been performed. Data generated with the related substance DEAPA was used to cover the higher tier toxicity endpoints. The NOAEL observed in the prenatal development study in rat of 50 mg/kg bw was used to derive a DNEL long-term, systemic effects via the inhalation route. For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 21.7 mg/m³ (50 mg/kg bw/d x 1/(1.15 m³/kg bw/d) x 50%/100%). The NOAEL needed to be divided by 2 as the bioavailability via the inhalation route is considered as 100%, while for oral exposure this is only 50%). No long term toxicity studies are available for the test substance. Data from a read-across oral prenatal development study with the structurally related substance DEAPA could be used as starting point for extrapolation to the inhalation route route. A prenatal development toxicity study in rats was performed according to OECD 414, via oral gavage at dose levels 0, 50, 250 and 750 mg/kg bw/day. The potential toxic effects of DEAPA on the pregnant female rats and on embryonic and fetal development was evaluated and the study reports multiple treatment related effects, observed in the early treatment days of the animals, that have an impact on maternal animals and fetus' chances of survival. At 250 mg/kg bw/d, test item-related clinical signs observed on maternal animals consisted of round back, emaciated appearance, piloerection, loud breathing, and/or reddish vaginal discharge. These clinical signs had dose-related increased incidence and were adverse. Other effects observed at 250 mg/kg bw/d included slightly lower mean gravid uterus weight, higher mean post-implantation loss , lower mean number of live fetuses, litter losses by resorption. Since the developmental toxicity study shows that the test item has an impact on fetus survival, it is recommended to choose a conservative approach, with NOAEL at 50 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point; no additional assessment factor required
- AF for differences in duration of exposure:
- 2
- Justification:
- difference in duration, sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- is included in the route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long term toxicity studies are available for the test substance. Data from a read-across oral preclinical development toxicity study with the structurally related substance DEAPA could be used as starting point for extrapolation to the dermal route.
A prenatal development toxicity study in rats was performed according to OECD 414, via oral gavage at dose levels 0, 50, 250 and 750 mg/kg bw/day. The potential toxic effects of DEAPA on the pregnant female rats and on embryonic and fetal development was evaluated and the study reports multiple treatment related effects, observed in the early treatment days of the animals, that have an impact on maternal animals and fetus' chances of survival. At 250 mg/kg bw/d, test item-related clinical signs observed on maternal animals consisted of round back, emaciated appearance, piloerection, loud breathing, and/or reddish vaginal discharge. These clinical signs had dose-related increased incidence and were adverse. Other effects observed at 250 mg/kg bw/d included slightly lower mean gravid uterus weight, higher mean post-implantation loss , lower mean number of live fetuses, litter losses by resorption. Since the developmental toxicity study shows that the test item has an impact on fetus survival, it is recommended to choose a conservative approach, with NOAEL at 50 mg/kg bw/d.
For route-to-route extrapolation (oral to dermal), no default factor (i.e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point; no additional assessment factor is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Difference in duration, sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- 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:
- 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:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long term toxicity studies are available for the test substance. Data from a read-across oral preclinical development toxicity study with the structurally related substance DEAPA could be used as starting point for extrapolation to the oral route.
A prenatal development toxicity study in rats was performed according to OECD 414, via oral gavage at dose levels 0, 50, 250 and 750 mg/kg bw/day. The potential toxic effects of DEAPA on the pregnant female rats and on embryonic and fetal development was evaluated and the study reports multiple treatment related effects, observed in the early treatment days of the animals, that have an impact on maternal animals and fetus' chances of survival. At 250 mg/kg bw/d, test item-related clinical signs observed on maternal animals consisted of round back, emaciated appearance, piloerection, loud breathing, and/or reddish vaginal discharge. These clinical signs had dose-related increased incidence and were adverse. Other effects observed at 250 mg/kg bw/d included slightly lower mean gravid uterus weight, higher mean post-implantation loss , lower mean number of live fetuses, litter losses by resorption. Since the developmental toxicity study shows that the test item has an impact on fetus survival, it is recommended to choose a conservative approach, with NOAEL at 50 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point; no additional assessment factor is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Difference in duration, sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- default assessment factor
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment 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:
- medium hazard (no threshold derived)
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.