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Diss Factsheets
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EC number: 203-400-5 | CAS number: 106-46-7
- 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:
- 46.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 230.65 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- In a repeated dose inhalation toxicity study in rats that were exposed 6 hours/day 5 days/week over 2 years the NOAEC(rat) is 75 ppm for systemic effects in liver and kidneys as well as local effects at the respiratory tract (Aiso 2005)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- the DNEL is derived from a long term toxicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- this allometric scaling factor is already included in the extrapolation NOAEC (rat) to NOAEC (human)
- AF for other interspecies differences:
- 1
- Justification:
- due to the complete database covering a wide variety of animals species
- AF for intraspecies differences:
- 5
- Justification:
- worker, as adviced in ECHA Guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- There is information available to cover all relevant toxicological endpoints. The available studies are of high or at least of a very good quality because they are mostly performed according to or equivalent to the current guidelines.
- AF for remaining uncertainties:
- 1
- Justification:
- In an evaluation by ECETOC 2003 and 2010 it is considered that routine application of the factor 2.5 as default factor is scientifically unjustified. In addition, the complete database covers wide variety of animals species
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 300 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: EU ILV
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 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):
- 7
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There is no long term dermal study available. Therefore the long term dog study was taken into account because it was demonstrated that the dog is more susceptible to p-dichlorobenzene than rodent. Furthermore, under the assumption that dermal absorption is in the same range as oral absorption the oral NOAEL is considered as NOAEL (dermal, long term). This procedure is in line with ECHA guidance Document R8
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- the DNEL is derived from a long term study
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- dog versus human
- AF for other interspecies differences:
- 1
- Justification:
- Due to the complete dtabase covering a wie variety of species
- AF for intraspecies differences:
- 5
- Justification:
- worker, as adviced By ECHA guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- There is information available to cover all relevant toxicological endpoints. The available studies are of high or at least of a very good quality because they are mostly performed according to or equivalent to the current guidelines.
- AF for remaining uncertainties:
- 1
- Justification:
- In an evaluation by ECETOC 2003 and 2010 it is considered that routine application of the factor 2.5 as default factor is scientifically unjustified. In addition, the complete database covers wide variety of animals species
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 mg/kg bw/day
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Calculated DNELs: worker
ENDPOINT | CALCULATED DNEL |
DNEL SHORT TERM |
|
Inhalation worker | 50 ppm |
Dermal worker | 7 mg/kg bw/d |
DNEL REPEATED DOSE TOXICOLOGY | |
Oral worker | 1.4 mg/kg bw/d |
Inhalation worker | 7.5 ppm |
Dermal worker |
1.4 mg/kg bw/d |
DNEL REPRODUCTIVE TOXICOLOGY: DEVELOPMENTAL TOXICOLOGY | |
Oral worker | 12.5 mg/kg bw/d |
Inhalation worker |
51 ppm |
Dermal worker | 12.5 mg/kg bw/d |
DNEL for Fertility and Developmental Toxicity
p-Dichlorobenzene does not affect fertility or dervelopment in the absence of general toxicity. Therefore, the DNEL long term covers reproductive toxicity and no seperate DNELS were calculated.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 81.96 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- In a repeated dose inhalation toxicity study in rats that were exposed 6 hours/day 5 days/week over 2 years. The NOAEC(rat) is 75 ppm for systemic effects in liver and kidneys as well as local effects at the respiratory tract (Aiso 2005). For the general public the exposure period is 24h/day and 7 days per week. 75 ppm= 459 mg/m³/6h= 114.75 mg/m³/24h [ 1 ppm=6.12 mg/m³]. 114.75 mg/m³/24h /5 d * 5/7= 81.96 mg/m³/24h/7d
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- the DNEL is derived from a long term study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- this allometric scaling factor is already included in the extrapolation NOAEC (rat) to NOAEC (human)
- AF for other interspecies differences:
- 1
- Justification:
- due tothe complete database covering a wide variety of animal species
- AF for intraspecies differences:
- 10
- Justification:
- general public, as adviced By ECHA Guidance Document R8
- AF for the quality of the whole database:
- 1
- Justification:
- There is information available to cover all relevant toxicological endpoints. The available studies are of high or at least of a very good quality because they are mostly performed according to or equivalent to the current guidelines.
- AF for remaining uncertainties:
- 1
- Justification:
- In an evaluation by ECETOC 2003 and 2010 it is considered that routine application of the factor 2.5 as default factor is scientifically unjustified. In addition, the complete database covers wide variety of animals species
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 300 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 690 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- A DNEL (short term) should be derived if any acute toxicity hazard has been identified and there is a potential for high peak exposure. High peak exposures are usually for the inhalation route. This takes into consideration local and systemic toxicity. For 1,4-dichlorobenzene a LC50 (rat) greater than 5070 mg/m³ and a LOAEC of 5070 mg/m³ is available (Signs during exposure: closing of eyes, wetness around the mouth, fluid discharge from the mouth, exaggerated respiratory movements; signs during observation period: increased respiration rate, wet fur around snout and jaws, yellow staining around the urogenital region, piloerection and brown staining of snout and jaws; the signs persisted for up to 4 hours following exposure but all rats were normal in appearance and behaviour by day 1 of observation period)(Hardy 1987) LOAEC (acute toxicty: 5070 mg/m³/4h. 5070 :3 = 1690 mg/m³/4 h
- AF for intraspecies differences:
- 10
- Justification:
- general public; as adviced by ECHA guidance
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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):
- 14
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There is no long term dermal study available. Therefore the long term dog study was taken into account because it was demonstrated that the dog is more susceptible to p-dichlorobenzene than rodent. Furthermore, under the assumption that dermal absorption is in the same range as oral absorption the oral NOAEL is considered as NOAEL (dermal, long term). This procedure is in line with ECHA guidance Document R8
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- the DNEL is derived from along term study
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- dog versus human
- AF for other interspecies differences:
- 1
- Justification:
- due to the complete databalse covering a wide variety of animal species
- AF for intraspecies differences:
- 10
- Justification:
- general public: as adviced by ECHA Guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- There is information available to cover all relevant toxicological endpoints. The available studies are of high or at least of a very good quality because they are mostly performed according to or equivalent to the current guidelines.
- AF for remaining uncertainties:
- 1
- Justification:
- In an evaluation by ECETOC 2003 and 2010 it is considered that routine application of the factor 2.5 as default factor is scientifically unjustified. In addition, the complete database covers wide variety of animals species
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route extrapolation necessary. There is a reliable long term dog study available which resuted in a NOAEL of 10 mg /kg bw/day after an application of one year. With the result in this study it is shown that the dog is as susceptible to the treatment with p-dichlorobenzene as rondent
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- the DNEL is derived from a long term study
- AF for interspecies differences (allometric scaling):
- 1.4
- Justification:
- dog versus human
- AF for other interspecies differences:
- 1
- Justification:
- due to the complete database covering a wide variety of animal speci
- AF for intraspecies differences:
- 10
- Justification:
- general public: as adviced by ECHA guidance document R8
- Justification:
- There is information available to cover all relevant toxicological endpoints. The available studies are of high or at least of a very good quality because they are mostly performed according to or equivalent to the current guidelines.
- Justification:
- In an evaluation by ECETOC 2003 and 2010 it is considered that routine application of the factor 2.5 as default factor is scientifically unjustified. In addition, the complete database covers wide variety of animals species
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/kg bw/day
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Calculated DNELS: general population
ENDPOINT | CALCULATED DNEL |
DNEL SHORT TERM | |
Inhalation general population | 50 ppm |
dermal general population | 3.5 mg/kg bw |
oral general population | 3.5 mg/kg bw |
DNEL REPEATED DOSE TOXICOLOGY | |
Dermal general population | 0.7 mg/kg bw/d |
Oral general population | 0.7 mg/kg bw/d |
Inhalation general population | 1.3 ppm |
DNEL REPRODUCTIVE TOXICOLOGY: DEVELOPMENTAL TOXICOLOGY | |
Oral general population | 6.25 mg/kg bw/d |
Inhalation general population |
8.5 ppm |
Dermal general population | 6.25 mg/kg bw/d |
DNEL for Fertility and Developmental Toxicity
p-Dichlorobenzene does not affect fertility or dervelopment in the absence of general toxicity. Therefore, the DNEL long term covers reproductive toxicity and no seperate DNELS were calculated.
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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