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EC number: 220-290-4 | CAS number: 2702-72-9
- 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:
- 1.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
DNEL – short-term, Worker
The calculations for the long term DNELs for workers are based on a 90-day oral feeding study performed in Fischer 344 rats. The NOAEL in this study was found to be 15 mg/kg bw/d (acid equivalents). This value was used as basis for DNEL calculation.
The molecular weight of sodium 2,4-D is only 10% higher than that of 2,4-D acid. Thus, no MW correction is applied to the point of departure.
Route-to-route extrapolation (oral to inhalative) was performed according to the ECHA Guidance Document R.8. Test animals were exposed on 7 days a week. For workers, the expected exposure is only 5 days a week. Therefore, a factor of 7/5 was introduced for workers due to the expsure pattern (working time of 5 days a week).
Starting point (worker, inhalative) = oral NOAEL × 1/sRVrat× sRVhuman/wRV × 7/5 = 15 mg/kg bw/d ÷ 0.38 m³/kg bw/d × 6.7m³/10m³ × 7/5 = 37 mg/m³
Based on human data for 2,4-D acid, 2% dermal absorption is expected (see Section 7.1.2 for details). Therefore a factor of 0.02 for the difference in absorption was introduced for extrapolation from oral to dermal route.
Corrected starting point (worker, dermal) = oral NOAEL × 7/5 ÷ 0.02 = 15 mg/kg bw/d ÷ 0.02 × 7/5 =1050 mg/kg bw/d
For the calculation of the DNEL, the following safety factors were applied on the corrected starting points:
Dermal DNEL: allometric scaling factor 4; remaining differences 2.5; intraspecies factor 5; exposure duration factor 1; dose-response factor 1; quality of the database 1 =50
Inhalation DNEL: remaining differences 2.5; intraspecies factor 5; exposure duration factor 1; dose-response factor 1; quality of the database 1 =12.5
Taken together, the resulting short-term DNELs for workers are
dermal DNEL =1050 mg/kg bw/d ÷ 50 = 21 mg/kg bw/d
inhalation DNEL = 37 mg/m³ ÷ 12.5 =3.0 mg/m³
DNEL –long-term, Worker
The long-term DNELs for worker are based on the same subchronic NOAEL as the short-term DNELs. Therefore, an additional AF of 2 is applied to account for assessing chronic exposures with subchronic study data. Thus, the long-term DNELs are half as high as the short-term DNELs.
The resulting long-term DNELs for workers are
dermal DNEL = 1050 mg/kg bw/d ÷ 100 = 10.5 mg/kg bw/d
inhalation DNEL = 37 mg/m³ ÷ 25 = 1.5 mg/m³
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.26 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.52 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
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:
- 5.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.5 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Additional information - General Population
DNEL – short-term, General Population
According to the ECHA guidance document R.8 (characterization of dose[concentration]-response for human health), a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures. This DNEL can be based on repeated dose data if the lethality data is considered to involve too large uncertainties.
The calculations for the short- term DNELs for the general population are therefore also based on a 90-day oral feeding study performed in Fischer 344 rats. The NOAEL in this study was found to be 15 mg/kg bw/d (acid equivalents). This value was used as basis for DNELcalculation.
The molecular weight of sodium 2,4-D is only 10% higher than that of 2,4-D acid. Thus, no MW correction is applied to the point of departure.[VM1]
Route to route extrapolation (oral to inhalative) was performed according to the ECHA Guidance Document R.8.
The calculation of the corrected starting points for the general population (gen pop) is as follows:
Corrected starting point (gen pop[VM2] , inhalative) = oral NOAEL × 1/sRVrat=
15 mg/kg bw/d ÷ 1.15 m3/kg bw/d =13 mg/m3/d
Based on human data for 2,4-D acid, 2% dermal absorption is expected (see Section 7.1.2 for details). Therefore a factor of 0.02 for the difference in absorption was introduced for extrapolation from oral to dermal route.[VM3]
Corrected starting point (gen pop, dermal) = oral NOAEL /0.02 =1050 mg/kg bw/d
For the calculation of the short-term DNEL, the following safety factors were applied on the corrected starting points:
In deviation to the situation of the workers, the assessment factor for intraspecies variability was set to 10 to account for more variability in the general population.
Dermal DNEL: allometric scaling factor 4; remaining differences 2.5; intraspecies factor 10; exposure duration factor 1; dose-response factor 1; quality of the database 1 =100
Inhalation DNEL: remaining differences 2.5; intraspecies factor 10; exposure duration factor 1; dose-response factor 1; quality of the database 1 =25
Oral DNEL: allometric scaling factor 4; remaining differences 2.5; intraspecies factor 10; exposure duration factor 1; dose-response factor 1; quality of the database 1 =100
Taken together, the resulting short-term DNELs for the general population are
dermal DNEL =1050 mg/kg bw/d ÷ 100 = 10.5 mg/kg bw/d
inhalation DNEL = 13 mg/m³ ÷ 25 = 0.52 mg/m³
oral DNEL = 15 mg/kg bw/day ÷ 100 = 0.15 mg/kg bw/d
DNEL – long-term, General Population
For reasons of regulatory consistency, the ADI for the active substance 2,4-D (0.05 mg/kg bw/day) set by the European Commission under Directive 91/414/EEC is also adopted as oral long-term DNEL for the general population. The ADI is based on long-term feeding studies in rats and mice and an AF of 100
The dermal and inhalation long-term DNELs for the general population are based on the same subchronic NOAEL as the short-term DNELs. Therefore, an additional AF of 2 is applied to account for assessing chronic exposures with subchronic study data. Thus, the long-term DNELs are half as high as the short-term DNELs.
The resulting long-term DNELs for the general population are
dermal DNEL = 1050 mg/kg bw/d ÷ 200 = 5.3 mg/kg bw/d
inhalation DNEL = 13 mg/m³ ÷ 50 = 0.26 mg/m³
oral DNEL = ADI = 0.05 mg/kg bw/dInformation 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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