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EC number: 235-186-4 | CAS number: 12125-02-9
- 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:
- 43.97 mg/m³
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- other: 8 h European limit value for ammonia (2000/39/EC)
- Value:
- 14 mg/m³
- Modified dose descriptor starting point:
- other: 8 h European limit value for ammonia corrected for ammonium chloride (2000/39/EC)
- Value:
- 43.97 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a 8 h European limit value for ammonia (2000/39/EC) is available.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the 8 h European limit value for ammonia (2000/39/EC).
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 1
- Justification:
- Intraspecies differences are fully covered by the 8 h European limit value for ammonia (2000/39/EC).
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 128.9 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):
- 12
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 104.6 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 546.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The dermal DNEL for systemic effects is derived using the NOAEL of > 1104.6 mg/kg bw obtained from a 30 months oral feeding study in rats (Lina, 2004). The NOAEL is corrected to 1546.4 mg/kg bw by multiplying with 7/5 (to account for differences between exposure frequency in experimental studies and human worker population).
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- An extrapolation factor of 1 was used because the DNEL was derived from an OECD 451 with a treatment duration of 3 months (life time study).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans according to ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8 is used.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 3
- Justification:
- See "Explanation for hazard conclusion".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- low hazard (no threshold derived)
Additional information - workers
Based on the physico-chemical properties as well as reported uses of ammonium chloride, exposure of the human worker population via skin and inhalation are considered to be relevant routes of exposure. Therefore, DNELs for the dermal and inhalation route are derived.
Relevant Toxicology Data
Ammonium chloride is harmful if swallowed (UN GHS Category 4 oral; CLP). The oral route is however not an anticipated route of exposure for the worker population. Ammonium chloride also causes irritation upon contact with the eye. Since available data does not show dose-response correlations, a DN(M)EL for local irritation to the eye can not be derived. A qualitative assessment of this endpoint will be performed.
Workers - Hazard via inhalation
In several EU member states, an occupational exposure limit (OEL) (of 10 mg/m³) already exists for ammonium chloride fumes and inhalable dusts. In Switzerland, a limit value of 3 mg/m³ is in place for respirable ammonium chloride aerosols. In our product, respirable particles which can reach the alveolar region of the lung are not present. Therefore the above DNEL of 43.97 mg/m³, which was derived based on the European Limit Value of ammonia sufficiently covers any risk for the particle size distribution present. In case of a further pulverization of the BASF product (by a down stream user) such that the percentage of inhalable and respirable particles should increase, a new harzard and risk assessment of the modified product will be needed.
Workers – Hazard via dermal route
Step
1: Selection of the relevant dose descriptor (starting point):
The
dermal DNEL for systemic effects is derived using the NOAEL of > 1104
mg/kg bw obtained from a 30 months oral feeding study in rats (Lina,
2004).
Step
2: Modification of the starting point
A
worker DNEL (long-term dermal exposure) is derived. As a worst case
consideration, absorption via the oral and dermal routes is assumed to
be equally efficient. Hence to extrapolate from the oral to the dermal
route, a factor of 1 is applied.
Relevant
dose descriptor (NOAEL): 1104.6 mg/kg bw/day
Frequency of exposure used in study: 7 days/week
Frequency of exposure of the worker: 5 days/week
ABS (oral rat): 100 %
ABS (dermal human): 100 %
Corrected dermal NOAEL for worker:
= 1104.6 mg/kg bw/d x (100/100) x 7/5 = 1546.4 mg/kg bw/d.
Step 3: Use of assessment factors: 12
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 1
Intraspecies AF (worker): 3
Exposure duration AF: 1 (life time study)
In conclusion, long term systemic dermal DNEL, workers = 128.9 mg/kg
bw/day
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.4 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):
- 1
- Dose descriptor starting point:
- other: 8 h European limit value for ammonia (2000/39/EC)
- Value:
- 14 mg/m³
- Modified dose descriptor starting point:
- other: 8 h European limit value for ammonia corrected for ammonium chloride (2000/39/EC)
- Value:
- 43.97 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation factor is needed since a 8 h European limit value for ammonia (2000/39/EC) is available, which is already corrected for the prolonged exposure duration of 24 hours (consumers).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the 8 h European limit value for ammonia (2000/39/EC).
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 1
- Justification:
- Intraspecies differences are fully covered by the 8 h European limit value for ammonia (2000/39/EC).
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 55.2 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 104.6 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 104.6 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- An extrapolation factor of 1 was used because the DNEL was derived from an OECD 451 with a treatment duration of 3 months (life time study).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans as described in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.8 is used.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 5
- Justification:
- See "Explanation for hazard conclusion".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 55.2 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 104.6 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 104.6 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- An extrapolation factor of 1 was used because the DNEL was derived from an OECD 451 with a treatment duration of 3 months (life time study).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans as described in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.8 is used.
- AF for other interspecies differences:
- 1
- Justification:
- Interspecies differences including toxicokinetics are fully covered by the allometric scaling. There is no additional evidence for species differences including toxicodynamics. Therefore, no additional factor is used.
- AF for intraspecies differences:
- 5
- Justification:
- See "Explanation for hazard conclusion".
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 55.2 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1
- 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
Based on the physico-chemical properties as well as reported uses of ammonium chloride, exposure of the general population via the oral, dermal and inhalation routes are relevant.
Relevant Toxicology Data
Ammonium chloride is harmful if swallowed (UN GHS Category 4 oral; CLP). It is assumed however that effects occurring after single short term exposure are sufficiently controlled by the long-term DNEL. Ammonium chloride also causes irritation upon contact with the eye (UN GHS Category 2). Since available data does not allow for the derivation of a DN(M)EL, a qualitative assessment of this endpoint was performed.
General population – Hazard via inhalative route
The DNEL for long-term exposure via inhalation for consumers is derived from the eight hour - limit value derived for the worker population, viz. 43.97 mg/m³.
This limit value is corrected for:
the reduced breathing volume of 6.7 m³ for consumers, as opposed to 10 m³ for workers,
the prolonged exposure duration of 24 hours (consumers), as opposed to 8 hours for workers
for differences in exposure frequency: 7 days/week (consumer), 5 days/week (worker).
A factor of 1.67 for intra-species differences is also included.
The inhalation DNEL for the consumer is thus calculated as follows:
[43.97 mg/m³ x (10/6.7) x (8/24) x (5/7)]/1.67 = 9.4 mg/m³.
In conclusion, long term systemic inhalation DNEL, general population = 9.4 mg/m³
General population – Hazard via dermal route
Step
1: Selection of the relevant dose descriptor (starting point):
The
dermal DNEL for systemic effects is derived using the NOAEL of > 1104
mg/kg bw obtained from a 30 months oral feeding study in rats (Lina,
2004).
Step
2: Modification of the starting point
A
general population DNEL (long-term dermal exposure) is derived. As a
worst case consideration, absorption via the oral and dermal routes is
assumed to be equally efficient. Hence to extrapolate from the oral to
the dermal route, a factor of 1 is applied.
Relevant
dose descriptor (NOAEL): 1104.6 mg/kg bw/day
Frequency of exposure used in study: 7 days/week
Frequency
of exposure of general population: 7 days/week
ABS (oral rat): 100 %
ABS (dermal human): 100 %
Corrected dermal NOAEL for worker:
= 1104.6 mg/kg bw/d x (100/100) x 7/7 = 1104.6 mg/kg bw/d
Step 3: Use of assessment factors: 20
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 1
Intraspecies AF (general population): 5
Exposure duration AF: 1 (life time study)
In conclusion, long term systemic dermal DNEL, general population = 55.2 mg/kg bw/day
General population – Hazard via oral route
Step
1: Selection of the relevant dose descriptor (starting point):
The
dermal DNEL for systemic effects is derived using the NOAEL of > 1104
mg/kg bw obtained from a 30 months oral feeding study in rats (Lina,
2004).
Step
2: Modification of the starting point
A
general population DNEL (long-term oral exposure) is derived. To
extrapolate from the oral to the oral route, a factor of 1 is applied.
Relevant
dose descriptor (NOAEL): 1104.6 mg/kg bw/day
Frequency of exposure used in study: 7 days/week
Frequency
of exposure of general population: 7 days/week
Corrected dermal NOAEL for worker:
= 1104.6 mg/kg bw/d x 7/7 = 1104.6 mg/kg bw/d
Step 3: Use of assessment factors: 20
Interspecies AF, allometric scaling (rat to human): 4
Interspecies AF, remaining differences: 1
Intraspecies AF (general population): 5
Exposure duration AF: 1 (life time study)
In conclusion, long term systemic oral DNEL, general population = 55.2 mg/kg bw/day
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