Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 231-836-6 | CAS number: 7758-19-2
- 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:
- 0.28 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3.53 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory N(L)OAEC=oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh) = 4 mg/kg bw/day/0.38+0.67*0.5
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Two-generations study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.28 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3.53 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalatory N(L)OAEC=oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh) = 4 mg/kg bw/day/0.38+0.67*0.5
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
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:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- 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:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on available data on the substance from an in vitro dermal absorption study using human and rat skin, a 10% dermal absorption value is used for the route-to-route extrapolation. Dermal N(L)OAEC=oral (N(L)OAEL*(ABSoral/ABSdermal) = 4 mg/kg bw/day*10.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Two-generations study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 5
- Justification:
- Workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- 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:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on available data on the substance from an in vitro dermal absorption study using human and rat skin, a 10% dermal absorption value is used for the route-to-route extrapolation. Dermal N(L)OAEC=oral (N(L)OAEL*(ABSoral/ABSdermal) = 4 mg/kg bw/day*10.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 5
- Justification:
- Workers.
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
A.- ACUTE TOXICITY. Systemic effects
Oral exposure
Starting point for acute oral effects is NOAEL = 4 mg sodium chlorite/kg bw/day from 2-generations study (Gill et al 2000). Assessment factors are to be applied as follows:
1.- the allometric scaling factor for the rat is 4; The default factor has been used since no data are available to confirm the absence of toxicokinetic or toxicodynamic differences between mammalian species.
2.- a default factor of 2.5 accounts for additional interspecies differences no related to metabolism. The default value has been used since potential non-metabolism differences between species have not been characterized
3.- for intraspecies differences (workers) the default factor is 10 for consumers.
For consumers: DNEL = 4/100= 0.04 mg/kg/day
No oral exposure is likely for workers.
Dermal exposure
Starting point for systemic dermal effects is dermal acute toxicity test: NOAEL = 4 mg sodium chorite/kg bw/day. Taking into account that dermal absorption is, as worst case, 10% (see endpoint 7.1.2), the corrected starting point is 40 mg/kg bw/day. Assessment factors are to be applied as follows:
(1) the allometric scaling factor for the rat is 4;
(2) a default factor of 2.5 accounts for additional interspecies differences;
(3) for intraspecies differences (workers) the default factor is 5; for consumers 10
For consumers: DNEL= 40/100= 0.4 mg/kg/day
For workers: DNEL= 40/50 = 0.80 mg/kg/day
Inhalatory exposure
Starting point is a 2-generations study. Assessment factors were the same as per oral exposure with exception of allometric scale that does not apply: 25 for general population and 12.5 for workers.
Worker Population - NOAEL of 4 mg/kg bw/day*(1/0.38m3/kg)*0.67*(ABSoral/ABSinh) = 4/0.38*0.67*0.5 = 3.53 mg/m3.
General Population - NOAEL of 4 mg/kg bw/day*(1/1.15m3/kg)*(ABSoral/ABSinhal) = 4/1.15*0.5 mg/m3 = 1.74 mg/m3
Applying the above explained AF:
DNEL inhalation, systemic, chronic worker population = 3.53 / 12.5 = 0.28 mg/m3.
DNEL inhalation, systemic, chronic general population = 1.74 / 25 = 0.07 mg/m3.
B.- IRRITATION AND CORROSIVITY
The substance is classified as corrosive as solid form. Due to this known hazard personal protection measures are to be implemented at working place when using the solid. Therefore just accidental dermal exposure is considered.
Quantitative dose descriptor is not possible to derive from available data.
The solution at 31% concentration in water is not irritating (Price 1985b). Therefore no assessment is required for local dermal effects when referring to this preparation.
C.- SENSITIZATION
Due to the corrosivity and high dermal toxicity of the test substance dermal exposure should be avoided. Therefore just accidental exposure is to be considered.
A study with a 31% aqueous solution of the substance was conducted.The mixture does not exhibited experimental evidence of sensitizing potential.
D.- MUTAGENICITY/ CARCINOGENICITY
There were no indications of a non-threshold mutagenic or tumorigenic response. Therefore DNELs have not been established either for carcinogenicity nor mutagenicity.
E.- REPEAT DOSE TOXICITY: Systemic effects
Since the starting point is a two-generations study the assessment factor for duration differences is set in REACH guidance as AF = 1.
Dose-response related issues
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
Quality of whole database
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Dermal exposure
Since no dose descriptor was available from a repeated application dermal toxicity study and dermal exposure is the most probable route of human exposure, it was necessary to derive a corrected dermal NOAEL from the oral NOAEL. The oral dose descriptor was used as the basis for route-to-route extrapolation.
Dermal risk assessment is based on the oral NOAEL of 4 mg/kg bw/day from the 2-generations study.
Based on available data on the substance from an in vitro dermal absorption study using human and rat skin, a 10% dermal absorption value is used for the route-to-route extrapolation.
Therefore, starting from an oral NOAEL of 4 mg/kg bw/day, the dermal NOAEL would be 40 mg/kg/day (4 mg/kg bw/day/0.1).
The following adjustment factors are applied for the identification of the reference MOS:
(1) for duration adjustment a factor of 1 is used
(2) the allometric scaling factor for the rat is 4;
(3) a default factor of 2.5 accounts for additional interspecies differences;
(4) for intraspecies differences (workers) the default factor is 5, for consumers is 10
Applying these factors to the oral NOAEL gives:
DNEL dermal, systemic, chronic general population = 40/100 = 0.40 mg/kg bw/day,
DNEL dermal, systemic, chronic worker population = 40/50 = 0.80 mg/kg bw/day.
Oral exposure
Starting point is NOAEL of 4 mg/kg bw/day. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:
DNEL oral, systemic, chronic general population = 4/100= 0.04 mg/kg bw/day
Inhalatory exposure
For the chronic inhalation exposure DNELs, the corrected NOAEL was derived as a starting point based on the oral NOAEL of 2.9 mg/kg bw/day, since no study data were available from long term repeated exposure investigations via the inhalation route. This route is considered of minor concern due to the vapour pressure of the substance.
The total assessment factor for the worker population, long term DNEL inhalation, systemic = 2.5*5*1*1*1 = 12.5
The total assessment factor for the general population, long term DNEL inhalation, systemic = 2.5*10*1*1*1 = 25
Differences in respiration volumes were assessedfor converting the oral dose to an inhalation concentration:
Worker Population - NOAEL of 4 mg/kg bw/day*(1/0.38m3/kg)*0.67*(ABSoral/ABSinhal) = 4/0.38*0.67*0.5 = 3.53 mg/m3.
General Population - NOAEL of 4 mg/kg bw/day*(1/1.15m3/kg)*(ABSoral/ABSinhal) = 4/1.15*0.5 = 1.74 mg/m3,
Applying the above explained AF:
DNEL inhalation, systemic, chronic worker population = 3.53 / 12.5 = 0.28 mg/m3.
DNEL inhalation, systemic, chronic general population = 1.74 / 25 = 0.07 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.74 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation N(L)OAEC=oral N(L)OAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh)= 4 mg/kg bw/day/1.15*0.5
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Two-generations study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/m³
- Most sensitive endpoint:
- effect on fertility
- 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:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.74 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Inhalation N(L)OAEC=oral N(L)OAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh)= 4 mg/kg bw/day/1.15*0.5
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
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:
- 0.4 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal exposure Starting point for systemic dermal effects is dermal acute toxicity test: NOAEL = 4 mg/kg bw/day. Taking into account that dermal absorption is, as worst case, 10%, the corrected starting point is 40 mg/kg/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Two-generations study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Consumer
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.4 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal exposure Starting point for systemic dermal effects is dermal acute toxicity test: NOAEL = 4 mg/kg bw/day. Taking into account that dermal absorption is, as worst case, 10%, the corrected starting point is 40 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
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:
- 0.04 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point is NOAEL of 4 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Two-generations study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.04 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point is NOAEL of 4 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor
- AF for intraspecies differences:
- 10
- Justification:
- Consumers
- AF for the quality of the whole database:
- 1
- Justification:
- The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
A.- ACUTE TOXICITY. Systemic effects
Oral exposure
Starting point for acute oral effects is NOAEL = 4 mg sodium chlorite/kg bw/day from 2-generations study (Gill et al 2000). Assessment factors are to be applied as follows:
1.- the allometric scaling factor for the rat is 4; The default factor has been used since no data are available to confirm the absence of toxicokinetic or toxicodynamic differences between mammalian species.
2.- a default factor of 2.5 accounts for additional interspecies differences no related to metabolism. The default value has been used since potential non-metabolism differences between species have not been characterized
3.- for intraspecies differences (workers) the default factor is 10 for consumers.
For consumers: DNEL = 4/100= 0.04 mg/kg/day
No oral exposure is likely for workers.
Dermal exposure
Starting point for systemic dermal effects is dermal acute toxicity test: NOAEL = 4 mg sodium chorite/kg bw/day. Taking into account that dermal absorption is, as worst case, 10% (see endpoint 7.1.2), the corrected starting point is 40 mg/kg bw/day. Assessment factors are to be applied as follows:
(1) the allometric scaling factor for the rat is 4;
(2) a default factor of 2.5 accounts for additional interspecies differences;
(3) for intraspecies differences (workers) the default factor is 5; for consumers 10
For consumers: DNEL= 40/100= 0.4 mg/kg/day
For workers: DNEL= 40/50 = 0.80 mg/kg/day
Inhalatory exposure
Starting point is a 2-generations study. Assessment factors were the same as per oral exposure with exception of allometric scale that does not apply: 25 for general population and 12.5 for workers.
Worker Population - NOAEL of 4 mg/kg bw/day*(1/0.38m3/kg)*0.67*(ABSoral/ABSinh) = 4/0.38*0.67*0.5 = 3.53 mg/m3.
General Population - NOAEL of 4 mg/kg bw/day*(1/1.15m3/kg)*(ABSoral/ABSinhal) = 4/1.15*0.5 mg/m3 = 1.74 mg/m3
Applying the above explained AF:
DNEL inhalation, systemic, chronic worker population = 3.53 / 12.5 = 0.28 mg/m3.
DNEL inhalation, systemic, chronic general population = 1.74 / 25 = 0.07 mg/m3.
B.- IRRITATION AND CORROSIVITY
The substance is classified as corrosive as solid form. Due to this known hazard personal protection measures are to be implemented at working place when using the solid. Therefore just accidental dermal exposure is considered.
Quantitative dose descriptor is not possible to derive from available data.
The solution at 31% concentration in water is not irritating (Price 1985b). Therefore no assessment is required for local dermal effects when referring to this preparation.
C.- SENSITIZATION
Due to the corrosivity and high dermal toxicity of the test substance dermal exposure should be avoided. Therefore just accidental exposure is to be considered.
A study with a 31% aqueous solution of the substance was conducted.The mixture does not exhibited experimental evidence of sensitizing potential.
D.- MUTAGENICITY/ CARCINOGENICITY
There were no indications of a non-threshold mutagenic or tumorigenic response. Therefore DNELs have not been established either for carcinogenicity nor mutagenicity.
E.- REPEAT DOSE TOXICITY: Systemic effects
Since the starting point is a two-generations study the assessment factor for duration differences is set in REACH guidance as AF = 1.
Dose-response related issues
Since the DNEL is to be derived from a starting position based on an NOAEL from a good quality study, the dose response assessment factor was the default value, AF = 1.
Quality of whole database
The default assessment factor to be applied is AF = 1. Higher factors may be applied based on scientific judgment related to adequacy and consistency. The database is considered relevant to assessment of repeated dose oral toxicity and is considered adequate, robust and reliable.
Dermal exposure
Since no dose descriptor was available from a repeated application dermal toxicity study and dermal exposure is the most probable route of human exposure, it was necessary to derive a corrected dermal NOAEL from the oral NOAEL. The oral dose descriptor was used as the basis for route-to-route extrapolation.
Dermal risk assessment is based on the oral NOAEL of 4 mg/kg bw/day from the 2-generations study.
Based on available data on the substance from an in vitro dermal absorption study using human and rat skin, a 10% dermal absorption value is used for the route-to-route extrapolation.
Therefore, starting from an oral NOAEL of 4 mg/kg bw/day, the dermal NOAEL would be 40 mg/kg/day (4 mg/kg bw/day/0.1).
The following adjustment factors are applied for the identification of the reference MOS:
(1) for duration adjustment a factor of 1 is used
(2) the allometric scaling factor for the rat is 4;
(3) a default factor of 2.5 accounts for additional interspecies differences;
(4) for intraspecies differences (workers) the default factor is 5, for consumers is 10
Applying these factors to the oral NOAEL gives:
DNEL dermal, systemic, chronic general population = 40/100 = 0.40 mg/kg bw/day,
DNEL dermal, systemic, chronic worker population = 40/50 = 0.80 mg/kg bw/day.
Oral exposure
Starting point is NOAEL of 4 mg/kg bw/day. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:
DNEL oral, systemic, chronic general population = 4/100= 0.04 mg/kg bw/day
Inhalatory exposure
For the chronic inhalation exposure DNELs, the corrected NOAEL was derived as a starting point based on the oral NOAEL of 2.9 mg/kg bw/day, since no study data were available from long term repeated exposure investigations via the inhalation route. This route is considered of minor concern due to the vapour pressure of the substance.
The total assessment factor for the worker population, long term DNEL inhalation, systemic = 2.5*5*1*1*1 = 12.5
The total assessment factor for the general population, long term DNEL inhalation, systemic = 2.5*10*1*1*1 = 25
Differences in respiration volumes were assessedfor converting the oral dose to an inhalation concentration:
Worker Population - NOAEL of 4 mg/kg bw/day*(1/0.38m3/kg)*0.67*(ABSoral/ABSinhal) = 4/0.38*0.67*0.5 = 3.53 mg/m3.
General Population - NOAEL of 4 mg/kg bw/day*(1/1.15m3/kg)*(ABSoral/ABSinhal) = 4/1.15*0.5 = 1.74 mg/m3,
Applying the above explained AF:
DNEL inhalation, systemic, chronic worker population = 3.53 / 12.5 = 0.28 mg/m3.
DNEL inhalation, systemic, chronic general population = 1.74 / 25 = 0.07 mg/m3.
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