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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 232-216-8 | CAS number: 7790-62-7
- 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:
- 0.13 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 006 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 886 mg/kg was derived from a 13-week subchronic oral toxicity study with ammonium sulphate in F344 rats. This study was selected over a chronic bioassay in which a slight increase was observed in kidney weights and chronic progressive nephropathy (in male rats without clear dose response) was reported at ammonium sulphate dietary doses of 1.5 and 3%. Chronic nephropathy in male rats is likely a degenerative response of limited relevance for humans, thus the true NOAEL is likely higher than 1.5%. In the 13-week study, diarrhoea was observed in male rats at a dietary level 3%, corresponding to 1792 mg/kg; the NOAEL was 1.5% (886 mg/kg). Although diarrhoea was not observed at any dose in the chronic bioassay, it was considered to be the key effect for deriving a DNEL. No changes in body weights, organ weights, haematological, serum biochemical or histopathological parameters were observed so the 13-week study NOAEL is a conservative estimate of systemic toxicity. Diarrhoea is likely a direct response of the change of isotonicity in intestinal tract contents. Sulphate anion may have reduced osmotic pressure in the intestinal lumen, causing a net water influx, resulting in osmotic diarrhoea. The starting point from the 13-week study was modified for the appropriate dose descriptors, i.e., molecular weight differences between ammonium sulphate and the notified substance (254/132 or 1.92), allometric scaling for rodent to worker respiration (1/0.38 m3/kg bw), and normal human to worker respiratory volume correction for light activity (6.7 m3/10 m3) per REACH guidance R.8.4.2. As described above, the expected systemic toxicity is likely to be of secondary importance compared to the local effects. Thus, the more conservative inhalation local, long term DNEL for sulphuric acid of 0.13 mg/m3 should be utilized for purposes of risk assessment.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is a conservative NOAEL from a 13-week dietary exposure study in rats. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- The observed adverse outcome in a 13-week dietary exposure study was limited to diarrhoea, an outcome likely associated with osmotic imbalance due to high exposure levels of the notified substance. While diarrhoea was not observed in a chronic bioassay with ammonium sulphate in either male or female F344 rats at the same dose levels, diarrhoea was considered to represent an adverse effect. Data were not available to assess the relationship of the key effect with exposure duration. Accordingly, an assessment factor of 2 is a conservative value for study duration per REACH guidance R8.4.3.2.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Since the conversion of the starting point by the respiratory rate scaling factor between rats and humans was utilized (i.e., 1/0.38 m3/kg), no further assessment factor for allometric scaling is necessary for oral to inhalation route of exposure extrapolation per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 1
- Justification:
- No overt systemic toxicity was observed from clinical chemical, body or organ weight, or pathological endpoints in the key study. Diahhrea is likely a direct response of the change in isotonicity of intestinal tract contents. Unabsorbed or excessive sulphate anion may reduce the osmotic pressure in the intestinal lumen, causing a net water flow into the lumen, resulting in osmotic diarrhea. This is likely a local effect, associated with high local concentrations of sulphate anion in the luminal contents. Accordingly, an assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- A default factor of 5 for workers is appropriate according to REACH guidance in R.8.4.3.1; data were not located to support a different value from the default.
- AF for the quality of the whole database:
- 1
- Justification:
- A robust database exists for the substance. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.26 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 006 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 886 mg/kg was derived from a 13-week subchronic oral toxicity study with ammonium sulphate in F344 rats. This study was selected over a chronic bioassay in which a slight increase was observed in kidney weights and chronic progressive nephropathy (in male rats without clear dose response) was reported at ammonium sulphate dietary doses of 1.5 and 3%. Chronic nephropathy in male rats is likely a degenerative response of limited relevance for humans, thus the true NOAEL is likely higher than 1.5%. In the 13-week study, diarrhoea was observed in male rats at a dietary level 3%, corresponding to 1792 mg/kg; the NOAEL was 1.5% (886 mg/kg). Although diarrhoea was not observed at any dose in the chronic bioassay, it was considered to be the key effect for deriving a DNEL. No changes in body weights, organ weights, haematological, serum biochemical or histopathological parameters were observed so the 13-week study NOAEL is a conservative estimate of systemic toxicity. Diarrhoea is likely a direct response of the change of isotonicity in intestinal tract contents. Sulphate anion may have reduced osmotic pressure in the intestinal lumen, causing a net water influx, resulting in osmotic diarrhoea. The starting point from the 13-week study was modified for the appropriate dose descriptors, i.e., molecular weight differences between ammonium sulphate and the notified substance (254/132 or 1.92), allometric scaling for rodent to worker respiration (1/0.38 m3/kg bw), and normal human to worker respiratory volume correction for light activity (6.7 m3/10 m3) per REACH guidance R.8.4.2. As described above, the expected systemic toxicity is likely to be of secondary importance compared to the local effects. Thus, the more conservative inhalation local, long term DNEL for sulphuric acid of 0.13 mg/m3 should be utilized for purposes of risk assessment.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is a conservative NOAEL from a 13-week dietary exposure study in rats. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Since the conversion of the starting point by the respiratory rate scaling factor between rats and humans was utilized (i.e., 1/0.38 m3/kg), no further assessment factor for allometric scaling is necessary for oral to inhalation route of exposure extrapolation per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 1
- Justification:
- No overt systemic toxicity was observed from clinical chemical, body or organ weight, or pathological endpoints in the key study. Diahhrea is likely a direct response of the change in isotonicity of intestinal tract contents. Unabsorbed or excessive sulphate anion may reduce the osmotic pressure in the intestinal lumen, causing a net water flow into the lumen, resulting in osmotic diarrhea. This is likely a local effect, associated with high local concentrations of sulphate anion in the luminal contents. Accordingly, an assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- A default factor of 5 for workers is appropriate according to REACH guidance in R.8.4.3.1; data were not located to support a different value from the default.
- AF for the quality of the whole database:
- 1
- Justification:
- A robust database exists for the substance . An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for remaining uncertainties:
- 2
- Justification:
- The observed adverse outcome in a 13-week dietary exposure study was limited to diarrhoea, an outcome likely associated with osmotic imbalance due to high exposure levels of the notified substance. While diarrhoea was not observed in a chronic bioassay with ammonium sulphate in either male or female F344 rats at the same dose levels, diarrhoea was considered to represent an adverse effect. Data were not available to assess the relationship of the key effect with exposure duration. Accordingly, an assessment factor of 2 is a conservative value for study duration per REACH guidance R8.4.3.2.1.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.26 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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:
- 0.065 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):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 482 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 886 mg/kg was derived from a 13-week subchronic oral toxicity study with ammonium sulphate in F344 rats. This study was selected over a chronic bioassay in which a slight increase was observed in kidney weights and chronic progressive nephropathy (in male rats without clear dose response) was reported at ammonium sulphate dietary doses of 1.5 and 3%. Chronic nephropathy in male rats is likely a degenerative response of limited relevance for humans, thus the true NOAEL is likely higher than 1.5%. In the 13-week study, diarrhoea was observed in male rats at a dietary level 3%, corresponding to 1792 mg/kg; the NOAEL was 1.5% (886 mg/kg). Although diarrhoea was not observed at any dose in the chronic bioassay, it was considered to be the key effect for deriving a DNEL. No changes in body weights, organ weights, haematological, serum biochemical or histopathological parameters were observed so the 13-week study NOAEL is a conservative estimate of systemic toxicity. Diarrhoea is likely a direct response of the change of isotonicity in intestinal tract contents. Sulphate anion may have reduced osmotic pressure in the intestinal lumen, causing a net water influx, resulting in osmotic diarrhoea. The starting point from the 13-week study was modified for the appropriate dose descriptors, i.e., molecular weight differences between ammonium sulphate and the notified substance (254/132 or 1.92), allometric scaling for rodent to general population respiration (1/1.15 m3/kg bw), and normal human to worker respiratory volume correction for light activity (6.7 m3/10 m3) per REACH guidance R.8.4.2. As described above, the expected systemic toxicity is likely to be of secondary importance compared to the local effects. Thus, the more conservative inhalation local, long term DNEL for sulphuric acid of 0.13 mg/m3 should be utilized for purposes of risk assessment.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is a conservative NOAEL from a 13-week dietary exposure study in rats. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for differences in duration of exposure:
- 2
- Justification:
- The observed adverse outcome in a 13-week dietary exposure study was limited to diarrhoea, an outcome likely associated with osmotic imbalance due to high exposure levels of the notified substance. While diarrhoea was not observed in a chronic bioassay with ammonium sulphate in either male or female F344 rats at the same dose levels, diarrhoea was considered to represent an adverse effect. Data were not available to assess the relationship of the key effect with exposure duration. Accordingly, an assessment factor of 2 is a conservative value for study duration per REACH guidance R8.4.3.2.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Since the conversion of the starting point by the respiratory rate scaling factor between rats and humans was utilized (i.e., 1/1.15 m3/kg), no further assessment factor for allometric scaling is necessary for oral to inhalation route of exposure extrapolation per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 1
- Justification:
- No overt systemic toxicity was observed from clinical chemical, body or organ weight, or pathological endpoints in the key study. Diarrhoea is likely a direct response of the change in isotonicity of intestinal tract contents. Unabsorbed or excessive sulphate anion may reduce the osmotic pressure in the intestinal lumen, causing a net water flow into the lumen, resulting in osmotic diarrhoea. This is likely a local effect, associated with high local concentrations of sulphate anion in the luminal contents. Accordingly, an assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 10
- Justification:
- A default factor of 10 is appropriate for the general population according to REACH guidance in R.8.4.3.1; data were not located to support a different value from the default.
- AF for the quality of the whole database:
- 1
- Justification:
- A robust database exists for the substance . An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 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):
- 20
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 482 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 886 mg/kg was derived from a 13-week subchronic oral toxicity study with ammonium sulphate in F344 rats. This study was selected over a chronic bioassay in which a slight increase was observed in kidney weights and chronic progressive nephropathy (in male rats without clear dose response) was reported at ammonium sulphate dietary doses of 1.5 and 3%. Chronic nephropathy in male rats is likely a degenerative response of limited relevance for humans, thus the true NOAEL is likely higher than 1.5%. In the 13-week study, diarrhoea was observed in male rats at a dietary level 3%, corresponding to 1792 mg/kg; the NOAEL was 1.5% (886 mg/kg). Although diarrhoea was not observed at any dose in the chronic bioassay, it was considered to be the key effect for deriving a DNEL. No changes in body weights, organ weights, haematological, serum biochemical or histopathological parameters were observed so the 13-week study NOAEL is a conservative estimate of systemic toxicity. Diarrhoea is likely a direct response of the change of isotonicity in intestinal tract contents. Sulphate anion may have reduced osmotic pressure in the intestinal lumen, causing a net water influx, resulting in osmotic diarrhoea. The starting point from the 13-week study was modified for the appropriate dose descriptors, i.e., molecular weight differences between ammonium sulphate and the notified substance (254/132 or 1.92), allometric scaling for rodent to general population respiration (1/1.15 m3/kg bw), and normal human to worker respiratory volume correction for light activity (6.7 m3/10 m3) per REACH guidance R.8.4.2. As described above, the expected systemic toxicity is likely to be of secondary importance compared to the local effects. Thus, the more conservative inhalation local, long term DNEL for sulphuric acid of 0.13 mg/m3 should be utilized for purposes of risk assessment.
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor is a conservative NOAEL from a 13-week dietary exposure study in rats. An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Since the conversion of the starting point by the respiratory rate scaling factor between rats and humans was utilized (i.e., 1/1.15 m3/kg), no further assessment factor for allometric scaling is necessary for oral to inhalation route of exposure extrapolation per REACH guidance R.8.4.3.1.
- AF for other interspecies differences:
- 1
- Justification:
- No overt systemic toxicity was observed from clinical chemical, body or organ weight, or pathological endpoints in the key study. Diarrhoea is likely a direct response of the change in isotonicity of intestinal tract contents. Unabsorbed or excessive sulphate anion may reduce the osmotic pressure in the intestinal lumen, causing a net water flow into the lumen, resulting in osmotic diarrhoea. This is likely a local effect, associated with high local concentrations of sulphate anion in the luminal contents. Accordingly, an assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for intraspecies differences:
- 10
- Justification:
- A default factor of 10 is appropriate for the general population according to REACH guidance in R.8.4.3.1; data were not located to support a different value from the default.
- AF for the quality of the whole database:
- 1
- Justification:
- A robust database exists for the substance . An assessment factor of 1 is appropriate per REACH guidance R.8.4.3.1.
- AF for remaining uncertainties:
- 2
- Justification:
- The observed adverse outcome in a 13-week dietary exposure study was limited to diarrhoea, an outcome likely associated with osmotic imbalance due to high exposure levels of the notified substance. While diarrhoea was not observed in a chronic bioassay with ammonium sulphate in either male or female F344 rats at the same dose levels, diarrhoea was considered to represent an adverse effect. Data were not available to assess the relationship of the key effect with exposure duration. Accordingly, an assessment factor of 2 is a conservative value for study duration per REACH guidance R8.4.3.2.1.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.065 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
Acute/short term exposure
- Hazard assessment conclusion:
- other toxicological threshold
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- high 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.
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