Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 914-103-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.68 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
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:
- 10.24 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
In general, the calculation of a DNEL is based on the observed effect level which has to be modified as described in “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, May 2008).
For calculation of the DNEL for long-term dermal systemic effects the No-(Adverse) -Effect-Level for oral repeated-dose toxicity of ammonium sulphate was used, which was obtained in a 52 and 104 weeks feeding study in rats (Ota et al., 2006). Based on the increased kidney weights, the decreased absolute spleen weights and the increased relative liver weights a NOAEL of 256 mg/kg bw/d for males and 284 mg/kg bw/d for females was determined. For calculation of DNELs, the more sensitive NOAEL of 256 mg/kg bw/d was used.
Since the NOAEL was obtained in an oral toxicity study, the dose descriptor has to be converted into a corrected starting point by route-to-route extrapolation. The dermal absorption was assumed to be 50% of the oral route. Thus, the corrected starting point was calculated as 512 mg/kg bw/d for dermal exposure.
The DNEL for dermal exposure was calculated using the corrected starting point of 512 mg/kg bw/day / overall assessment factor (50) = 10.24 mg/kg bw/day.
For calculation of the DNEL for long-term inhalative systemic effects the No-(Adverse) -Effect-Level for inhalative repeated-dose toxicity of ammonium sulphate was used. The calculation was based on a 14-day inhalation study in rats exposed to ammonium sulphate at the only tested dose of 300 mg/m³ for 8 hours per day (Pepelko et al., 1980). Due to absence of histopathological changes in the respiratory tract as well as no changes in pulmonary function and arterial blood gases a NOAEC of 300 mg/m³ was determined.
The conversion of the inhalatory rat NOAEC into a corrected inhalatory human NAEC was based on the different respiratory rate during light activity at work (10 m³) and standard conditions for rats (6.7 m³). Based on the daily exposure of 8 hours in the animal study, a correction for a different exposure duration of workers was not necessary.
NAEC = 300 mg/m³ * 6.7m³ (8h) / 10m³ (8h) = corrected NAEC of 201.0 mg/m³.
The DNEL for inhalative exposure was calculated using the corrected NAEC 201.0 mg/m³ / overall assessment factor (75) = 2.68 mg/m³.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.667 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
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:
- 5.12 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.56 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
For calculation of the DNEL for long-term oral systemic effects the No-(Adverse) -Effect-Level for oral repeated-dose toxicity of ammonium sulphate was used, which was obtained in a 52 and 104 weeks feeding study in rats (Ota et al., 2006). Based on the increased kidney weights, the decreased absolute spleen weights and the increased relative liver weights a NOAEL of 256 mg/kg bw/d for males and 284 mg/kg bw/d for females was determined. For calculation of DNEL, the NOAEL of 256 mg/kg bw/d was used.
The DNEL for oral exposure was calculated using the starting point of 256 mg/kg bw/d/day / overall assessment factor (100) = 2.56 mg/kg bw/d.
For calculation of the DNEL for long-term dermal systemic effects the No-(Adverse) -Effect-Level for oral repeated-dose toxicity of ammonium sulphate was used, which was obtained in a 52 and 104 weeks feeding study in rats (Ota et al., 2006). Based on the increased kidney weights, the decreased absolute spleen weights and the increased relative liver weights a NOAEL of 256 mg/kg bw/d for males and 284 mg/kg bw/d for females was determined. For calculation of DNEL, the NOAEL of 256 mg/kg bw/d was used.
Since the NOAEL was obtained in an oral toxicity study, the dose descriptor needs to be converted into a corrected starting point by route-to-route extrapolation. The dermal absorption was assumed to be 50% of the oral route. Thus, the corrected starting point was calculated as 512 mg/kg bw/d for dermal exposure.
The DNEL for dermal exposure was calculated using the corrected starting point of 512 mg/kg bw/d/day / overall assessment factor (100) = 5.12 mg/kg bw/d.
For calculation of the DNEL for long-term inhalative systemic effects the No-(Adverse) -Effect-Level for inhalative repeated-dose toxicity of ammonium sulphate was used. The calculation was based on a 14-day inhalation study on rats exposed to ammonium sulphate at the only tested dose of 300 mg/m³ for 8 hours per day (Pepelko et al., 1980). Due to non-histopathological changes in the respiratory tract as well as no changes in pulmonary function and arterial blood gases a NOAEC of 300 mg/m³.
For conversion of the inhalatory rat NOAEC into a corrected inhalatory human NAEC, the difference in exposure length as to be taken into account. Thus, the corrected NAEC is calculated as 300 mg/m³ x 24 h / 8 h = of 100.0 mg/m³.
The DNEL for inhalative exposure was calculated using the corrected NAEC 100.0m³ / overall assessment factor (150) = 0.667 mg/m³.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
