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Registration Dossier
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EC number: 231-900-3 | CAS number: 7778-18-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.17 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 7.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 158.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that the oral intake of up to 1062 mg/person/day (which is equal to 15.2 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 15.2 mg/kg bw/day can be regarded as NOAEL for long-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 158.8 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (8h work shift), human bodyweight (70 kg) and breathing volume (20 m³/24h).
- AF for interspecies differences (allometric scaling):
- 1.5
- Justification:
- Assessment factor for correction of worker breathing volume correction
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 082 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 7.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 38 115 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that, assuming a worst case scenario, the one-time oral intake of up to 8000 mg/person/day (which is equal to 114 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 114 mg/kg bw/day can be regarded as NOAEL for short-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 38113 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (15 min), human bodyweight (70 kg) and breathing volume (20 m³/24h).
- AF for interspecies differences (allometric scaling):
- 1.5
- Justification:
- Assessment factor for correction of worker breathing volume correction
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
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:
- no hazard identified
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:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.29 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that the oral intake of up to 1062 mg/person/day (which is equal to 15.2 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 15.2 mg/kg bw/day can be regarded as NOAEL for long-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 52.9 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (24h), human bodyweight (70 kg) and breathing volume (20 m³/24h).
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 811 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 38 113 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that, assuming a worst case scenario, the one-time oral intake of up to 8000 mg/person/day (which is equal to 114 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 114 mg/kg bw/day can be regarded as NOAEL for short-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 38113 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (15 min), human bodyweight (70 kg) and breathing volume (20 m³/24h).
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
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:
- no hazard identified
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:
- 1.52 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that the oral intake of up to 1062 mg/person/day (which is equal to 15.2 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 15.2 mg/kg bw/day can be regarded as NOAEL for long-term oral uptake.
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.4 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 114 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that, assuming a worst case scenario, the one-time oral intake of up to 8000 mg/person/day (which is equal to 114 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 114 mg/kg bw/day can be regarded as NOAEL for short-term oral uptake.
- AF for intraspecies differences:
- 10
- Justification:
- Default for general population
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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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