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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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