Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 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:
69.65 mg/m³
Explanation for the modification of the dose descriptor starting point:
systemic effects observed
AF for dose response relationship:
1
Justification:
ECHA Guidance
AF for differences in duration of exposure:
2
Justification:
secondary evaluations (EFSA/JECFA) concluding that Ca sulfate is a non-toxic food a
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
human experience with Ca sulfate as food additive
AF for intraspecies differences:
5
Justification:
ECHA Guidance
AF for the quality of the whole database:
1
Justification:
ECHA Guidance
AF for remaining uncertainties:
1
Justification:
ECHA Guidance
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
395 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAEL for systemic effects in oral study: 79 mg/kg/d, adjustment for differences in absorption (oral 50%, dermal 10%)
AF for dose response relationship:
1
Justification:
ECHA Guidance
AF for differences in duration of exposure:
2
Justification:
secondary evaluations (EFSA/JECFA) concluding that Ca sulfate is a non-toxic food additive / long-term use experience as food additive
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
human experience with Ca sulfate as food additive
AF for intraspecies differences:
5
Justification:
ECHA Guidance
AF for the quality of the whole database:
1
Justification:
ECHA Guidance
AF for remaining uncertainties:
1
Justification:
ECHA Guidance
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:
medium hazard (no threshold derived)

Additional information - workers

DNEL derivation is based on the lowest NOAEL for any of the key components. A NOAEL of 79 mg/kg bw/day was derived from an OECD 422 guideline study with Ca sulfate, which constitutes about 50% of the submission substance. The NOAEL for repeated dose toxicity for phosphate is 250 mg/kg bw/day. In a conservative approach the NOAEL from the Ca sulfate study was taken as NOAEL for the submission substanc.

Starting points for DNEL derivation after route-to-route extrapolation were corrected for differences in absorption:

The following absorption fractions were assumed: oral 50%, inhalation 100%, dermal 10%.

For both Ca sulfate and phosphate evalutions by EFSA and JECFA confirm their low toxiicty and ample long-term experience exist with its occurrence in food. Ca sulfate is an approved food additive. Therefore no additional assessment factor for differences between species is considered necessary and a factor of 2 for extrapolation to chronic exposure situations is considered sufficient.

General Population - Hazard via inhalation 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
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:
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:
no hazard identified

Additional information - General Population

No DNELs were derived for the general population as no consumer uses were identified