Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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