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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
22 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:
220.4 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:
available long-term toxicity data on phosphate leading to higher NOAELs, secondary evaluations (JECFA) concluding that phosphate is a non-toxic food additive
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:
31 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:
1 250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAEL for systemic effects in oral study: 250 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:
available long-term toxicity data on phosphate leading to higher NOAELs, secondary evaluations (JECFA) concluding that phosphate 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 phosphate 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 the analogue substance TSP (triple super phosphate). A NOAEL of 250 mg/kg bw/day was derived from an OECD 422 guideline study.

A slightly lower NOAEL of 79 mg/kg bw/day was derived from another OECD 422 guideline study with

Ca sulfate, which constitutes only about 5% of the submission substance. Based on the low content of Ca sulfate and the similar NOAEL it is considered that the NOAEL derived from TSP is a suitable basis to derive DNELs.

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 toxicity and ample long-term experience exist with its occurrence in food. Both Ca sulfate and phosphate are approved food additives. 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 consumer uses identified