Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

10 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

Modified dose descriptor starting point:

NOAEC

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

10 mg/m³

DNEL related information

Modified dose descriptor starting point:

NOAEC

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

10 mg/m³

Acute/short term exposure

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure

DNEL related information

Additional information - workers

The registered substance is Aluminium calcium oxide sulfate (Ettringite (anhydrous)): CAS number 12004 -14 -7. So far Ettringite (anhydrous) does not exist physically. Only the hydrous form Ettringite is the existing substance (CAS number 12252-12-9 (Ettringite (Ca₆Al₂[(OH)₁₂/(SO₄)₃]^.26 H₂O). It is a naturally occuring mineral but also produced by anorganic synthesis. Its an inorganic cristalline substance and according to its sum formula existing of Al³⁺, Ca²⁺, OH^-und SO₄^2--Ions. The final allocation of the ions in a crystalline structure depends strongly on the pH: only in a very alkaline environment a crystallographic homogenous structure is formed: Ettringite. In an environment of neutral pH as in the body fluids calcium sulfate and aluminium hydroxide will separate to some extend. Under this conditions the solubility of aluminium hydroxide is very low and it will precipitate in an amorphous form. Only gypsum (CaSO₄^.2H₂O) is to some extent soluble at neutral pH.

This is demonstrated by the physical-chemical (analytical) studies. Therefore the biological and especially the toxicological properties of Ettringite are assessed by its content of gypsum (

CaSO₄^.2H₂O) /calcium sulfate (dihydrate).

Where studies allow a comparison the results with Ettringite are the same as those with calcium sulfate. Therefore the toxicological properties of Ettringite can be derived from the studies with calcium sulfate. See further data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13). Here no correction factor for differences in molecular weights between CaSO₄and Ettringite (anhydrous) was used for the derivation of the DNELs. Via this an additional safety factor of about 5 is included.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

5 mg/m³

DNEL related information

Overall assessment factor (AF):

2

Modified dose descriptor starting point:

NOAEC

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

5 mg/m³

DNEL related information

Overall assessment factor (AF):

2

Modified dose descriptor starting point:

NOAEC

Local effects

Long term exposure

Hazard assessment conclusion:

no-threshold effect and/or no dose-response information available

Acute/short term exposure

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

15.2 mg/kg bw/day

DNEL related information

Modified dose descriptor starting point:

NOAEL

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

114 mg/kg bw/day

DNEL related information

Modified dose descriptor starting point:

NOAEL

Additional information - General Population

The registered substance is Aluminium calcium oxide sulfate (Ettringite (anhydrous)): CAS number 12004 -14 -7. So far Ettringite (anhydrous) does not exist physically. Only the hydrous form Ettringite is the existing substance (CAS number 12252-12-9 (Ettringite (Ca₆Al₂[(OH)₁₂/(SO₄)₃]^.26 H₂O). Its a naturally occuring mineral but also produced by anorganic synthesis. Its an inorganic cristalline substance and according to its sum formula existing of Al³⁺, Ca²⁺, OH^-und SO₄^2--Ions. The final allocation of the ions in a crystalline structure depends strongly on the pH: only in a very alkaline environment a crystallographic homogenous structure is formed: Ettringite. In an environment of neutral pH as in the body fluids calcium sulfate and aluminium hydroxide will separate to some extend. Under this conditions the solubility of aluminium hydroxide is very low and it will precipitate in an amorphous form. Only gypsum (CaSO₄^.2H₂O) is to some extent soluble at neutral pH.

This is demonstrated by the physical-chemical (analytical) studies. Therefore the biological and especially the toxicological properties of Ettringite are assessed by its content of gypsum

(CaSO₄^.2H₂O) /calcium sulfate (dihydrate).

Where studies allow a comparison the results with Ettringite are the same as those with calcium sulfate. Therefore the toxicological properties of Ettringite can be derived from the studies with calcium sulfate. See further data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13). Here no correction factor for differences in molecular weights between CaSO₄ and Ettringite (anhydrous) was used for the derivation of the DNELs. Via this an additional safety factor of about 5 is included.