Registration Dossier

Administrative data

Workers - 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:
DNEL (Derived No Effect Level)
Value:
2 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.2 mg/m³
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:
high hazard (no threshold derived)

Additional information - workers

The DNELs for local inhalation effects are based on the corresponding DNELs that are available for hydrogen peroxide, taking into account that:

a) according to the stoichiometry of the hydrolysis reaction of calcium peroxide, an equimolar amount of hydrogen peroxide is formed; and that

b) the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide typically contains 75% of calcium peroxide.

 

Worker – inhalation – local effects – long term

 

DNEL (hydrogen peroxide):          1.4 mg/m3

 

a) stoichiometrie

 

1.4 mg hydrogen peroxide             = 4.116E-05 mol hydrogen peroxide

                                                       = 4.116E-05 mol calcium peroxide

 

4.116E-05 mol calcium peroxide   = 3.0 mg calcium peroxide

 

DNEL (calcium peroxide)              = 3.0 mg/m3

 

b) composition of reaction mass

 

DNEL (calcium peroxide)              = 3.0 mg/m3

DNEL (reaction mass)                    = 4.0 mg/m3

 

As synergistic effects between hydrogen peroxide and calcium dihydroxide cannot be excluded (both have local effects), an extra assessment factor of 2 is taken into account.

 

The final DNEL for the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide therefore is:

 

DNEL (reaction mass)                    = 2.0 mg/m3

 

 

Worker – inhalation – local effects – short term

 

DNEL (hydrogen peroxide):           3.0 mg/m3

 

a) stoichiometrie

 

3.0 mg hydrogen peroxide             = 8.821E-05 mol hydrogen peroxide

                                                        = 8.821E-05 mol calcium peroxide

 

8.821E-05 mol calcium peroxide    = 6.36 mg calcium peroxide

 

DNEL (calcium peroxide)               = 6.36 mg/m3

 

b) composition of reaction mass

 

DNEL (calcium peroxide)               = 6.36 mg/m3

DNEL (reaction mass)                     = 8.48 mg/m3

 

As synergestic effects between hydrogen peroxide and calcium dihydroxide cannot be excluded, an extra assessment factor of 2 is taken into account.

                   

The final DNEL for the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide therefore is:

 

DNEL (reaction mass)                     = 4.2 mg/m3

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:
DNEL (Derived No Effect Level)
Value:
0.3 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.7 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
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:
high hazard (no threshold derived)

Additional information - General Population

The DNELs for local inhalation effects are based on the corresponding DNELs that are available for hydrogen peroxide, taking into account that:

a) according to the stoichiometry of the hydrolysis reaction of calcium peroxide, an equimolar amount of hydrogen peroxide is formed; and that

b) the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide typically contains 75% of calcium peroxide.

 

 

General population – inhalation – local effects – long term

 

DNEL (hydrogen peroxide):          0.21 mg/m3

 

a) stoichiometrie

 

0.21 mg hydrogen peroxide            = 6.174E-06 mol hydrogen peroxide

                                                        = 6.174E-06 mol calcium peroxide

 

6.174E-06 mol calcium peroxide    = 0.44 mg calcium peroxide

 

DNEL (calcium peroxide)                = 0.44 mg/m3

 

b) composition of reaction mass

 

DNEL (calcium peroxide)                = 0.44 mg/m3

DNEL (reaction mass)                      = 0.59 mg/m3

 

As synergestic effects between hydrogen peroxide and calcium dihydroxide cannot be excluded, an extra assessment factor of 2 is taken into account.

 

The final DNEL for the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide therefore is:

 

DNEL (reaction mass)                      = 0.3 mg/m3

 

 

General population – inhalation – local effects – short term

 

DNEL (hydrogen peroxide):             1.93 mg/m3

 

a) stoichiometrie

 

3.0 mg hydrogen peroxide             = 5.6748E-05 mol hydrogen peroxide

                                                          = 5.6748E-05 mol calcium peroxide

 

5.6748E-05 mol calcium peroxide = 4.09 mg calcium peroxide

 

DNEL (calcium peroxide)                 = 4.09 mg/m3

 

b) composition of reaction mass

 

DNEL (calcium peroxide)                 = 4.09 mg/m3

DNEL (reaction mass)                      = 5.45 mg/m3

 

As synergistic effects between hydrogen peroxide and calcium dihydroxide cannot be excluded (both substances have local effects), an extra assessment factor of 2 is taken into account.

 

The final DNEL for the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide therefore is:

 

DNEL (reaction mass)                      = 2.7 mg/m3