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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Description of key information

No data for repeated dose toxicity are available with the substance identified as reaction mass of calcium fluoride (ca 47.5% w/w), calcium sulfate (ca 22.3% w/w) and calcium carbonate (ca 12.09% w/w). However, sub-acute or sub-chronic studies by oral and/or by inhalation are available on sodium fluoride as analogue of calcium fluoride, calcium sulfate or calcium carbonate. No adverse effects have been observed for CaSO4 and CaCO3. For NaF (the source substance for CaF2) effects have been observed to the bones and teeth in a 2-year carcinogenicity study. The reported LOAEL is 1.2 mg/kg bw/d CaF2 which corresponds to an effect level of 2.4 mg/kg bw/d reaction mass when taking into consideration that there is about 50% CaF2 in the reaction mass.


Based on a weight of evidence approach using the information on its constituents, no classification as STOT RE is warranted for the registered substance according to the criteria of CLP based on evidence repeated dose toxicity studies in animal and epidemiological studies with the constituents.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LOAEL
2.4 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Reliable read across data based on sodium fluoride investigations.
System:
musculoskeletal system
Organ:
bone
tooth

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
399 mg/m³
Study duration:
subchronic
Species:
rat
Quality of whole database:
The NOAEC of the substance is based on the NOAEC of Calcium carbonate (nano) determined in a GLP 90-day repeated dose toxicity study conducted in rat exposed by inhalation

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
1 753 mg/m³
Study duration:
subchronic
Species:
rat
Quality of whole database:
The NOAEC of the substance is based on the NOAEC of Calcium carbonate (nano) determined in a GLP 90-day repeated dose toxicity study conducted in rat exposed by inhalation. The NOAEC is based on some local effects (signs of inflammation at the highest dose). Taking into account that CaCO3 is present for typically 12.09 % in the reaction mass, the NOAEC could be calculated as 1753 mg/m3.

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Harmonised classification

Reaction mass of calcium fluoride and calcium sulfate and calcium carbonate has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).

 

Self classification

Based on the available studies performed on its three main constituents, no additional classification is proposed regarding the repeated dose toxicity of the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).