Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No data for toxicity to reproduction 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, fertility studies are available on sodium fluoride as analogue of calcium fluoride, calcium sulfate or calcium carbonate.


Based on a weight of evidence approach using the information on its constituents, no classification of the registered substance is warranted for the toxicty to reproduction according to the criteria of CLP.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat

Effects on developmental toxicity

Description of key information

No data for developmental toxicity/teratogenicity 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, developmental studies are available on sodium fluoride (as surrogate of calcium fluoride), calcium sulfate or calcium carbonate as described below. Based on a weight of evidence approach using the information on its constituents, no classification of the registered substance is warranted for the developmental toxicty according to the criteria of CLP.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subchronic
Species:
rat

Toxicity to reproduction: other studies

Description of key information

No data

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 toxicity to reproduction (fertility and development) 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).

Additional information