Reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide

Carcinogenicity

Description of key information

Based on toxicological as well as exposure considerations substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" is not expected to cause carcinogenic effects. 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records

Reference

Endpoint:

carcinogenicity, other

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

carcinogenicity, other

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via dermal route

Link to relevant study records

Reference

Endpoint:

carcinogenicity, other

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on toxicological as well as exposure considerations substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" is not expected to cause carcinogenic effects.

In accordance with CLP Regulation (EC) No 1272/2008, substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" is not is not classified for carcinogenicity and labelling is not required.

Additional information

Carcinogenicity data is not a data requirement at the registered tonnage band. Furthermore, according to REACH Regulation, Annex X, column 2, carcinogenicity study is not required as the substance is not expected to have a widespread dispersive use and the use of the substance as such is restricted to production sites only. Moreover substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" is not classified as mutagen. The mutagenic and clastogenic potential of the substance has been evaluated in the full range of in vitro studies and in a single in vivo genotoxicity study. There was no evidence for genotoxic properties of the substance. From repeated dose toxicity data, there is no evidence that the substance may induce hyperplasia and pre-neoplastic lesions (subacute NOEL oral: 1000 mg/kg bw/day). Thus, although carcinogenicity studies are not available for substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide", available data on genotoxicity and repeated dose toxicity do not raise any specific concerns regarding carcinogenicity.

In addition, as the substance is an inorganic, crystalline sparingly soluble solid of lamellar structure, systemic absorption and subsequent systemic activity via the dermal or inhalative route is highly unlikely. Oral exposure at industrial sites is unlikely and the substance is not directly accessible to the general population, as it is embedded in polymer matrices in service life. Inhaled and subsequently swallowed amounts are not expected to be bioavailable as such. Thus, the substance as such is not expected to be bioavailable to reach the systemic circulation or target organs. The substance may decompose under the strong acidic conditions of the stomach and the released ions may become bioavailable. However, even under worst case considerations systemic effects deriving from the released ions are highly unlikely and substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" respectively its dissolved ionic moieties are not expected to cause carcinogenic effects (c.f. CSR section 5.1.3 or Technical dossier section 7.1). Nonetheless, although no substance specific intrinsic toxicity is expected, generally accepted OELs derived for inert (nuisance) dust/Particulates Not Otherwise Classified (PNOCs) are applicable and must be adhered to, to avoid unspecific inhalative dust toxicity. The general dust limits are not harmonised within Europe. For chronic exposure to alveolar (respirable) dust, values in the range from 1.25 to 5 mg/m³ have been enacted in European countries. Germany has enacted the lowest values (1.25 mg/m³ for chronic and of 2.5 mg/m³ for acute exposure, Technische Regeln für Gefahrstoffe (TRGS) 900, v. 08.08.2019), which were selected as DNEL surrogate in compliance with ECHA REACH TGD R.8. Thus, at the production site, and occupational downstream users, the exposure to dusts/aerosols can be assumed as insignificant due to personal protective and engineering RMMs standardly implemented to comply with the general dust OELs. By adherence to the general dust limits, the risk to workers can be considered to be sufficiently controlled. Further on, in service life, the substance is embedded in polymer matrices. As there is no release from these polymer matrices during the service life stages, the general population is not exposed to the substance. Therefore, a carcinogenicity study is not necessary for substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide".