Registration Dossier

Reference

Endpoint:: extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:: other justification
Justification for data waiving:: other:
Reproductive effects observed:: not specified

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

According to REACH Regulation, standard information requirement 8.7, column 2, reproductive toxicity, respective studies are not required, if the substance is of low toxicological activity, no systemic absorption occurs via relevant routes of exposure and there is no significant human exposure. There is no evidence for intrinsic toxic properties of substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" relevant to humans obtained from the results of a reliable, adequate and relevant repeated dose oral toxicity study on rats. The tested dose range includes the guideline limit dose of repeated dose toxicity studies. Up to and including the highest dose tested of 1000 mg/kg bw/day, no mortality occurred and there were no changes in clinical appearance, body weights, food consumption, ophthalmoscopic examination, clinical laboratory investigations, macroscopic examinations, organ weights and microscopic examination, which also covered the reproductive organs, that were considered to be an adverse effect of treatment. 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, cross the placental, blood-brain or blood-testes barriers, or to be secreted in milk. 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 impair the fertility (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. Thus, in accordance with REACH Regulation, Annex VIII ff., standard information requirement 8.7, column 2, studies on reproductive toxicity are not justified due to exposure as well as toxicological considerations.

Short 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 impair the fertility.

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

Reference

Endpoint:: developmental toxicity
Data waiving:: other justification
Justification for data waiving:: other:
Abnormalities:: not specified
Developmental effects observed:: not specified

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

According to REACH Regulation, standard information requirement 8.7, column 2, reproductive toxicity, respective studies are not required, if the substance is of low toxicological activity, no systemic absorption occurs via relevant routes of exposure and there is no significant human exposure. There is no evidence for intrinsic toxic properties of substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" relevant to humans obtained from the results of a reliable, adequate and relevant repeated dose oral toxicity study on rats. The tested dose range includes the guideline limit dose of repeated dose toxicity studies. Up to and including the highest dose tested of 1000 mg/kg bw/day, no mortality occurred and there were no changes in clinical appearance, body weights, food consumption, ophthalmoscopic examination, clinical laboratory investigations, macroscopic examinations, organ weights and microscopic examination, which also covered the reproductive organs, that were considered to be an adverse effect of treatment. 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, cross the placental, blood-brain or blood-testes barriers, or to be secreted in milk. 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 impair the fertility (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. Thus, in accordance with REACH Regulation, Annex VIII ff., standard information requirement 8.7, column 2, studies on reproductive toxicity are not justified due to exposure as well as toxicological considerations.

Short 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 be a developmental toxicant.

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

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