Reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.25 mg/m³

DNEL related information

DNEL derivation method:

other: In accordance with ECHA REACH TGD R.8, 8.7.1. and ECETOC TR110 (2010), generally accepted OEL derived for inert (nuisance) dust/Particulates Not Otherwise Classified (PNOC) used as DNEL surrogate.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2.5 mg/m³

DNEL related information

DNEL derivation method:

other: In accordance with ECHA REACH TGD R.8, 8.7.1. and ECETOC TR110 (2010), generally accepted OEL derived for inert (nuisance) dust/Particulates Not Otherwise Classified (PNOC) used as DNEL surrogate.

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.25 mg/m³

DNEL related information

DNEL derivation method:

other: In accordance with ECHA REACH TGD R.8, 8.7.1. and ECETOC TR110 (2010), generally accepted OEL derived for inert (nuisance) dust/Particulates Not Otherwise Classified (PNOC) used as DNEL surrogate.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2.5 mg/m³

DNEL related information

DNEL derivation method:

other: In accordance with ECHA REACH TGD R.8, 8.7.1. and ECETOC TR110 (2010), generally accepted OEL derived for inert (nuisance) dust/Particulates Not Otherwise Classified (PNOC) used as DNEL surrogate.

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:

low hazard (no threshold derived)

Additional information - workers

Inhalative exposure:

As substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" is an inorganic, sparingly soluble crystalline solid of lamellar structure, systemic absorption and subsequent systemic activity via the inhalative route is highly unlikely. Even for the oral route, as seen in a 28-day limit dose test, there is no evidence of absorption and no evidence of toxicity. Nonetheless, although no substance specific intrinsic inhalative 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 approach to use general dust limits as DNEL surrogate for inert dusts is in line with ECHA REACH TGD R.8, 8.7.1. and ECETOC TR110 (2010). As the particle size distribution data indicate on respirable fractions (4.3% of total dustiness fraction, respectively 0.51% of total substance mass in consideration the total dustiness fraction of 119.32 mg/g), OELs derived for chronic and acute exposure to alveolar (respirable) dust were selected as DNEL surrogates for inhalative systemic as well as local effects. 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 addition, the DNEL long-term inhalation was calculated in accordance with the very conservative assumptions and AFs indicated in ECHA REACH TDG R.8: Based on the highest non-toxic dose by oral exposure (limit dose of 1000 mg/kg bw/day was without any effects in a reliable, adequate and relevant 28-day study) and applying standard default values for workers‘ body weight (70 kg), respiratory volume per shift (10 m³), absorption via oral route (50 %) and absorption via inhalation (100 %), the resulting route-to-route extrapolated NOAEL inhalative is 882 mg/m³. The following AF default values apply according to ECHA REACH TDG R.8: (route-to-route: 2 (already included in calculated starting point inhalation)), allometric scaling 4 (rats to humans), additional uncertainty: 2.5, intraspecies (worker): 5, exposure duration (sub-acute to chronic): 6, dose-response: 1, quality of data: 1. The resulting overall AF is 300 and the calculated corresponding DNEL long-term, worker 2.94 mg/m³, which is in the range of the general dust limit of 1.25 to 5 mg/m³ for alveolar (respirable dust) enacted in European countries. Considering the high level of conservatism in applied default assumptions and AFs - e. g., default assumption of 100 % resorption via the inhalative route, although it is generally accepted that inert dusts are almost non bioavailable; the use of AF for additional uncertainty of 2.5, although the remaining uncertainty for interspecies variability is already accounted for by the intraspecies (c. f. ECETOC TR 110, 3.2.6) and use of AF for intraspecies (worker) of 5 instead of 3, which is the more realistic AF based on evaluation of scientific literature (c. f. ECETOC TR 110, 3.2.4), the slight difference between calculated DNEL and the lowest European standard dust limit values selected as DNEL surrogates is not considered relevant in respect to human safety. Already the use of the AFs “additional uncertainty for interspecies variability” and “intraspecies (worker)” recommended in ECETOC TR 110, will lower the total AF to 72 and thus increase the calculated DNEL to 12.25 mg/m³. This value is even higher than the general dust limit for inhalable dust. Therefore, the use of general dust limits for respirable dust is expected to be a conservative approach ensuring a high level of safety.

 

Dermal exposure:

Considering the missing toxicity in acute and repeated dose toxicity studies by oral route, the negligible dermal absorption of an inorganic, sparingly soluble, crystalline solid of lamellar structure and the missing dermal toxicity in acute LD50 and irritation studies, an intrinsic systemic or local toxicity by dermal exposure is highly unlikely. Therefore, no dermal DNELs were derived.

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:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

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:

no hazard identified

Additional information - General Population

In service life, substance "reaction mass of calcium hydrogen phosphonate and dialuminium tricalcium hexaoxide" is embedded in polymer matrices. As there is no release from these polymer matrices during service life, the general population will not be exposed to the substance and derivation of DNELs general population is not necessary.