Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Although no studies were found on the potential impact of the ammonium salts of ATMP on fertility and reproduction, and on the potential impact of ammonium salts on fetal development, it is probable that this substance will ionize to the acid and respective counterion under physiological conditions (see Section 1.2 and Annex VI). Based on the read across data from the parent acid (ATMP) it is considered unlikely that the ATMP ammonium salt would impair fertility, or in the absence of maternal toxicity cause developmental effects.

 

The properties and role of ammonia present in solutions of this salt have been given due consideration. Ammonia has been evaluated in detail at EU level. In the harmonised hazard assessment aqueous ammonia is not classified for effects on fertility and reproduction. Therefore it is considered that ammonia in the substance contributes no additional hazard in respect of this endpoint.


Short description of key information:
There are no data on the ammonium salt of ATMP. However read across data from a key reliable three-generation reproductive toxicity feeding study in rats using nitrilotrimethylenetris(phosphonic acid) reported a general and reproductive toxicity NOAEL to be greater than the highest dose tested; (approximately equal to a dose of 275 mg/kg bw/day in males and 310 mg/kg bw/day for females). (Biodynamics Inc, 1979a)

Read across from a key reliable teratology study in rats using nitrilotrimethylenetris(phosphonic acid) reported a maternal NOAEL to be 500 mg/kg bw/day, and the NOAEL for fetotoxicity and teratogenicity to be >1000 mg/kg bw/day (Biodynamics Inc 1979b, rel 2).

Justification for classification or non-classification

Based on the read across data from ATMP and the fact that the presence of ammonia does not contribute any additional hazard, it is concluded that there is no requirement for classification.