Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Justification for read-across: a full read-across additional report concerning extrapolation from sodium perchlorate to ammonium perchlorate for genotoxicity endpoint is attached in IUCLID section 13 (CEHTRA 2015).

Ammonium perchlorate was negative in a bacterial gene mutation assay, conducted at the maximal recommended concentration, with and without metabolic activation.

Ammonium perchlorate was negative in a total of three in vivo micronucleus assays, two of which are summarized:

- at up to 1000 mg/kg/day by oral gavage x three days in mice (key study: lethality at 2000 mg/kg once): Sharma 1998

- at up to 500 mg/kg/day by i.p. injection x three days in mice (supportive study: no report; personal communication between Errol Zeiger and EPA; lethality at 1000 mg/kg twice)

- at up to 10 mg/kg/day in drinking water x 90 days in rats (supportive: non-standard, dose too low): Siglin 1998

The read-across analogue substance sodium perchlorate was negative in an in vitro Mouse Lymphoma Assay with and without metabolic activation, up to 5000 µg/mL.


Justification for selection of genetic toxicity endpoint
Several in vitro/in vivo studies were used to complete this endpoint therefore no specific study could be selected.

Short description of key information:
Ammonium perchlorate was negative in a bacterial gene mutation assay, conducted at the maximal recommended concentration.
Ammonium perchlorate was negative in a total of three in vivo micronucleus assays.
The read-across analogue substance sodium perchlorate was negative in an in vitro Mouse Lymphoma Assay with and without metabolic activation, up to 5000 µg/mL.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the existence of a negative Ames test, three negative independent in vivo micronucleus assays (including two with maximized top-dose based on lethality) and a negative in vitro Mouse Lymphoma Assay on the read-across analogue substance sodium perchlorate, it was considered that ammonium perchlorate is clearly non-genotoxic (neither mutagenic nor clastogenic).

Considering these data, classification of ammonium perchlorate as mutagenic can be excluded.