Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A two-generation study was conducted in rats exposed to ammonium perchlorate at 0, 0.3, 3 and 30 mg/kg/day.

Parental and offspring NOAEL were set at 0.3 mg/kg/day because of thyroid hypertrophy/hyperplasia. This effect was already identified in the 90 days study and the presence of the effect on the offspring is not a specific reproductive toxic effect.

Fertility NOAEL was set at 30 mg/kg/day as there was no effect on reproductive parameters at highest dose used in this study.

Perchloric acid, once absorbed in the general circulation is expected to be transformed into perchlorate moiety because of the blood buffering effect. Therefore the results of this study on ammonium perchlorate are used in a read across approach to evaluate perchloric acid reproductive toxicity.


Short description of key information:
- Perchloric acid reproductive toxicity evaluated by read-across with ammonium perchlorate.
- Rat thyroid hypertrophy/hyperplasia observed at the same dose-level on both parents and offspring with no specific toxicity on offsprings when treated orally with ammonium perchlorate.
- No effects observed on the reproductive parameters at the highest studied dose 30 mg/kg/day.

Effects on developmental toxicity

Description of key information
- Perchloric acid developmental toxicity evaluated by read-across with ammonium perchlorate.
- Thyroid hypertrophy/hyperplasia observed on rat dams when treated orally with ammonium perchlorate.
- No adverse effects observed on the rat litters at the highest studied dose 30 mg/kg/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Ammonium perchlorate was provided to groups of 24 female rats via drinking water, at dose-levels of 0 (control), 0.01, 0.1, 1 and 30 mg/kg/day before (2 weeks before mating, complete mating) and during gestation (21 days).

At 30 mg/kg/day, there was no maternal toxicity. Pre- and Post-implantation loss indices were higher than in controls but this was not considered to represent relevant resorptions when considering the number of resorptions, implantation sites, live and dead foetuses. There was a minor indication of delayed ossification (fewer ossification sites) but this effect is minimal, and not adverse: it represents a slight delay in development which is usually reversible. No developmental abnormalities were observed. At 0.01 to 1 mg/kg/day, neither maternal nor embryo-/foeto- or developmental toxicities were observed.

 

An additional 16 litters/group were sacrificed on DG 21 for thyroid histopathology and thyroid hormones measurement. As expected, effects on thyroid hormones and colloid depletion were observed in both dams and foetuses but are considered as adaptative and non adverse. However, thyroid follicular cells hypertrophy/hyperplasia was observed only for the dams at 30 mg/kg/day.

Therefore with a maternal NOAEL at 1.0 mg/kg-day and a developmental NOAEL at 30.0 mg/kg-day ammonium perchlorate is not a selective developmental toxicant. 

 

Perchloric acid, once absorbed in the general circulation is expected to be transformed into perchlorate moiety because of the blood buffering effect. Therefore the results of this study on ammonium perchlorate are used in a read across approach to evaluate perchloric acid developmental toxicity.

Justification for classification or non-classification

In the available reproductive and developmental studies on Ammonium perchlorate no specific effects on fertility or on development have been identified.

Based on these results Perchloric acid is not classified for fertility and developmental toxicity according to DSD 67/548/EC and to CLP 1272/2008/EC criteria.

Additional information