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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

A guideline- and GLP-compliant 90-day rat toxicity study performed with the read-across substance ammonium perchlorate confirms the thyroids as the target organ for perchlorate, consistent with its known therapeutic mode of action.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
A guideline- and GLP-compliant 90-day rat toxicity study is available with the read-across substance ammonium perchlorate.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A 90-day drinking water performed in rats with ammonium perchlorate at dose levels of up to 10 mg/kg bw/d identified effects of TSH levels (increased) T3 and T4 levels (reduced) in all treated groups. Thyroid weight was increased and associated histopathological chnages were observed only at the highest dose level. The author therefore proposes a NOAEL of 1 mg/kg bw/d for this study. The effects of ammonium perchlorate on the thyroid are consistent with the known therapeutic mode of action of perchlorates (including potassium perchlorate) which have been used for decades to treat hyperthyroid disorders.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only available data

Repeated dose toxicity: via oral route - systemic effects (target organ) glandular: thyroids

Justification for classification or non-classification

No classification is proposed. Although the 90 -day toxicity study indicated the thyroids as a clear target organ at relatively low dose levels, the effects seen in this study are not considered to be of sufficient severity to warrant classification for repeated dose toxicity (STOT-RE) under the CLP Regulation.