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Administrative data

Description of key information

A tentative assessment of the repeated dose toxicity of AgI is presented. The hazard assessment for this and other inorganic silver substances is based on the silver ion or elemental silver. The other ions or moieties contained in the different substances (e.g. Cl, Br, I, nitrate...) are not considered to contribute to the systemic toxicity. Thus, grouping these substances is justified. 
Because limited relevant/reliable toxicological data is available, some results of the assessment of repeated dose toxicity of silver compounds have to be seen as tentative and will be revised in the future. The registrant (organised in the precious metals consortium) is aware of relevant on-going long-term toxicological studies, such as on nano-silver and silver acetate. It is expected that this data becomes available during 2013, after which the hazard assessment will be revised.
Silver iodide is considered a poorly soluble substance of low to negligible bioavailability. Thus, it is grouped together with Ag, Ag2O, AgCl and AgBr into the group of insoluble/poorly soluble silver substances (see also introduction to chapter 5 in the CSR).
Further details are presented in the report “Derivation of DNELs for poorly soluble and soluble silver compounds”, which is attached to the endpoint summary on toxicological information in the technical dossier and to the CSR.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Study duration:
subchronic
Species:
rat

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

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Key study. NOAEL expressed as mg Ag/kgbw/day!

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Waiving. The SCOEL occupational exposure limit is adopted as the DNEL for systemic effects via inhalation for workers.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Waiving.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Waiving.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Waiving.

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification

The current knowledge about toxicological effects of silver substances in general and silver iodide in particular leads to the conclusion that hazard classification is not required for any CLP classification criterion related to repeated exposure.

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