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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key study: Subacute inhalation toxicity: 28 Day rat NOAEC < 0.198 ppm; Reliability: 2 Read across from CAS 375 -80 -4;

Supporting study: Sub-chronic toxicity: inhalation rat NOEC: < 0.1 ppm; reliability: 2;

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification

From the studies Subacute inhalation toxicity: 28 Day rat NOAEC < 0.198 ppm (read across from the analogue CAS RN 375-80-4) and the supporting sub-chronic toxicity: inhalation study rat NOEC < 0.1 ppm, the following evidences are weighed: although testicular effects occurs in repeated dose animal studies at a dose/concentration below the guidance value, < 1 mg/l/6h/day by the inhalation route, the nature of the effect may be indirect and caused by either deiodinase inhibition or  by an increase in free iodide. Looking at toxicity from free iodide salts there aren't any reported effects in testes. There does seem to be a link between increased iodide and decreased cholesterol, but doesn't seem to be a link between decreased cholesterol and testicular toxicity. We’re seeing the effect after a single dose. If this was enzyme inhibition (DI) it would be expected to be transient and show recovery, however there doesn’t seem to be much recovery in the data. Inhibition of the deiodinase would lead to hypothyroidism and that condition doesn’t seem to lead to testicular toxicity in rats. There isn't enough information to definitively claim the effects on testes are the result of deiodinase inhibition. liver changes noted in the repeat dose study were more adaptive than adverse (mainly hypertrophy).

Therefore the decision is to not classify STOT RE according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 because it’s already classified as REPRO 2 and STOT SE Cat 1 (with target organ "male reproductive organs").