Reaction mass of 1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane and 1,6-diiodoperfluorohexane

Endpoint summary

Description of key information

Key study: Acute inhalation read-across from supporting substance according to OECD 403: 4h LC50 4.5 mg/l

Supportive study: inhalation Testicular and liver changes at 3.7 mg/l

Supportive study: oral : No mortality up to 3400 mg/l, but findings were: enlarged liver with mild centrilobular hypertrophy; moderate degeneration/atrophy of seminiferous tubules in testes;

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

4.5 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A 4h inhalation (nose only) assay, tested on the analogue substance cas 422-91-3, was considered to be more relevant information to classify instead of the assay done on the registered substance due to the more stringent values obtained on the first, which could be explained by the fact that the exposure with the analogue was (nose only), while the assay on the registered substance the exposure was (whole body). Based on a 4-hour LC50 in rats of 4.5 mg/L air, tested on an analogue substance CAS 422-91-3, the substance is classified as acute toxic cat. 3 (H331: Toxic if inhaled) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the oral LD0 in rats of > 3400 mg/kg, no classification is required for acute oral endpoint according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

According to the supportive study: inhalation Testicular and liver changes at 3.7 mg/l, the effect observed in the testes is likely related to the action of deiodinase enzymes which are primarily located in the liver.  Because of this, the effect may be observed after either oral or inhalation dosing assuming that the compound is sufficiently bioavailable. Since there was evidence of systemic toxicity following either oral or inhalation dosing, it is reasonable to assume that there is some bioavailability by both routes. Given these facts, the substance is classified for Specific target organ single exposure cat. 1. (H370: Causes damage to organs (male reproductive organs) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard) according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.)