Registration Dossier

Administrative data

Description of key information

The oral LD50 is > 2000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. There are no studies available for the inhalation or the dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
A K1 study is available.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The registered substance was not acutely toxic to rats when tested by the oral gavage route. Based on the pattern of use ingestion by humans is unlikely.

An acute toxicity study via the dermal route was not performed since this is scientifically unjustified, for details see above. A weight of evidence approach is scientifically applicable for chemically comparable organic peroxides and allows one to conclude also a dermal LD50 > 2000 mg/kg bw for the untested organic peroxide.

An acute toxicity study via the inhalation route was not performed and can be waived according to REACH Annex VIII since exposure via this route is unlikely.

Justification for selection of acute toxicity – oral endpoint

K1:The study is performed according to OECD guidelines and GLP. LD50 >2000 mg/kg bw, no mortalities occured.

Justification for selection of acute toxicity – inhalation endpoint

In accordance with column 2 of REACH Annex VIII, the test for acute inhalation toxicity (required in section 8.5) does not need to be conducted. Testing by the inhalation route is not appropriate since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to droplets of an inhalable size. The vapour pressure is very low (see section 4.6) and the pattern of use does not lead to the formation of droplets of an inhalable size.

Justification for selection of acute toxicity – dermal endpoint

Numerous organic peroxides have been tested in acute dermal toxicity tests (41 organic peroxides covering all chemical subgroups/families of organic peroxides, excluding hydroperoxides). Experimental data of all of these organic peroxides, (except hydroperoxides), show no toxic effects at dermal application up to the tested concentration limit of 2000 mg/kg bw and show for this reason an acute dermal toxicity of >2000 mg/kg bw. Therefore, a weight of evidence approach is scientifically applicable for chemically comparable organic peroxides and allows one to conclude also a dermal LD50 > 2000 mg/kg bw for the untested organic peroxide.  Additional testing for such organic peroxides is therefore not required and would not be in line with animal welfare legislation.

Justification for classification or non-classification

Based on the results of the acute oral toxicity study, the data is conclusive but not sufficient for classification.