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EC number: 235-935-5
CAS number: 13052-09-0
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 key studies available for the inhalation or the dermal
The acute oral toxicity was investigated in
a group of five male and five female CD rats at a dosage of 2000 mg/kg.
The animals were starved overnight prior to dosing and the test material
was administered at a constant volume-dosage of 10 ml/kg in maize oil.
Mortality and signs of reaction to treatment were recorded during a
subsequent 14-day observation period. The animals were killed on the
following day and subjected to necropsy. There was no death and no sign
of reaction to treatment. The animals achieved expected bodyweight gains
revealed no significant macroscopic lesion.
Under the conditions of this study, the acute oral median lethal dosage
(LD50) of the test material was greater than 2000 mg/kg.
Eight New Zealand White rabbits, equally
divided as to sex, weighing 2325 to 2960 grams were exposed. The hair
was clipped from the back of each rabbit. The skin was abraded for 1/2
of the rabbits in each group. The test material was applied, as
received, to the backs in doses of 1000, 2000, 4000, 8000 mg/kg bw. The
site of application was covered with gauze bandaging and occluded with
The rabbits were observed for death at 24
hours and daily thereafter for a total of 14 days. None of the animals
died, no other effects reported. The acute dermal toxicity in male and
female albino rabbits would be greater than 8000 mg/kg bw.
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 occurred.
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, supported by the 1976 test results. Additional testing for
such organic peroxides is therefore not required and would not be in
line with animal welfare legislation.
Based on the results of the acute oral
toxicity study, the data is conclusive but not sufficient for
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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