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EC number: 219-702-5
CAS number: 2500-88-1
Acute toxicity after single oral application was tested in female rats, which received 15,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 15,000 mg/kg bw) dioctadecyl disulphide does not have to be classified as acute orally toxic.
Hostanox SE 10 was tested for its acute toxic properties in female rat
via oral route. No animal died or showed clinical symptoms/macroscopic
anomalies after application of 15000 mg/kg bw.
Therefore, the median lethal dose of Hostanox SE 10 (LD50) was greater
than 15000 mg per kg body weight. Based on the result of this study the
test item is not subject for labelling and classification requirements
according to regulatory requirements.
on the results of an oral toxicity study the LD50 value for acute oral
toxicity was considered to be greater than 15,000 mg/kg bw.
accordance with REACH “Column 2” in Annex VIII there is sufficient
weight of evidence from several independent sources of information
leading to the conclusion that Dioctadecyl disulphide does not exert
systemic toxic effects after acute inhalation exposure and thus does not
have to be classified, because
- the LD50 value for acute oral toxicity of Dioctadecyl disulphide is
greater 15,000 mg/kg bw,
- Dioctadecyl disulphide does not have to be classified as skin
- inhalation to consumer is very unlikely to occur, since the substance
is embedded in polymeric matrices for consumer applications and
- occupational health surveillance data obtained from workers of the
production site do not give any hint concerning adverse systemic effects
and effects on the respiratory tract (for expert statement please refer
to Chapter 7.10.1).
Therefore, it is concluded that testing of acute inhalation toxicity of
Dioctadecyl disulphide salt is not scientifically necessary.
can reasonably be deduced that Dioctadecyl disulphide does not exert
systemic toxic effects after dermal application and thus does not have
to be classified, because this substance did not cause lethal effects
after administration of a single oral dose of up to 15,000 mg/kg bw in
rats. Furthermore the substance does not have to be classified as skin
irritating. Due to the combination of its polar character (Sulfur bridge
in the center of the molecule) and the long extent of the alkyl chain it
is unlikely that higher amounts (limit dose of dermal toxicity testing
according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral
toxicity study (tested up to 15,000 mg/kg bw/d) will be systemically
available via the intact skin barrier even if the most unlikely amount
of 100% penetration is assumed. Therefore, testing is not scientifically
to the findings described in the acute oral toxicity study (LD50 oral in
rats greater than 15,000 mg/kg bw) Dioctadecyl disulphide does not have
to be classified as acute orally toxic. Based on the substance's
physico-chemical and non-irritant properties, as well as the
unlikeliness of exposure and the experience from occupational health
surveillance no higher systemic exposure via inhalation or dermal
penetration is expected to occur than that tested in the course of the
oral toxicity study. Therefore, Dioctadecyl disulphide does not have to
be classified as acute toxic.
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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