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EC number: 247-873-6
CAS number: 26650-05-5
A key oral acute toxicity study was
performed in rats by single oral dose of SBU 185 (50% active
ingredient), demonstrating an LD50 > 2450 mg act. ingr./kg bw.
Supporting acute toxicity studies were available in mice either by
single oral and single subcutaneous dose of SBU-185 (at least 49%
active ingredient), demonstrating LD50 of ca. 3450 and 1617 mg act.
ingr./kg bw, respectively. Inhalation acute toxicity is waived based on
the low vapour pressure of the registered substance which is1.75 x
10E-18 hPa at 25°C (EPIWIN). A key study for acute dermal
toxicity in rats with read-across substance Butanedioic acid, 2(or
3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and
C18unsaturated)alkyl))amino]ethyl]esters, disodium salts showed and LD50
>2000 mg active ingredient/kg bw and revealed no signs of toxicity and
no deaths at tested dose of 2000 mg/kg.
In a key oral acute toxicity study (Evonik,
1965) groups of male and female young adult albino
rats were given a single oral dose of SBU 185 (50% act.ingr.) at doses
of 1990, 2510, 6310, 8000 and 10000 mg/kg bw and observed for 14 days.
In the dose groups 1990, 2510, 6310, 8000 and 10000 mg/kg bw 10, 0, 0
,10 and 20% of animals died, respectively. Animals were found death on
the first or second day after application. No clinical signs or effects
on body weight were observed. Oral LD50 was >10000 mg test
material/kg bw, corresponding with >2450 mg active ingredient/kg bw
(worst case calculation as a 50% formulation of test material).
In a supporting acute oral toxicity study
(Evonik, 1961) groups of mice were given a single oral dose of SBU 185
(at least 49% act.ingr.) at doses of 20, 200, 2000, 4000, 6000 and 8000
mg/kg bw and observed for 24 hours. Up to and including a dose of 6000
mg/kg bw all animals survived. In the dose group of 8000 mg/kg bw 6/10
animals died. The oral LD50 for the test substance was
ca.7000mg, corresponding with an LD50 of ca. 3450 mg active
Intoxication due to acute inhalation
exposure of industrial workers or even the acute inhalation exposure as
such is very unlikely for sulphosuccinates due to their substance
properties and the risk management measures that are already
implemented. The vapour pressure of the registered substance is1.75 x
10E-18 hPa at 25°C (EPIWIN).Additional acute inhalation toxicity tests
would therefore neither lead to a better risk assessment, nor improve
the safety of applications. On the basis of the argumentation summarized
above an acute inhalation toxicity is waived.
In a key acute dermal toxicity study
(LPT, 2013), read-across substance Butanedioic acid, 2(or 3)-sulfo-,
4-[2-[(1- oxo(C12-C18(even numbered) and
C18unsaturated)alkyl))amino]ethyl]esters, disodium salts was tested in
rats. One dose level of 2000 mg/kg bw was administered on the shaved
intact dorsal skin, between the fore and hind extremities of 5 male and
5 female CD/Crl:CD(SD) rats. The read-across test item was held in
contact with the skin with 8 layers of gauze. The gauze was covered with
a plastic sheet and secured with adhesive plaster strips on the
application site for 24 hours. All animals were observed for a period of
14 days. Under the present test conditions, a single dermal
administration of 2000 mg active ingredient/kg bw to rats revealed no
signs of toxicity and no deaths. All animals gained the expected body
weight throughout the whole experimental period.No macroscopic findings
were observed at necropsy.
In a further
supporting acute toxicity study
(Evonik, 1961) groups of mice were given a single subcutaneous dose
of SBU-185 (at least 49% act.ingr.) at doses of 20, 200, 1000, 2000,
4000 and 8000 g/kg bw and observed for
24 hours.Up to and including a dose of 1000 mg/kg bw all animals
survived. In the dose groups of 2000, 4000 and 8000 mg/kg bw 3/10, 6/10
and 5/5 animals died, respectively. The subcutaneous
LD50 was ca. 3300 mg test material/kg
bw, corresponding with a subcutaneous LD50 of ca.
1617 mg active ingredient/kg bw.
on these results of registered and read-across substances, no
classification and labelling is needed for acute oral and dermal
toxicity according to the CLP regulation (No. 1272/2008 of 16 December
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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