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Description of key information

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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 450 mg/kg bw
Quality of whole database:
Reliable

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliable

Additional information

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 ingredient/kg bw.

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.

Justification for classification or non-classification

Based 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 2008).

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