Registration Dossier

Administrative data

Description of key information

A key study for oral acute toxicity was performed in mice, demonstrating LD50 of 11000 mg/kg bw. A key study for dermal acute toxicity was available from 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, showing LD50 >2000 mg/kg bw. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulphosuccinates due to their substance properties and the risk management measures that are already implemented.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
11 000 mg/kg bw
Quality of whole database:
Reliable (Klimisch 2)

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 (Klimisch 2)

Additional information

Acute oral toxicity
- In a key acute oral toxicity study, the registered substance was examined by gavage in male NMRI mice at doses of 1, 4.64, 10, 21.5, 31.6 and 46.4 mL/kg bw (Hackenberg, 1967). There were no very pronounced , specific toxic behavioral symptoms registered at the lower doses of 1 and 4.64 mL/kg bw. At doses ≥10 mL/kg diarrhea was seen. The died mice showed irritation of the mucous membranes of the stomach and small intestine. At the higher doses (21.5, 31.6 and 4.64 mL/kg bw/day), quiet apathetic behaviour, closed eyes and decreased sound activity were also observed. The LD50 at 7 days was 28.7 mL/kg. Recalculated LD50 referring to solid content of 39% (according to producer information) and an assumed density of roughly 1 was calculated to be ca. 11000 mg act. ingr./kg bw which is above limit dose.

- A supporting oral acute toxicity study 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' tested at 2000 mg active ingredient/kg bw did not reveal any signs of toxicity. (Haferkorn, 2013a) No death was recorded within the 14 days observation period. All animals gained the expected weight throughout the whole study period. No pathological changes were observed at necropsy. The LD50value was ranked exceeding 2000 mg/kg bw.

In conclusion there is no hazard for oral acute toxicity with registered substance.

 

Acute dermal toxicity
For the acute dermal toxicity testing, no test data were available for current substance, however read across data were available from 'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts'.

Justification for read across within the N2 (& N3) subgroup of sulfosuccinates is documented in a separate document attached in Section 13. A key dermal toxicity study with that test item containing 41.5% active ingredient was performed at one dose level of 2000 mg active ingredient/kg bw administered on the shaved intact dorsal skin of 5 male and 5 female CD/Crl:CD(SD) rats (Haferkorn, 2013b). The test item was held in contact with the skin under occlusive dressing for 24 hours. All animals were observed for a period of 14 days. The test item 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 conclusion it can be assumed that there is no hazard for dermal acute toxicity with registered substance.

 

Acute inhalation toxicity
Inhalation is very unlikely due to large particle size, low vapour pressure and high hydrophilic properties of the substance. Based on these and other physicochemical properties, the inhalation route is not appropriate; the oral and dermal route of administration are therefore applied as first and second relevant routes (ECHA R7a Guidance p 342). Additional inhalation testing 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 study is waived.

 

Conclusion

- No hazard was identified for acute oral and dermal toxicity based on read-across and registered substances.

- Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely.

- Further read-across information in provided in Section 13.


Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
Key study

Justification for classification or non-classification

Based on these results and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), the test substance does not have to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity.