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Administrative data

Description of key information

Key studies for oral and dermal acute toxicity were performed with read-across substance CAS 68784 -08 -7, demonstrating LD50 >2000 mg/kg bw after both routes. 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:
2 000 mg/kg bw
Quality of whole database:
High quality

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:
High quality

Additional information

Acute oral toxicity

In a key oral acute toxicity study, read-across substance CAS 68784 -08 -7 was examined for acute toxicity after a single oral administration to 6 female rats with a test item containing 41.5% active ingredient (Haferkorn, 2013a). The test item dosed by oral gavage at 2000 mg active ingredient/kg bw did not reveal any signs of toxicity. 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 LD50 value was ranked exceeding 2000 mg/kg bw. In conclusion there was no hazard for acute oral toxicity.

 

Acute dermal toxicity

In a key dermal toxicity study, read-across substance CAS 68784 -08 -7 was examined for acute toxicity after a single dermal application to rats of test item containing 41.5% active ingredient (Haferkorn, 2013b). One dose level of 2000 mg active ingredient/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 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, LD50 exceeded 2000 mg/kg bw and there was no hazard for acute dermal toxicity;

 

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

- The substance did not demonstrate any hazard for acute oral and dermal toxicity.

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

 

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 CLP Guidance (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.