Registration Dossier

Administrative data

Description of key information

Except for an acute oral toxicity study, no test data were available for current substance, however read across data were available from read-across substances CAS No. 23386-52-9 and CAS No. 848588-96-5.   LD50 values were > 2000 mg act.ingr./kg bw. for oral and dermal acute toxicity in key and supporting studies. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties.

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:
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:
3 500 mg/kg bw

Additional information

Except for an acute oral toxicity study, no test data were available for current substance, however read across data were available from CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate) and CAS number 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt). Justification for read across within the category of sulfosuccinates Diesters is documented in a separate document attached in Section 13.

 

Acute oral toxicity

- A key acute oral toxicity study with a formulation of the registered substance containing 63 - 67% active ingredient was tested in 10 Wistar rats (5 males and 5 females) by oral gavage at a dose of 2000 mg/kg bw test material (Hofman and Jung, 1988). No mortality was observed. On the day of application the animals showed nonspecific signs of toxicity. The female animals showed in addition adverse effects of the movement sequence, respiration and diarrhea. From the second day post application all the symptoms were reversible. There were no adverse effects on the bodyweight gain. No gross pathology of the euthanized animals was observed.The LD50 in male and female Wistar rats is >2000 mg/kg bw (test material) or >1260 mg/kg bw (active ingredient).

- Supporting oral acute toxicity studies were available from:

a. source chemical CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate), which was tested in 5 male albino Wistar rats with a test item containing 80% active ingredient (American Cyanamid Company, 1969a). Final doses were 10.0, 5.0, 2.5 and 1.25 g act. ingr./kg bw. In the 10.0 and 5.0 g/kg bw dose group all 5 animals died within 6 hours after dosing. In the 2.5 and 1.25 g/kg bw dose group all animals survived the 14 days observation period. In all dose groups signs of intoxication were observed. The LD50 was calculated to be 3540 mg/kg on product basis or 2830 mg active ingredient/kg bw.

b. source chemical CAS No. 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt), tested in male and female Wistar rats with a test item containing 70% active ingredient at 10, 5, 2.5 and 1.25 mL/kg bw, corresponding to 7000, 3500, 1750 and 875 mg act.ingr./kg bw (American Cyanamid Company, 1968a).There were no mortalities. There were no signs of intoxication observed and gross autopsy was normal. The oral LD50 was >10 mL/kg bw or >7000 mg act.ingr./kg bw.

In conclusion, based on the registered substance and read across data from key and supporting studies, there is no acute toxicity hazard as LD50 is >2000 mg/kg bw (active ingredient).

 

Acute dermal toxicity

For acute dermal toxicity, following read across data were available:

- source chemical CAS No. 23386-52-9 (Sodium dicyclohexyl sulfosuccinate - 80% purity), which was tested at 5.0 g/kg bw in 10 male albino rabbits on clipped skin under covered application. There was one mortality at day 6 and weakness of the hind legs was seen in one animal. The survivors showed no gross autopsy. There was a severe erythema and severe edema followed by eschar formation. Dermal LD50 was >5000 mg/kg bw. Taking into account that the product contained 80% active ingredient, the LD50 corresponds with >4000 mg active ingredient/kg bw (Key study; American Cyanamid Company, 1969b).

- source chemical CAS No. 55184-72-0 (Butanedioic acid, sulfo-, 1,4-diisotridecyl ester, sodium salt - 70% purity), which was tested in 2 groups of 5 male albino rabbits on shaved skin under covered application for 24 hours at dosages of 5.0 mL/kg and 2.5 mL/kg, corresponding to 3500 and 1750 mg active ingredient/kg bw. There were no mortalities. There were 2 animals with diarrhea but gross autopsy was normal. The oral LD50 of the test item was > 5 mL/kg bw or > 3500 mg active ingredient/kg bw (Supporting study; American Cyanamid Company, 1968b).

Based on the above data, current test item can also be considered to be practically non-toxic by single skin applications.

In conclusion, based on the read across data, there is no acute toxicity hazard as LD50 is >2000 mg/kg bw.

 

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 is waived.

Conclusion

Except for an acute oral toxicity study, no test data were available for current substance, however read across data were available from read-across substances CAS No. 23386-52-9 and CAS No. 848588-96-5. LD50 values were > 2000 mg act.ingr./kg bw. for oral and dermal acute toxicity in key and supporting studies. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties.


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.