Butanedioic acid, sulfo-, 4-C12-14 (even numbered)-alkyl esters, disodium salts

Endpoint summary

Description of key information

Acute oral toxicity with read across substance CAS No. 90268-36-3 (Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >= 90% active ingredient  showed an LD50 between 580 and 1400 mg/kg for male and female rats in the key study; the registered substance was therefore considered harmful if swallowed. Acute dermal toxicity testing in rats with 2 read across substances did not reveal relevant changes and resulted in an LD50 > 2000 mg/kg bw.   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 and the risk management measures that are already implemented.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

580 mg/kg bw

Quality of whole database:

High quality (Klimish 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:

High quality (Klimisch 1)

Additional information

Acute oral toxicity

No data were available for the registered substance, but read across data were available from subgroup members (see separate read across justification document for the mono-ester sulfosuccinates in Section 13):

- A key study for acute oral toxicity was available with test item CAS No. 90268-36-3 ( Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >= 90% active ingredient dosed by gavage in Wistar rats at 480, 1400 and 2000 mg/kg bw (Potokar, 1987). Five (for low and mid dose) and two rats (for high dose) were used per sex. Clinical observations and gross macroscopic observations were observed at all dose levels. The LD₅₀was between 580 and 1400 mg/kg for male and female rats, and therefore the test item was considered harmfull.

- A supporting study with read across substance CAS No. 37294-49-8 ( Disodium C-isodecyl sulphonatosuccinate) in 5 male albino Wistar rats dosed with 50% active ingredient (Chemical Hygiene Fellowship Carnegie-Mellon Institute of Research, 1975a) at 10.0; 5.0 and 2.5 mL/kg bw (5000; 2500 and 1250 mg act.ingr./kg bw). All 5 animals died within 6-24 hours after dosing at the highest dose group. In the 5.0 mL (2500 mg act.ingr.)/kg bw dose group 3 of 5 animals died within 6-24 hours after dosing. The 2 survivors recovered after 3 days. In the 2.5 mL (1250 mg act.ingr.)/kg bw dose group all animals survived and recovered after 2 days. At 30 minutes they were sluggish at all dose levels. Gross autopsy showed slight changes in the lungs, livers, spleens, stomach, intestines and kidneys. The LD₅₀was 4.67 mL (2340 mg act.ingr.)/kg bw.

- In conclusion, the test item is considered of low toxic potential based on the most detrimental study, indicating an LD50 between 580 and 1400 mg/kg bw. For the LD₅₀value, 580 mg/kg was used as worst case value.

 

Acute dermal toxicity

No data were available for the registered substance, but read across data were available from category members (see separate read across justification document for the mono-ester sulfosuccinates in Section 13):

- A key study for acute oral toxicity was available with test item CAS No. 90268-36-3 ( Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts) containing >95% active ingredient (Haferkorn, 2013). One dose level of 2000 mg/kg bw was employed. The test item was applied once for 24 hours on the shaved intact dorsal skin of rats (5 cm x 6 cm, approx. 1/10 of body surface). This treatment was followed by an observation period of 2 weeks. There were no signs of toxicity and no deaths. A very slight erythema (barely perceptible) on the application site was observed in all 5 of 5 male and 5 of 5 female animals on test days 2 and 3. All animals gained the expected body weight throughout the whole experimental period. No macroscopic findings were observed at necropsy.

- In a supporting study with test item CAS No. 37294-49-8 ( Disodium C-isodecyl sulphonatosuccinate) containing 37% active ingredient (Carpenter, 1971a) at 10.0 and 5.0 mL/kg bw (3700 and 1850 mg act.ingr./kg bw), all 5 animals of the high dose group died within 6-24 hours after dosing, whereas the 5.0 mL/kg bw dose group all animals survived and recovered after 3 days. At 15 minutes animals were sluggish at both doses, at 1 hour there was diarrhea at 10 mL/kg. Gross autopsy showed changes in the lungs, livers, stomach, intestines, kidneys and adrenals. The LD₅₀was 7.07 mL (2620 mg act.ingr.)/kg bw.

- In conclusion, there is no hazard for acute dermal toxicity, based on read across substances showing LD₅₀values >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 study is waived.

Conclusion

- The substance is considered of low toxic potential based on the most detrimental study, indicating an LD50 between 580 and 1400 mg/kg bw. For the LD₅₀value, 580 mg/kg was used as worst case value.

- There is no hazard for acute dermal toxicity, based on read across substances showing LD₅₀values >2000 mg/kg bw.

- 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

Base upon read across data, the test substance is classified as HARMFUL and the symbol 'Xn' and risk phrase R 22 'HARMFUL IF SWALLOWED' are required according the EU labelling regulations Commision directive 93/21/EEC. According to CLP regulation (No. 1272/2008 of 16 December 2008), Category 4 classification is proposed for acute oral toxicity with signal word 'WARNING'.

Based on the read across data 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 dermal toxicity.

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