Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt

Endpoint summary

Description of key information

No acute oral toxicity study is available for the target substance C16 -18 Sulfosuccinate.

The acute oral toxicity of the source substance C12-18 Sulfosuccinate is low. A key study is available with test item containing ≥ 90 % a.i. dosed by gavage in Wistar rats at 480, 1400 and 2000 mg/kg bw (BASF SE, 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 LD50 was between 580 and 1400 mg/kg for male and female rats, and therefore the test item was considered harmful. Two supporting studies for acute oral toxicity by gavage were available. In the first supporting study, the test item containing ≥ 90 % a.i. was tested by oral gavage in male and female Wistar rats (BASF SE, 1986). The male LD₅₀was > 2000mg/kg bw, the female male LD₅₀was ca. 1400 mg/kg bw. In the second supporting study, the test item containing ≥ 90 % a.i. was tested by oral gavage in male Wistar rats (BASF SE, 1969). The test item was administered by single gavage in aqua dest. as solvent and an application volume of 20 mL/kg bw to fasted animals at doses of 1580, 1990, 2510 and 3160 mg/kg bw. Ten male rats were used per sex and dose. The LD50 was 2400 mg/kg bw.

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

Acute dermal toxicity:

No acute dermal toxicity study is availabe for the target substance C16 -18 Sulfosuccinate.

The acute dermal toxicity of the source substance C12-18 Sulfosuccinate is low. A key study for acute dermal toxicity according to OECD 402 was conducted with the substance containing > 95 % a.i. (BASF, 2013). A 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 conclusion, as LD₅₀exceeds 2000 mg/kg bw and only very slight erythema was observed, there is no acute dermal toxicity hazard.

The same is assumed for C16 -18 Sulfosuccinate.

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:

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 acute oral toxicity study is available for the target substance C16 -18 Sulfosuccinate. The acute oral toxicity of a close homolog C12 -18 Sulfosuccinate (containing >= 90% act. ingr.) was tested by gavage in Wistar rats at dose levels of 580, 1400 and 2000 mg/kg bw. The test compound was administered by single gavage in aqua dest. as solvent and application volume of 20ml/kg bw to fasted animals. Two (low and mid dose) or five (high dose) were used per sex and dose. Clinical observations and gross macroscopic observations were observed at all dose levels. The LD50 was < 1400 mg/kg bw and > 580 mg/kg bw for female and male rats.

Based on the information of the close homolog, C16 -18 Sulfosuccinate was considered harmful if swallowed.

No acute dermal toxicity study is availabe for the target substance C16 -18 Sulfosuccinate. Acute dermal toxicity testing in rats of a close homolog, C12 -18 Sulfosuccinate was conducted. 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 (5cm x 6cm, 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 animals on test days 2 and 3. All nimals gained the expected body weight throughout the whole experimental period. No macroscopic findings were observed at necropsy. In conclusion, as the LD50 exceeds 2000 mg/kg bw and only very slight erythema was observed, there is no acute dermal toxicity hazard.

Based on the information of the homolog, C16 -18 Sulfosuccinate is also not expected to be acute toxic after dermal application.

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.

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. Based on the argumentation summarized above an acute inhalation toxicity study is waived.

 

Justification for classification or non-classification

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 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 dermal toxicity.