DIOCTYL SODIUM SULFOSUCCINATE

Comments:

Considered for exposure only.

Intake:

The high (P95) dietary exposure estimates of DSS of up to 0.30 mg/kg bw per day for children aged 1–17 years could exceed this ADI. The estimates for adults were all below the ADI. Considering that (i) the dietary exposure estimates are conservative because of the assumptions that all soft drinks that could contain DSS do contain this food additive (although other food additives that perform the same function in foods are available) and, when DSS is used, it will always be present at the maximum and/or average use levels; and (ii) the ranges of exposure estimates based on only maximum use levels were comparable to those based on a combination of maximum and average use levels, JECFA concluded that the use of DSS as a food additive in soft drinks and fruit-flavoured water-based desserts does not pose a safety concern.

Meeting:

100

Report: 

Tox Monograph: 

Specification: 

ADI:

0-0.1 mg/kg bw

Comments:

JECFA concluded that dioctyl sodium sulfosuccinate could be evaluated on the basis of the limited data available because of the low intake anticipated from food additive uses, and consequently withdrew its request for a long-term study. However, because of the limited toxicological database on dioctyl sodium sulfosuccinate, JECFA increased the previous safety factor of 200 to 500. On the basis of a NOEL of 50 mg/kg bw from a reproductive study in rats and new safety factor of 500, JECFA established an ADI of 0-1.1 mg/kg bw for the food additive of dioctyl sodium sulfosuccinate.

Meeting:

44

Specs Code:

S

Report: 

Tox Monograph: 

Specification: 

Previous Years: