Safety evaluation of certain food additives - ipcs inchem

POLYDIMETHYLSILOXANE (addendum) 171
causing local irritation. There were no test article–related neoplastic or
preneoplastic changes in the animals in the oncogenicity group. A statistically
significant increase in the incidence of islet cell adenomas of the pancreas was
observed in the 100 mg/kg bw per day group males after 2 years of treatment.
However, the lack of relevant increased preneoplastic changes in the pancreas, lack
of effect in the female groups, high incidences of islet cell adenomas in the control
group animals assigned to the chronic recovery group and reported historical
incidence ranges in control group animals suggested that the increased incidence
of islet cell adenomas in the 1000 mg/kg bw per day group was not test article
related. There were no indications of systemic toxicity when 10 cSt PDMS fluid was
administered to rats for 24 months. There were no effects on survival that could
have had a negative impact on the objectives of the study. Evidence of local irritation
was noted in the eye and the nasolachrymal duct. There were no treatment-related
neoplastic findings at any dose level. Based on the results of this study, the noobserved-effect
level (NOEL) for systemic toxicity and oncogenicity of 10 cSt
PDMS fluid administered in the diet for 12 months and 24 months, respectively, to
F344 rats was 1000 mg/kg bw per day for males and females (United States
Environmental Protection Agency, 2003; Meeks et al., 2005).
2.3 Observations in humans
In an evaluation of human exposure, it was concluded that PDMS is not
absorbed to any appreciable extent through the skin or from the gastrointestinal
tract, from which it is rapidly excreted unchanged in the faeces (European Centre
for Ecotoxicology and Toxicology of Chemicals, 1994).
3. DIETARY EXPOSURE
PDMS is a silicon-based organic polymer that is used as an antifoaming
agent in fruit and vegetable juices, an anticaking agent in confectionery and flour
products, and an emulsifier in edible oils essentially free of water.
PDMS is included in the current version of the Codex General Standard for
Food Additives (GSFA) for use in a wide range of foods at acceptable maximum
levels from 10 to 110 mg/kg food (Table 2).
Table 2. Acceptable maximum use levels of PDMS in foods in version of the
GSFA prior to 2008 revisions (current version at Codex Alimentarius
Commission, 2008)
GSFA/Codex
food category
Food group name Maximum
use level
(mg/kg)
01.5.1 Milk powder and cream powder (plain) 10
02.1.2 Vegetable oils and fats 10
02.1.3 Lard, tallow, fish oil and other animal fats 10