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EC number: 943-024-5
CAS number: -
There are 6 acute oral, 4 acute dermal and one acute inhalation studies, a number of which are guideline GLP studies, for different hydrotrope substances. By EU criteria these hydrotrope substance are deemed "practically non-toxic" for oral, dermal and inhalation exposure.
There are a total of 11 acute toxicity studies on the hydrotrope
category substances, six by the oral route, four by the dermal route and
one by inhalation.
The key acute oral study is a 1982 study with sodium cumene sulphonate
which follows OECD 401 guideline but not GLP. It is a limit test of 5
males and 5 females exposed at 7000 mg/kg bw . Two female rats died.
There were some clinical signs of stress following dosing but all
animals were free of clinical symptoms at 24 hours. There were no
effects on body weights and no pathological changes at the 14 day
necropsy. The LD50 was recorded as greater than 7000 mg/kg bw and per EU
criteria the test substance was deemed "practically non-toxic". The
other 5 oral studies show comparable results.
The key acute dermal toxicity is a 1968 study with sodium cumene
sulphonate which is generally equivalent to OECD 402. It was a limit
test. Six rabbits (3 with shaved and abraded skin and 3 with intact
shaved skin) were exposed to 2000 mg/kg bw. There were no deaths but
primary irritation was reported at the site of exposure. Body weights
were normal at 14 days and there were no gross pathology or
histopathology noted at sacrifice. The dermal LD50 is reported as >2000
mg/kg bw. The other three acute dermal studies reported comparable
The key acute inhalation study is a 1980 (non-GLP) study with ammonium
xylene sulphonate. This is a 232-minute, limit test, involving exposure
of male and female rats with no vehicle and a 14-day post exposure
observation period. There were no deaths at the 6.41 mg/L dose.
Aerosolization was done by a DeVilbiss Nebulizer and exposures were in
glass chambers. One of the 10 animals demonstrated clinical signs (soft
stool), 2 of the 10 had slight weight gains at days 7 and 14, and 5 of
the 10 showed slight mottling or a moderate congestion of lungs at
necropsy. The conclusion was reported as "practically nontoxic".
The available studies with oral, dermal and inhalation exposure
demonstrate that the members of the hydrotrope category are of low acute
toxicity. No classification is warranted.
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