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EC number: 203-492-7
CAS number: 107-46-0
In the key oral acute toxicity
study (Bushy Run Research Center, 1982) in rats the LD50 was determined
to be > 16.0 ml/kg (12.16 g/kg bw) for males and females.
The key inhalation study
(Dow Corning Corporation, 1997) in rats gave an LC50 of 15956 ppm (ca.
In the key acute dermal toxicity
study (Institut Francais de Recherches et Essais Biologiques, 1982), the
LD50 for male and female rats was determiend to be >2000 mg/kg.
Table 1: Concentrations,
exposure conditions and number of evident toxicity per animals
Analytical Conc. (ppm)
Number dead/Number exposed
Other results from supporting studies in rats are in agreement with the
conclusion that D4 is not harmful via the oral route.]
In the key acute oral study (Bushy Run Research Center, 1982)
Hilltop-Wistar rats (5 animals/sex/dose) were administered 8 or 16 ml/kg
bw of HMDS by oral gavage then observed for 14 days. Animal
weights were recorded at 0 days (before dosing), 7 days and 14
days (just prior to sacrifice). At death or sacrifice, each
animal was subjected to gross pathologic evaluation. The only death was
a male in the low dose group, which showed sluggishness and
unsteady gait at 4 minutes and death at 15 minutes. Necropsy revealed
lungs with dark spots, dark liver, liquid-filled, injected stomach, and
red intestines and kidneys. There were no adverse findings in the
animals that survived. The LD50 was >16 ml/kg bw (equivalent
to 12160 mg/kg bw). A number of supporting studies (Reliability 2 or 4)
confirm that the acute oral LD50 for HMDS in rats is well in
excess of the dosing limit of current guidelines and it is therefore not
harmful for acute exposures via the oral route.
In the key acute inhalation study (Dow Corning Corporation, 1997)
Sprague-Dawley rats (5 animals/sex/dose) were exposed to HMDS at
concentrations of 10067; 14050 and 16659 ppm for 4 hours then observed
for 14 days.
At death or sacrifice, each
animal was subjected to gross pathologic evaluation
Animals exposed to concentrations of
14050 and 16659 ppm experienced prostration
and convulsions. Ataxia was also observed in the high
exposure group. The primary clinical sign after the exposure
was porphyrin staining of the eyes and face; this was
evident in some of the animals of the two higher exposure
groups for the entire observation period.
In animals that died, congestion
and/or hemorrhage of various lobes of the lung were observed
in males and females. Congestion of the lungs was also noted
in one female from each of the two higher exposure groups at
the final sacrifice of the animals that survived exposure. The LC50
was 15,956 ppm with (95% confidence limits of 14,024-34,045). There are
no reliable supporting studies for the acute inhalation route for HMDS.
In the key acute dermal study (Institut Francais de Recherches et Essais
Biologiques, 1982) Sprague-Dawley rats (5 animals/sex) had HDMS applied
to their skin under occlusive conditions at a dose of 2000 mg/kg bw, the
skin was not rinsed and the animals were then observed for 14 days.
There were no mortalities, clinical signs of toxicity, adverse necropsy
findings or indications of local skin irritation. There are an
additional two studies that support the conclusion that HMDS is not
harmful for acute exposures via the dermal route.
Based on the available oral, dermal and inhalation toxicity data, HMDS
does not meet the criteria for classification for acute toxicity
according to Regulation (EC) 1272/2008.
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