SDS

SCS2811T
Page:10/13
Version:
1.4
Date of issue/Date of revision:
02/02/2016
Date of previous issue:
02/02/2016
Remarks:
NOAEC
NOAEL
Dermal
Rabbit
> 1 mg/kg
OECD 410
3 weeks
Remarks:
NOAEL
Conclusion/Summary
:
Not determined
General
:
Once sensitized, a severe allergic reaction may occur when
subsequently exposed to very low levels.
Carcinogenicity
:
No known significant effects or critical hazards.
Mutagenicity
:
No known significant effects or critical hazards.
Teratogenicity
:
May damage the unborn child.
Developmental effects
:
No known significant effects or critical hazards.
Fertility effects
:
May damage fertility.
Numerical measures of toxicity
Acute toxicity estimates
Route
ATE value
Oral
32,482.3 mg/kg
Other information
Octamethylcyclotetrasiloxane (D4) Ingestion: Rodents given large doses via oral gavage of
Octamethylcyclotetrasiloxane (1600mg/kg/day,14 days), developed increased liver weights relative to
unexposed control animals due to hepatocellular hyperplasia (increased number of liver cells which appear
normal) as well as hypertrophy (increased cell size). Inhalation: In inhalation studies, laboratory rodents
exposed to Octamethylcyclotetrasiloxane (300 ppm five days/week, 90 days) developed increased liver weights
in female animals relative to unexposed control animals. When the exposure was stopped, liver weights
returned to normal. Microscopic examination of the liver cells did not show any evidence of pathology. This
response in rats, which does not affect the animal's health, is well-documented and widely recognized. It is
related to an increase of liver enzymes that metabolize and eliminate a material from the body. The increased
liver weight reverses even while the D4 exposure continues. The finding is not adverse, but is considered a
natural adaptive change in rats, and does not represent a hazard to humans. Inhalation studies utilizing
laboratory rabbits and guinea pigs showed no effects on liver weights. Inhalation exposures typical of industrial
usage (5-10 ppm) showed no toxic effects in rodents. Range finding reproductive studies were conducted
(whole body inhalation, 70 days prior to mating, through mating, gestation and lactation), with D4. Rats were
exposed to 70 and 700 ppm. In the 700 ppm group, there was a statistically significant reduction in mean litter
size and in implantation sites. No D4 related clinical signs were observed in the pups and no exposure related
pathological findings were found. A two-year, combined chronic/carcinogenicity study, during which rats were
exposed to D4 by inhalation, data showed a statistically significant increase in a benign uterine tumor in female
rats exposed at the highest level--a level much higher than the low levels that consumers or workers may
encounter. An expert panel of independent scientists who have reviewed the results of this research concur that
the finding seen in the two-year study occurred through a biological pathway that is specific to the rat and is not
relevant to humans. Therefore, this observed effect does not indicate a potential health hazard to humans. In
developmental toxicity studies, rats and rabbits were exposed to D4 at concentrations up to 700 ppm and 500
ppm, respectively. No teratogenic effects (birth defects) were observed in either study.
Section 12. Ecological information
Ecotoxicity
Conclusion/Summary
:
Not available
Persistence/degradability