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EC number: 205-351-5
CAS number: 139-07-1
than a slight trend in reduced body weight and food consumption in males
at 1000 ppm, there were no treatment-related findings at 1000 ppm or
less. The highest dose of the test substance lead to 100 and 80%
mortality for 8000 and 4000 ppm group respectively indicating 1000 ppm
to be the maximal tolerated dose. The animals that survived at 4000 ppm
were cachectic and debilitated. The probable cause of death was ileus
and shock. The females showed less aberrations in all measurements than
at high doses was considered to occur at concentrations gastrointestinal
mucosa and resulting in dehydration and wasting or affects the
gastrointestinal flora. The observed effects were all related to the
irritation and corrosivity properties of the substance and no specific
organ toxicity was evidenced. The NOEL of the study was based on
reduction in body weight and body weight gain, consistent with decreased
food consumption. Therefore, it was concluded that all effects could be
attributed to local gastrointestinal irritaton/corrosion and consequent
reduced food intake without observing any primary systemic effect.
A study was conducted to determine the
repeated dose oral toxicity of the read across substance, C12-16 ADBAC
(active ingredient: approx. 80%), according to OECD Guideline 408 and US
EPA OPP 82 -1, in compliance with GLP. This sub-chronic oral toxicity
study (90 d) was realised in Sprague-Dawley rats. The rats were
administered daily dietary levels of 0, 100, 500, 1000, 4000 and 8000
ppm test substance, equivalent to 0, 6, 31 and 62 mg/kg bw/day (i.e. 0,
4.8, 25 and 50 mg a.i./kg bw/day) (males) and 0, 8, 38 and 77 mg/kg
bw/day (i.e. 0, 6.4, 30 and 62 mg a.i./kg bw/day) (females) for 95 and
96 days, respectively. Daily intakes at 4000 and 8000 ppm could not be
calculated due to high mortality. The animals were observed for
mortality, clinical signs, body weight, food consumption, hematology and
clinical chemistry at termination. Gross and histopathological
examinations were also performed. A slight trend in reduction of body
weight and food consumption in males at 1000 ppm was observed. Besides
this, there were no treatment-related findings at 1000 ppm or lower.
There was 80 and 100% mortality at 4000 and 8000 ppm, respectively.
Clinical signs of toxicity (general cachexia and loose faeces),
decreased food consumption and body weights, gross necropsy findings
(including increased amounts of liquids or semi-solid material within
the stomach, jejunum, ileum and cecum) were also observed at 4000 and
8000 ppm. The cause of morbidity and death was assumed to be shock
secondary to fluid and/or ionic shifts in the gastro-intestinal tract.
Under study conditions, the NOAEL for the C12 -16 ADBAC was considered
to be 500 ppm in the diet, i.e., equivalent to 31 mg/kg bw/day (i.e. 25
mg a.i./kg bw/day) for males and 38 mg/kg bw/d (i.e. 30 mg a.i./kg
bw/dayS) for females (Van Miller, 1988). Based on the results of the
read across substance study, the NOAEL for the test substance, C12
ADBAC, can be considered to be 500 ppm in the diet, i.e., equivalent to
31 mg/kg bw/day (i.e. 25 mg a.i./kg bw/day) for males and 38 mg/kg
bw/day (i.e. 30 mg a.i./kg bw/day) for females.
animal data on the skin irritation response
A study was conducted to determine the skin
irritation / corrosion potential of the read across substance, C12 -16
ADBAC (50 -80% active), according to US EPA OPPTS 870.2500. The
experiment was performed in rabbits. The undiluted test substance was
applied on intact and abraded skin sites using occlusive patches for an
exposure period of 24 h. The skin was then observed for erythema and
edema formation and the scoring was done according to the Draize,
Woodland and Calvery scoring system at 24 and 72 h from the onset of
exposure. Severe erythema and edema were observed in all the test
animals at both the abraded and intact sites. The mean Primary
Irritation Index (PII) of the test substance was calculated to be 6.29
and the mean values of erythema and edema were 3.33 (intact skin site),
3.5 (abraded skin site), 2.66 (intact skin site) and 3 (abraded skin
site). Under study conditions, C12 -16 ADBAC is considered to be
corrosive to rabbit skin (Wallace, 1975). Based on the results of the
read across study, the test substance, C12 ADBAC, can be considered to
be corrosive to rabbit skin.
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