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EC number: 229-722-6
CAS number: 6683-19-8
No mortality was observed after oral, dermal, inhalatory or
intraperitoneal application of a single dose of 5000 mg/kg body weight,
3160 mg/kg body weight, 1951 mg/m³ and 1000 mg/kg body weight,
respectively. All studies were performed prior to GLP requirements but
are adequately reported for evaluation. Minor deviations include the
recording of body weight or autopsy findings for some studies. Transient
clinical signs resolved within the post-treatment observation period.
There were no findings indicative of target organ toxicity. Acute oral,
intraperitoneal and inhalation toxicity was studied on rats. Acute
dermal toxicity was investigated on rabbits. Acute oral toxicity was
also studied in mice.
TABLE 2. PHARMACOTOXIC SIGNS
Mild = +; Moderate = ++; Severe = +++
TABLE 3. MEAN BODY WEIGHT ± SD (GRAMS)
The test substance has been investigated in six acute oral toxicity
studies, two acute inhalation studies, one acute dermal study and one
acute intraperitoneal study and all studies consistently show absence of
mortality and target organ toxicity. All studies were performed prior to
the introduction of GLP and OECD guidelines. However, they were reported
in sufficient detail to conclude that the procedures are sufficiently
similar to the OECD guidelines, especially in regard to dose levels,
treatment duration and endpoints.
Acute oral toxicity
For acute oral toxicity, three studies are available that were all
performed with doses of up to 5000 mg/kg bw. Two studies used male rats
whereas the third study used female mice. Sufficient details are
reported to allow evaluation of the studies. For all studies, a single
dose was given by gavage, and the procedures are comparable to OECD
testing guidelines for acute oral toxicity. For the studies by Drake, a
post-observation period of 30 days was applied, but necropsy was not
included. No mortality and no treatment-related clinical signs were
recorded in any of the three studies. Two additional studies are
available testing two different batch materials of the test item. In
these studies, dose levels of up to 10000 mg/kg in were administered by
gavage to both male and female rats. Mortalities occurred among the male
test animals (one male of the control group, one male of the low dose
and one male of the high dose) probably unrelated to treatment. All
female animals survived. Diarrhea, slight hypoactivity and rough coat
were recorded until day 3 after administration. Body weight gains were
within the expected range. The LD50 values derived in both studies were
greater than 10000 mg/kg. In conclusion, the acute oral toxicity of the
test article is very low with LD50 values above the regulatory testing
Acute dermal toxicity
The acute dermal toxicity study was performed with 4 female and 4 male
rabbits, each two having abraded skin. The test item was identified with
a code without further information. It was applied with an occlusive
wrapping in corn oil at doses of 100, 316, 1000 and 3160 mg/kg body
weight for 24h. There was no mortality, no clinical signs and no effect
on body weight gain. Dermal effects were observed at 100 and 3160 mg/kg
only: After 24 h exposure, slight erythema was observed in all animals
until 1-4 days after exposure. Slight desquamation was noted on the area
of exposure in two animals (one from each level) for 3-7 days, which had
subsided at the end of the observation period. No information is given
whether this was observed for rats with the abraded or intact skin. At
termination, there were no signs of dermal irritation in any animal.
There were findings upon necropsy. With the limitation in reporting
details, the study is adequate for hazard assessment.
Acute inhalation toxicity
The key study for acute inhalation toxicity was performed with a
commercial product with a nose-only set-up. Its design and reporting
details are adequate for hazard assessment. Rats were exposed to
aerosols with concentrations of 0, 762 and 1951 mg/m³ for 4h. At least
82% of the particles had a diameter of less than 7 µm. Concentrations
were determined gravimetrically. Exophthalmus and ruffled fur were
observed until 2-5 days after exposure. No mortality occurred. There
were no effects on body weight gain and no findings upon necropsy.
Acute toxicity by other routes
Upon intraperitoneal injection of 1000 mg/kg body weight, both male and
female rats showed dyspnoea, exophthalmus, ruffled fur and curved body
posture from which they recovered within 9 days. Body weight gain was
not affected during the 14-day observation period. Necropsy findings
included peritoneal adhesions or pseudomembranes around the spleen in
all animals; one female had also adhesions around the kidney. The study
is adequately reported for evaluation.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. As a result the
substance is not considered to be classified for acute toxicity under
Regulation (EC) No. 1272/2008.
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