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EC number: 272-657-3
CAS number: 68901-15-5
Oral (equivalent to OECD 401), rat: LD50 = 620.42 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test)
Table 1. Results of the acute toxicity
Dose level (mg/kg bw)
The acute oral toxicity of the test
substance was assessed in an acute toxicity test equivalent to OECD
Guideline 401 (1984). A range-finding study was performed to determine
the appropriate dose level of the test substance for the main study. Two
female Wistar rats per dose group received once 1.0 or 2.5 mL/kg bw
undiluted test substance (equivalent to approx. 1020
and 2550 mg/kg bw) or 500 or 750 mg/kg bw test substance at
concentration of in arachis oil. All animals at dose level of approx.1020
and 2550 mg/kg bw died within 24 h after administration. No
mortality occurred at 500 and 750 mg/kg bw.
Based on the results of the
range-finding study, five male and five female Wistar rats per dose
group received 250, 500, 750 or 1000 mg/kg bw test substance at
concentration of 25% in arachis oil once by oral gavage. Animals were
observed 20 min and 1, 2, 3, 6, 24 and 48 hours after administration and
subsequently once daily for 14 days. Furthermore, individual body
weights were determined on Days 0 and 14 and macroscopic examination was
performed on test Day 14 at terminal sacrifice. No mortality occurred at
250 mg/kg bw during the study period. At 500 mg/kg bw three animals died
within 3 days, at 750 mg/kg bw five animals died within 6 days and all
animals died at 1000 mg/kg bw within 3 days after administration.
Clinical signs such as apathy, posture anomalies, ataxia, decreased
excitability, piloerection, ptosis and dark red coloured urine were
observed as a result of the treatment. The symptoms occurred in
surviving animals reaching a peak intensity between 20 min and 48 h
after administration. Animals which died before study termination showed
the aforementioned clinical signs with constant intensity until exitus.
Based on the results of this study, the LD50 value was calculated to be
620.42 mg/kg bw in rats.
The acute dermal toxicity of the test
substance was assessed in a limit test performed in 5 male and 5 female
Sprague-Dawley rats according to OECD Guideline 402 and in compliance
with GLP (1999). A single dose of 2000 mg/kg bw of the test substance
was applied to the clipped skin of rats under semi-occlusive conditions
for 24 hours. Animals were subjected to daily observations and weekly
determination of body weight. Macroscopic examination was performed
after terminal sacrifice on Day 15. There was no mortality, no effects
on body weight gain and no signs of skin irritation during the 14-day
observation period. No abnormalities were found at macroscopic post
mortem examination of the animals. The LD50 value for dermal toxicity is
considered to be > 2000 mg/kg bw.
The available data on acute oral toxicity of
the test substance meet the criteria for Acute Tox. Cat 4 (H302)
according to Regulation (EC) 1272/2008.
The available data on acute dermal toxicity
of the test substance do not meet the criteria for classification
according to Regulation (EC) 1272/2008, and are therefore conclusive but
not sufficient for classification.
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