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EC number: 234-147-9
CAS number: 10563-26-5
Acute oral: 950 mg/kg bw < LD 50< 1397 mg/kg bw (Similar to OECD TG 401; BASF SE, 1977)Acute dermal: LD 50 > 200 mg/kg bw (OECD 402; Air Products & Chemicals Inc, 2007)
The potential of the test substance (purity >97%) to induce acute
oral toxicity was evaluated in male and female SD rats in a test
protocol conducted similar to the OECD TG 401 with acceptable deviations
(BASF SE, 1977). Groups of 5 rats per dose were treated by gavage with
suspensions of the test substance in 0.5% Carboxylmethyl cellulose (CMC)
aqueous preparation at dose levels of 647, 950, 1397, 2043, and 3002
mg/kg bw. Group-wise documentation of clinical signs was performed over
the 14-day study period. Body weight was determined before the start of
the study only, as it was needed for determination of dose. The clinical
signs and findings were reported in summary form. All animals died in
the 2043 and 3002 mg/kg bw dose groups within 24 hours , 5/5 males and
4/5 females in the 1397 mg/kg bw dose group within 7 days, and 1/5 males
in the 950 mg/kg bw dose group within 7 days. No animal died in the low
dose group. Clinical signs included dyspnoea, poor general state,
apathy, abdominal or lateral position, spastic gait, atonia, and
diarrhea, generally noted in the 1397, 2043 and 3002 mg/kg bw dose
groups. Body weights generally decreased during the course of the study.
Erythema of the intestinal mucosa, acute congestive hyperemia,
dilatation of the heart, and acute cachexia were generally observed at
necropsy in the animals that died.
Therefore, based on the results of the study, an acute oral LD50 >
950 mg/kg bw and < 1397 mg/kg bw was assumed after administration to
The potential of the test substance to induce acute dermal
toxicity was evaluated in 2 studies (2 batches were tested) in a test
protocol conducted according to the OECD TG 402 (Air Products &
Chemicals, Inc., 2007) in healthy male and female New Zealand White
rabbits (2 males and 3 females in the first study [Project number MB
07-16376.02, TS purity = 83.4%] and in 3 males and 2 females in the
second study [Project number MB 07-16377.02, TS purity = 92.2%]). The
animals were dosed with a unique dose of 200 mg/kg bw under
semiocclusive coverage for 24 hours, and observed for toxicity and
pharmacological effects at 1, 2 and 4 hours post-dose and once daily for
14 days. All animals were also observed twice a day for mortality and
body weights were recorded pretest, weekly and at termination. At
termination, all animals were examined for gross pathology and abnormal
tissues were preserved in 10% neutral buffered formalin for possible
future histological examination. All Animals survived the 200 mg/kg bw
dermal application of the test substance. Only one animal of the first
study appeared lethargic on the day of treatment (Day 0). There were no
further adverse clinical effects and body weight changes were normal in
both studies. Severe dermal effects (necrosis) were observed after 24
hours, on days 11 and 14, and at necropsy. No further adverse effects
were observed at necropsy. Therefore, based on the observed results, the
dermal LD50 of test substance after acute dermal application to rabbits
appeared to be greater than 200 mg/kg bw.
The acute dermal toxicity of the test substance (TS purity >97%)
was also evaluated in rabbits in a test protocol conducted similar to
the OECD TG 402 with acceptable deviations (BASF SE, 1977). 3 male and 3
female rabbits were treated with 190 mg/kg bw test substance applied to
a haven skin site on their back for 24 h under occlusive conditions. The
animals were observed for 14 days for mortality and clinical signs of
toxicity, and those animals that died during the course of the study
were submitted to necropsy. Survived animals were also subjected to
gross-pathological examination. One male animal was found dead within 48
hours after treatment and a total of 3 animals (2 males and 1 female)
died up to the end of the observation period. Clinical signs of toxicity
included apathy, dispnoea, cyanosis, tremor, piloerection,
blood-coloured urine with hematoma and poor general state. Local signs
of irritation included erythema, edema, necrosis and desquamation
observed in all animals. Based on the results of the study an acute
dermal LD50 of approx. 190 mg/kg bw after administration of test
substance to rabbits.
Taken together all data the acute dermal LD50 is estimated to be
greater than 200 mg/kg bw.
No reliable data available. One disregarded study done by BASF in
1977 is available.
The animals were exposed to the saturated vapours generated from a test
substance with very low vapour pressure. The nominal concentration and
saturated concentration (calculated) was approximately 0 mg/L indicating
that the animals were not exposed to the vapours. Analytical
verification of the test atmosphere was not performed. Keeping in view
these methodological deficiencies, the study was considered to be not
reliable for the assessment.
Justification for selection of acute toxicity – oral endpoint
Only one study available.
Justification for selection of acute toxicity – dermal endpoint
Based on the oral LD50, the
test substance has to be classified according to EU Annex VI of
directive 67/548/EEC (Xn, R22) and 1272/2008/EEC (Cat 4) for the oral
Based on the dermal LD50,
the test substance has to be classified according to EU Annex VI of
directive 67/548/EEC (T, R24) and 1272/2008/EEC (Cat 3) for the dermal
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