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EC number: 214-881-6
CAS number: 1205-17-0
The calculated acute oral LD50 in female rats was 3362 mg/kg with 95 %
confidence limits of 3002 to 3766 mg/kg.
The LD50 value was found to be greater than 2000 mg/kg of body weight in
male and female rabbits.
The potential of the test material to cause acute toxicity via the oral
route was investigated using methodology equivalent or similar to the
standardised guideline OECD 401 under GLP conditions.
Following a dose range-finding study, six groups of ten Sprague Dawley
rats (five males and five females) were administered the test material
at dose levels of 1600, 2000, 2500, 3200, 3600 and 4000 mg/kg in 0.25 %
methylcellulose. The rats were observed immediately and at one and four
hours after dosing and twice daily for fourteen days for
pharmacotoxicity, CNS effects and mortality. Body
weights were recorded on the 14th day. The surviving rats were
sacrificed by CO2 inhalation and a gross necropsy performed. The
statistical method used was the method of Litchfield and Wilcoxon.
Signs observed included episodes of increased or decreased activity,
nasal discharge, diarrhoea, salivation, lacrimation, ptosis,
chromodacryorrhea, dyspnoea, decreased muscle tone, abnormal gait,
abnormal stance and prostration. None of the rats died at 1600, 2000 or
2500 mg/kg; two of ten died at 3200 mg/kg, four of ten died at 3600
mg/kg and ten of ten died at 4000 mg/kg. Necropsy of the animals dying
on study revealed distended stomachs, lesions in the stomach mucosa and
fluid-filled intestines. Congested, bright red lungs and foci on the
kidneys were also observed. No visible lesions were observed in any of
the remaining animals at terminal necropsy.
The calculated acute oral LD50 in male and female rats was determined to
be 3561 mg/kg with 95 % confidence limits of 3246 to 3906 mg/kg and a
slope of 1.11. The calculated acute oral LD50 in females was determined
to be 3362 mg/kg with 95% confidence limits of 3002 to 3766 mg/kg and a
slope of 1.1. An attempt was made to calculate the LD50 in males but the
data generated did not lend itself to the method of Litchfield and
Under the conditions of the study, the LD50 in female rats was
determined to be 3362 mg/kg with 95 % confidence limits of 3002 to 3766
Table 1: Body weight, dose volume and dermal reactions
Ear tag # & Sex
Dose volume (cc)
Body Weight (kg) on Day
Skin Reactions on Day
†Body weight verified. This animal died on day 12 with a
terminal body weight of 1.9 kg
E = erythema (redness)
a = dose site stained yellow
f = flaking skin
* = animal re-clipped
% Rem. = a visual estimate of the amount of material
remaining on the skin, gauze and occlusive binding at 24 hours, after
the occlusive binding was removed.
The potential of the test material to cause acute dermal toxicity in the
rabbit was investigated in accordance with the standardised guideline
OECD 402 under GLP conditions.
Five healthy male and five healthy female New Zealand Albino rabbits
were dosed dermally with the test material at 2000 mg/kg of body weight.
The test material was applied to intact skin and covered in an occlusive
fashion for 24 hours. at the end of the exposure period, the test
material was gently washed off with distilled water.
Animals were observed for toxicity and pharmacological effects at 1, 2
and 4 hours post dosing and once daily up to 14 days. Body weights were
recorded pre-test, weekly and at death or termination. The animals were
observed twice daily for mortality. The test sites were scored for
dermal irritation at 24 hours post dose and on days 7 and 14 using the
numerical Draize scale. All animals were examined for gross pathology.
Nine out of ten animals survived the 2000 mg/kg dermal application. One
male rabbit died on day 12 and exhibited pre-death physical signs of
diarrhoea, lethargy and few faeces.
The nine out of ten animals that survived the 2000 mg/kg dermal
application experienced instances of diarrhoea. Dermal reactions, absent
to well defined on day 1 were absent on days 7 and 14. Body weight
changes were normal in all survivors.
Necropsy of the dead animal revealed abnormalities of the treated skin,
lungs, pleural cavity and gastrointestinal tract. The death did not
appear to be related to the treatment with the test material but to a
pulmonary infection. Necropsy results were normal in eight out of the
nine surviving rabbits. One female exhibited liver abnormalities
(nodules on liver).
Under the conditions of this study, the LD50 value was found to be
greater than 2000 mg/kg of body weight.
Acute Oral Toxicity
In accordance with the Column 2 adaptation in Section 8.5 of Annex VIII
of Regulation (EC) No 1907/2006 (REACH), it is considered justified to
omit the acute toxicity testing by the inhalation route on the grounds
that oral and dermal exposure are more likely.
Acute dermal toxicity
In accordance with the criteria for classification as defined in Annex
I, Regulation (EC) No 1272/2008, the substance does not require
classification with respect to acute toxicity.
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