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EC number: 276-380-9
CAS number: 72140-65-9
Two acute oral and one acute dermal toxicity studies were conducted on
MTDID 15670. The result of the studies were:
The rat oral LD50 is between 300-2,000 mg/kg body weight when tested
according to OECD 423 (2001).
The rat oral LD50 is greater than 2,000 mg/kg body weight when tested
according to OECD 401 (1987).
The rat dermal LD50 is greater than 2,000 mg/kg when tested according to
OECD 402 (1987).
Acute Oral Lethality:
The acute oral lethality of the test article was determined in rats.
Female Wistar rats received 300 mg/kg (6 females) or 2000 mg/kg (3
females) test article dissolved in DMSO via oral gavage. Observations
for mortality (recorded twice daily), body weights (day 1, 8, 15 or at
death), clinical signs (once daily), and macroscopic examination (at
necropsy). At 2000 mg/kg all animals exhibited clinical signs of
toxicity including lethargy (3/3), spasms (3/3), abnormal and/or hunched
posture (3/3), abnormal gait (3/3), uncoordinated movements (2/3),
ventro-lateral recumbency (1/3), loss of righting reflex (1/3),
increased activity (1/3), hypotonia (1/3), deep breathing (1/3),
piloerection (3/3), shaking head (1/3), paleness (1/3), salivation
(1/3), dehydration (2/3), and ptosis (3/3). On Day 2 one animal in the
2000 mg/kg group was euthanized for humane reasons after exhibiting
symptoms including lethargy, tremors, and pale and lean appearance.
Another animal was found dead on Day 4 in this dose group. These two
animals had reduced spleen sizes, and gastrointestinal distension upon
post mortem examination. At the 300 mg/kg animals exhibited piloerection
and hunched posture (6/6), lethargy (3/6), ptosis (3/6), rales (1/6),
and slow breathing (1/6) between Days 1 and 8. No mortality was seen at
this dose level, however, and only one animal had gastrointestinal
distention due to gas noted on necropsy. Based on the results of the
study, the rat oral LD50 of the test article is between 300 -2000 mg/kg
Male and female Wistar rats (3/sex/dose) were exposed to 2000 mg/kg bw
MTDID 15670 (Flunit) in 10 mL 4% CMC sodium salt purum in a single oral
gavage dose. Animals were fasted for 12 -18 hours prior to gavage and
for one hour post dosing. Over the 15 day observation period, body
weights (day 1, 8 and 15), clinical signs (1, 2, 3 and 5 hours post
dosing and once daily for remaining observation period), and macroscopic
organ examination (at necropsy) findings were recorded. On day 15 all
surviving animals were necropsied. No unscheduled mortality occurred.
Body weight was not affected by exposure and no macroscopic findings
were noted at necropsy. Males receiving 2000 mg/kg bw MTDID 15670 showed
no clinical signs of toxicity. Females recieving 2000 mg/kg bw MTDID
15670 showed hunched posture (1), ventral recumbancy (1), ruffled fur
(2), sedated behavior (2), and spasms (1). Based on these results, the
rat oral LD50 for MTDID 15670 is > 2000 mg/kg bw.
Acute Dermal Lethality:
MTDID 15670 was administered to five Wistar rats of each sex by a single
dermal application at 2000 mg/kg body weight for 24 hours. Animals were
subjected to daily observations and weekly determination of body weight.
Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred. Chromodacryorrhoea and/or ptosis were noted for
most animals on Day 1. The changes noted in body weight gain in males
and females were within the range expected for rats used in this type of
study and were therefore considered not indicative of toxicity. No
abnormalities were found at macroscopic post mortem examination of the
animals. Based on the results of the study, the dermal LD50 in rats was
> 2000 mg/kg bw for MTDID 15670.
Based on the results of the studies, the test article meets the criteria
for acute oral lethality GHS Category 4 and does not
meet the GHS classification criteria for acute dermal lethality.
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