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EC number: 202-216-2
CAS number: 93-08-3
Table 3: Individual body weight, body
weight changes and pre-terminal deaths
Group and Dose
(mg/kg body weight)
Body weight (g)
(Day 1 - at
(day 8 – Initial)
(day 15 – Initial)
DRF: Dose Range Finding F: Female
Table 4: Individual test item
application, clinical signs, skin reaction and necropsy findings
Dose range finding study
Date and time
Observation and skin reaction
G1 and 200
Group & Dose
Table 5:Dose range finding study
G2 and 1000
Table 6:Dose range finding
G3 and 2000
Table 7:Main study
10.1 AM and 10.4 AM
NAD: No abnormality detected
Ed: Edema Score
0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as
per Draize method (approximately 24, 48 and 72 hours) after test patch
The acute dermal toxicity study was
conducted to assess the toxicological profile of the test item as per
OECD Guideline 402 (Acute Dermal Toxicity) in Wistar rats.
The test item at the dose of 200, 1000
and 2000 mg/kg body weight was transferred on to the cotton gauze and
applied directly (semi-occlusive) to the clipped skin of the animal to
cover about 10% of the body surface of the rat It was secured in
position by adhesive tape wound around the torso. The test item contact
period with the skin was for 24 hours. There were no clinical signs of
toxicity and pre-terminal deaths.
All the rats were observed for
clinical signs of toxicity and mortality for 14 days post application.
In addition, the treatment site was observed for skin reactions at 24,
48 and 72 hours after removal of test item using the Draize criteria.
There were no clinical signs of toxicity and mortality observed. There
was no skin reaction observed at test item applied area. Body weight was
measured on days 1, 8 and 15 and all rats gained weight during
experimental period. At the end of observation period, all surviving
animals were euthanized and subjected to necropsy. There were no
abnormalities detected at the necropsy.
Based on the results of the present
study, the LD50 value of the given test chemical is >2000 mg/kg bw.
Thus, the test item is not classified for acute dermal toxicity. CLP
criteria "Not Classified".
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