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ACUTE DERMAL IRRITATION STUDY OF POLYHERBAL GEL MASTILEP IN RABBITS

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Objective: The current study was designed to study Acute Dermal Irritation potential of Mastilep gel (supplied by M/S Ayurvet Limited, Baddi, India) according to OECD guidelines. Materials and Methods: Mastilep gel, a new herbal ointment for topical use applied on the udder, has been developed as an alternative method for controlling mastitis in ruminants. Mastilep gel " s active ingredients including herbal extracts of Cedrus deodara, Curcuma longa, Glycyrrhiza glabra and Eucalyptus globulus are expected for their antibacterial, anti-inflammatory, analgesic, antihistaminic and immunomodulatory effects. For new substances it is the recommended stepwise testing approach for developing scientifically sound data on the corrosivity/irritation of the substance. Three female rabbits were used for the study. Each animal served as its own control. After application of Mastilep gel the degree of irritation/corrosion was read and scored. Results: No severe erythema, oedema or any skin lesion was observed after Mastilep gel application. The results revealed no irritation potential of Mastilep gel. Conclusion: MASTILEP gel is safe for usage.
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Gatne et al., IJPSR, 2015; Vol. 6(8): 3473-3476. E-ISSN: 0975-8232; P-ISSN: 2320-5148
International Journal of Pharmaceutical Sciences and Research 3473
IJPSR (2015), Vol. 6, Issue 8 (Research Article)
Received on 25 December, 2014; received in revised form, 17 March, 2015; accepted, 05 May, 2015; published 01 August, 2015
ACUTE DERMAL IRRITATION STUDY OF POLYHERBAL GEL MASTILEP IN RABBITS
M. M. Gatne 1, K. Tambe 1, Adarsh *2 and K. Ravikanth 2
Department of Pharmacology and Toxicology 1, Bombay Veterinary College, Parel, Mumbai (M.S.) India
Clinical Research 2, Ayurvet Limited, Baddi, 173205, Himachal Pradesh, India
ABSTRACT: Objective: The current study was designed to study Acute
Dermal Irritation potential of Mastilep gel (supplied by M/S Ayurvet
Limited, Baddi, India) according to OECD guidelines. Materials and
Methods: Mastilep gel, a new herbal ointment for topical use applied on the
udder, has been developed as an alternative method for controlling mastitis
in ruminants. Mastilep gel‟s active ingredients including herbal extracts of
Cedrus deodara, Curcuma longa, Glycyrrhiza glabra and Eucalyptus
globulus are expected for their antibacterial, anti-inflammatory, analgesic,
antihistaminic and immunomodulatory effects. For new substances it is the
recommended stepwise testing approach for developing scientifically sound
data on the corrosivity/irritation of the substance. Three female rabbits were
used for the study. Each animal served as its own control. After application
of Mastilep gel the degree of irritation/corrosion was read and scored.
Results: No severe erythema, oedema or any skin lesion was observed after
Mastilep gel application. The results revealed no irritation potential of
Mastilep gel. Conclusion: MASTILEP gel is safe for usage.
INTRODUCTION: Mastitis is the inflammation
of mammary gland with physical, chemical and
microbiological changes characterized by an
increase in somatic cells in the milk and by the
pathological changes in the mammary tissue 1.
Mastilep gel is a novel approach to control mastitis
and applied to the teats of the affected cattle 2. As
animal skin is quite sensitive for most of the
chemicals thus all new formulations must be tried
on skin for a specified period of time to check any
irritation or erythema. Allergic, irritant contact
dermatitis and phytophotodermatitis are included
among the topical adverse effects of natural
products 3. Hence it is very important to study
dermal toxicity of Mastilep gel in vivo.
QUICK RESPONSE CODE
DOI:
10.13040/IJPSR.0975-8232.6(8).3473-76
Article can be accessed online on:
www.ijpsr.com
DOI link: http://dx.doi.org/10.13040/IJPSR.0975-8232.6(8).3473-76
MATERIAL AND METHODS:
The animals for the current study were approved by
IAEC (MVC/IAEC/30/2014). Healthy 12 months
old 3 female New Zealand white Rabbits (body
weight 2.5 kg) rabbits were used. Animals were
kept under acclimatization for eight days before
application. A day prior to start of the study, the
rabbits were weighed. The animals were identified
by appropriate identification mark. The cage was
provided with a card showing the details of cage
number, test formulation, animal number, sex of
the animal and the study number. Housing
conditions were conventional. The ambient
temperature was 25oC and relative humidity of 70
%. The animals were exposed to 12 hour light/dark
cycle and provided with standard diet and water ad
libitum. 4
Preparation of the animals:
Approximately 24 hours before the test, fur was
removed by closely clipping the dorsal area of the
trunk on either side of spinal cord of the animals.
Keywords:
Mastilep gel, OECD,
Acute Dermal Irritation
Correspondence to Author:
Adarsh
Trainee - Clinical Research &
Development, Research &
Development devision, Ayurvet
Limited, Baddi, H.P., India
E-mail- clinical@ayurvet.in
Gatne et al., IJPSR, 2015; Vol. 6(8): 3473-3476. E-ISSN: 0975-8232; P-ISSN: 2320-5148
International Journal of Pharmaceutical Sciences and Research 3474
Care was taken to avoid abrading the skin, and an
only animal with healthy, intact skin was used. The
test substance (MASTILEP) was applied in a single
dose (0.5 gm) to the skin (approximately 6 cm2) of
an experimental animal and covered with a gauze
patch (right side of the trunk).
Untreated skin areas (left side) of the test animal
serve as the control. Rabbits were exposed to the
test drug for period of one hour. The degree of
irritation/corrosion was read and scored (Table 1) 5
at specified intervals and was further described in
order to provide a complete evaluation of the
effects.
In addition to the observation of irritation, all local
toxic effects, such as defatting of the skin, and any
systemic adverse effects (e.g., effects on clinical
signs of toxicity and body weight), were fully
recorded. The skin patch of the each rabbit was
closely observed and recorded twice a day. Data
was recorded at interval of 24hr, 48hr and 72hr
after patch removal.
TABLE 1: GRADING OF SKIN REACTIONS
Erythema and Eschar Formation
No erythema
Very slight erythema (barely perceptible)
Well defined erythema
Moderate to severe erythema
Severe erythema to eschar formation
preventing grading of erythema
Maximum possible: 4
Oedema Formation
No oedema
0
Very slight oedema (barely perceptible)
1
Slight oedema (edges of area well defined by
definite raising)
2
Moderate oedema (raised approximately 1
mm)
3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure)
4
Maximum possible: 4
RESULTS:
Erythema: Erythema is redness of the skin or
mucous membranes, caused by hyperemia of
superficial capillaries 6. After 24hr redness was
observed in one out of three rabbits when compared
with control. After 48hrs there were no any
changes observed. (Table 2)
Oedema: Edema means swelling caused by fluid in
body's tissue. Though herbs are Novel Anti-
inflammatory Agents 7 but for a new dermal
formulation its irritation potential should be
evaluated. The results revealed that there were no
edematous lesions at any time of the observation
(Table 3). The data obtained from the study on last
day of test compound did not reveal any lesion.
TABLE 2: GRADING OF ERYTHEMA AND ESCHAR
FORMATION AT DIFFERENT TIME INTERVALS IN
EXPERIMENTAL RABBITS
Animal ID
Grading and time intervals
24 hr.
48hr
72hr
I
1
0
0
II
0
0
0
III
0
0
0
TABLE 3: EDEMA FORMATION AT DIFFERENT
TIME INTERVALS IN EXPERIMENTAL RABBITS
Animal ID
Grading and time intervals
24 hr.
48hr
72hr
I
0
0
0
II
0
0
0
III
0
0
0
Skin observations:
Fig. 4 showed that there was redness at 24 hr time
interval in one out of three rabbits when compared
with control Fig.3. After 48hrs there were no any
changes observed. From Fig.1 to 8 it was evident
that there was no significant difference in control
and test groups at different time intervals. Other
skin lesions like defatting of skin, adverse skin
reactions, local systemic changes etc. were not
observed at any time of the observations.
FIG. 1: CONTROL (0HRS)
FIG. 2: TEST (0HRS)
Gatne et al., IJPSR, 2015; Vol. 6(8): 3473-3476. E-ISSN: 0975-8232; P-ISSN: 2320-5148
International Journal of Pharmaceutical Sciences and Research 3475
FIG.3: CONTROL (24HRS)
FIG. 4: TEST (24HRS)
FIG. 5: CONTROL (48HRS)
FIG. 6: TEST (48HRS)
FIG. 7: CONTROL (72HRS)
FIG. 8: TEST (72HRS)
DISCUSSION: Assessing risk is a function of
hazard and exposure data. For new substances
introduced into the marketplace, it is the
recommended stepwise testing approach for
developing scientifically sound data on the
corrosivity/irritation of the substance 8, 9. Some
plant extract active ingredients reported to possess
toxicological potential 10. In current experiment the
Acute Dermal Irritation study of polyherbal gel
MASTILEP in rabbits was conducted. Dermal
Irritation is the production of reversible damage of
the skin following the application of a test
substance 11. No signs of skin corrosivity/irritation
were observed on Mastilep gel application this may
be because of its herbal constituents like Cedrus
deodara, Curcuma longa, Eucalyptus globulus
reported to posses anti inflammatory and wound
healing potential 12, 13, 14.
CONCLUSION: Based on the analysis of all the
available parameters studied it is concluded that
MASTILEP gel was tolerated in experimental
rabbits and there were no skin lesions in animals up
to 72hr time interval. The overall observations
indicated that MASTILEP gel did not cause any
severe inflammatory changes in given skin
irritation test.
ACKNOWLEDGEMENT: The authors are
thankful to Ayurvet Limited, Baddi, India and
Department of Pharmacology and Toxicology,
Bombay Veterinary College, Parel, Mumbai for
providing the required facilities, guidance and
support.
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Gatne MM, Tambe K, Adarsh and Ravikanth K: Acute Dermal Irritation Study of Polyherbal Gel Mastilep in Rabbits. Int J Pharm Sci Res
2015; 6(8): 3473-76.doi: 10.13040/IJPSR.0975-8232.6(8).3473-76.
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This article can be downloaded to ANDROID OS based mobile. Scan QR Code using Code/Bar Scanner from your mobile. (Scanners are available on Google Playstore) How to cite this article: Gatne MM, Tambe K, Adarsh and Ravikanth K: Acute Dermal Irritation Study of Polyherbal Gel Mastilep in Rabbits. Int J Pharm Sci Res 2015; 6(8): 3473-76.doi: 10.13040/IJPSR.0975-8232.6(8).3473-76.