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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): RPA 405217, product : Dimethyl Benzylidène Cyclo Pentanone
- Substance type: yellowish powder
- Analytical purity: 96.5 %
- The pH of the test substance in solution at 1% in 0.9% NaCl, measured at C.I.T. was 4.70.
- Purity test date: 13.01.1992
- Lot/batch No.: 07/W
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole du Val de Seile, 80160 Prouzel, France
- Weight at study initiation: 2.7 ± 0.2 kg
- Housing: The animals were individually housed in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cmn). Each cage was equipped with a food container and a water bottle
- Diet: During the study, the animals were fed ad libitum with a certified pellet diet (Rabbits sustenance ref. 112 C" (U.A.R., 91360 Villemoisson-sur-Orge, France). An analytical certificate of the quality of the food and the major food contaminants (pesticides, heavy metals, mycotoxins, etc.) was made available by the supplier und given for each batch
- Water: During the study, the animals had free access to tap water filtered by a 0.22 micron filter membran and contained in water bottles. Bacteriological und chemical analyses of the water und detection of the major contaminants (pesticides, heavy metals und nitrosamines) were made periodically
- Acclimation period: Upon their arrival. at C.I.T., the animals were acclimatized to the experimental environment for at least 5 days during which they were observed daily. The animals received a preventive treatment for coccidiosis by administration of a Mucoxid solution at the dose level of 137.5 mg/kg bw/day at a volume of 10 ml/kg to their drinking water tor 5 days during the acclimatisation period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity: 50 ± 20 % relative humidity
- Air : The air was non-recycled

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: The left flank did not receive any substance and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg

VEHICLE
- Amount applied: the test substance in its original form was applied to a 6 cm² hydrophilic gauze patch (Semes France, 54183 Heillecourt, France)
pre-moistened with 0.5 ml of vater for injections and this was then applied to the right flank of each animal.
- Lot/batch no. (if required): Water for injections batch No. 1336 (Biosédra, 92240 Malakoff, France) was used in order to disperse the test substance for cutaneous application
Duration of treatment / exposure:
- The test substance and the gauze patch were held in contact with the skin for 4 hours by means of an adhesive hypoallergic aerated semiocclusive
dressing (Laboratoires de Pansements et d'Hygibne, 21300 Chenove, France) attached to a restraining bandage (Laboratoires 3M Santé, 92245 Malakoff, France).
- Subsequently, the dressings were removed and residual test substance was removed with a gauze patch saturated with water for injections batch
No. 1328 (Biosédra, 92240 Malakoff, France). The animals were then placed back into their individual cages.
Observation period:
The single application was performed on the 3.12.91 (day 1).
The animais were kept under observation until the 6.12.91 (day 4).
Number of animals:
- 3
Details on study design:
TEST SITE
- Area of exposure: clipped right flank
- % coverage: semiocclusive
- Type of wrap if used: hydrophilic gauze patch held in contact with the skin for 4 hours by means of an adhesive hypoallergic aerated semiocclusive
dressing (Laboratoires de Pansements et d'Hygibne, 21300 Chenove, France) attached to a restraining bandage (Laboratoires 3M Santé, 92245 Malakoff, France)

REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was removed with a gauze patch saturated with water for injections


SCORING SYSTEM:

The cutaneous reactions were evaluated one hour then 24, 48 and 72 hours after removal of the semiocclusive dressing according to the scoring system laid down in OECD Guideline No. 404.

Animals showing no further cutaneous reactions after 72 hours were no longer kept under observation.
Any other lesion was noted

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0.3
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
A very slight erythema was observed in one animal 1 hour after removal of the dressing.
No edema was noted.
Other effects:
No other cutaneous reactions were observed during the study.

Applicant's summary and conclusion

Executive summary:

In a dermal irritation study according to OECD Guideline 404 a single dose of 500 mg (E)-5[(4 - chlorophenyl)methylene]-2,2 - dimethylcyclopentanone

(95.6 %) was administered to 3 male New Zealand White rabbits in its original form to a 6 cm² clipped area (Rhone-Poulenc, 1992). The test substance was held in contact with the skin for 4 hours by means of an adhesive hypoallergic aerated semiocclusive dressing. Residual test substance was removed by means of a compress saturated with water. The cutaneous reactions were observed one hour, 24, 48 and 72 hours after removal of the dressing according to the scoring system laid down in OECD Guideline No. 404.

A very slight erythema was observed only in one animal 1 hour after removal of the dressing. No edema was noted. No other cutaneous reactions were observed during the study.

Thus, the test substance was considered as non-irritant when administered by cutaneous route in rabbits.