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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 05 December 2000 and 21 December 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with OECD guidelines and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Description: colorless liquid
Quantity and container: two brown glass flasks containing 800 g each
Storage conditions: at room temperature and protected from light
Purity: 98.91 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals
Sex, species, strain: male New Zealand White rabbits.
Reason for this choice: species generally accepted by regulatory authorities for this type of study.
Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animals: three animals were used, as recommended by the international guidelines.
Weight on the day of treatment, the animals had a mean body weight ± standard deviation of 2.4 ± 0.1 kg.
Acclimation: at least 5 days before the beginning of the study.
Identification: individual metal ear tag.

Environmental conditions
The conditions in the animal room were set as follows:
temperature: 20 ± 3°C
relative humidity: 30 to 70%
light/dark cycle: 12 hlI2 h
ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these daily checks, the housing conditions and corresponding instrumentation and equipment were verified and calibrated at regular intervals.
The animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
Each cage was equipped with a food container and a water bottle.

Food and water
During the study, the animals had free access to 110 and 112 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France).
Food is analysed regularly by the supplier for composition and contaminant levels.
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories.
These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines).
No contaminants were known to have been present in the diet or drinking water at levels which may be expected to have interfered with or prejudiced the outcome of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated skin served as control.
Amount / concentration applied:
0.5 ml of the undiluted test substance
Duration of treatment / exposure:
3 minutes and/or 4 hours
Observation period:
Up to 15 days
Number of animals:
3
Details on study design:
Preparation and selection of the animals
The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined. Only animals with healthy intact skin were used.
Application of the test substance
As possible irritant effects were anticipated, the test substance was evaluated on a single animal (No. 59) in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
Since the test substance was not severely irritant on this first animal, it was then applied for 4 hours to two other animals (Nos. 71 and 72 ).
Doses of 0.5 ml of the undiluted test substance were placed on a dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals.
The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
The untreated skin served as control.
No residual test substance was observed on removal of the dressing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal: 59
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: Day 7
Remarks on result:
other: 3 minute exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal: 59
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Remarks on result:
other: 3 minute exposure, dryness of the skin noted at Days 5 to 13
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal: 59
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: Day 7
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal: 71
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: Day 15
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal: 72
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal: 59
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Remarks on result:
other: 4 hour exposure, dryness of the skin noted at Days 5 to 13
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal: 71
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Remarks on result:
other: 4 hour exposure, dryness of the skin noted at Days 5 to 15
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal: 72
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No evidence of skin irritation
Remarks on result:
other: 4 hour exposure, dryness of the skin noted at Days 5 to 15
Irritant / corrosive response data:
After a 3-minute exposure (one animal):
A very slight or well-defined erythema (grade 1 or 2) was observed from day 2 to day 6. A dryness of the skin was also noted from day 5 to day 13.

After a 4-hour exposure (three animals):
A very slight or well-defined erythema (grade 1 or 2) was noted in all animals from day 1 up to day 6, 10 or to the end of the observation period (day 15).
A dryness of the skin was also recorded in all animals from day 5 to day 13 (one animal) or 15.

Mean scores over 24, 48 and 72 hours for each animal were 1.7, 2.0 and 2 .0 for erythema and 0.0, 0.0 and 0 .0 for oedema.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study and the evaluation criteria as set out in the DSD 67/548/EC, the test substance Vivaldie is irritant when applied topically to rabbits .
Executive summary:

The potential of the test substance Vivaldie to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (92/69/EEC, B.4, 31st July 1992) guidelines. In the first instance, the test substance was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test substance was not severely irritant on this first animal, it was then applied for 4 hours to two other animals. A single dose of 0.5 ml of the undiluted test substance was applied to the closely-clipped skin of one flank.

The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the end of the observation period. Mean scores over 24, 48 and 72 hours for each animal were 1.7, 2.0 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema. Under the experimental conditions of this study and the evaluation criteria as set out in the DSD 67/548/EC, the test substance Vivaldie is irritant when applied topically to rabbits.