Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-05-16 to 2006-05-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study reliable without restrictions Minor deviations with no effects on the study: - According to the guideline, for the initial test in one animal, the test site is also examined immediately after the patch has been removed. In this study report there was no statement indicating if this was done. - According to the guideline a rationale for in vivo testing should be stated in the study report. This is missing in this study report. - According to the guideline, the individual animal weights at the start and at the conclusion of the test should be stated. In this study report only a mean body weight with standard deviation was stated, which only indicated the mean body weight at the beginning of the study.. - According to the guideline, in the test report the volume of vehicle used should be stated. This was missing in this study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
yes
Remarks:
Minor deviations with no effect on the study (see rationale for reliability)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Peconal H
- Physical state: Pink powder
- Storage condition of test material: At room temperature and under argon gas
- The pH of the test item was not measurable (test item not soluble in water)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: On the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: On the day of treatment, the animals had a mean body weight +/- standard deviation of 2.5 +/- 0.1 kg
- Housing: The animals were housed individually in Pajon (50 cm X 57 cm X 75 cm) cages. Each cage was equipped with a food container and a water bottle.
- Diet: During the study, the animals had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Relative humidity: 30 to 70 %
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test item
No further information on amount/concentration applied was stated.
Duration of treatment / exposure:
One animal : 3 minutes, 1 hour and 4 hours
Other animals: 4 hours
Observation period:
Observation period was 1 hour, 24, 48 and 72 hours after removal of the dressing. The study was ended on day 4.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
The day before treatment, both flanks of each animal were clipped using electric clippers. Doses of 500 mg of the test item in its original form were placed on a gauze pad moistened with purified water, which was then applied to an area of approximately 6 cm^2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wiped off by means of a dry cotton pad.

SCORING SYSTEM:
Draize scoring system
No further information on details on study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24,48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No erythema was observed.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal # 1
Time point:
other: 24,48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No oedema was observed.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal # 2
Time point:
other: 24,48 and 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No oedema was observed.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal # 3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No erythema was observed.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal # 3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No oedema was observed.
Irritant / corrosive response data:
After a 3 minute exposure (one animal):
No cutaneous reactions were observed.
After 1 hour exposure (one animal)
An orange colouration of the skin was noted at 1 hour and at 24 hours.
After a 4 -hour exposure (three animals):
A very slight erythema (grade 1 ) was noted in 2/3 animals at one hour; it persisted in one of them at 24 hours.
An orange colouration of the skin was observed in 2/3 animals at 1 hour.

Any other information on results incl. tables

Raw data for 3 -minute exposure:

Rabbit No.

Dermal irritation

1 hour

24 hours

48 hours

72 hours

Mean irritation score

(24 h, 48 h, 72h)

1

Erythema

0

0

0

0

0.0

Oedema

0

0

0

0

0.0

Raw data for 1 hour-exposure:

Rabbit No.

Dermal irritation

1 hour

24 hours

48 hours

72 hours

Mean irritation score

(24 h, 48 h, 72h)

1

Erythema

0

0

0

0

0.0

Oedema

0

0

0

0

0.0

Raw data for 4 hour-exposure:

Rabbit No.

Dermal irritation

1 hour

24 hours

48 hours

72 hours

Mean irritation score

(24 h, 48 h, 72h)

1

Erythema

0

0

0

0

0.0

Oedema

0

0

0

0

0.0

2

Erythema

1

1

0

0

0.3

Oedema

0

0

0

0

0.0

3

Erythema

1

0

0

0

0.0

Oedema

0

0

0

0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the test item Peconal H was very slightly irritant when applied topically to rabbits.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item Peconal H should not be classified as irritating to the skin.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not irritating.