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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
Study period:
2007-11-21 to 2008-03-03
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid, pearl
- Analytical purity: 100%
- Lot/batch No.: T71225
- Expiration date of the lot/batch: 21 March 2009 (re-test)
- Storage condition of test material: at the room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste –F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the animals weighed between 2.36 kg and 3.56 kg. At the beginning of the test, the animals were 11 and
14-week old.
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 19°C and 21°C
- relative humidity : between 40% and 55%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The test item was applied, after being reduced in fine powder, at a dose of 0.5 g in an area of about 6 cm2.
Duration of treatment / exposure:
4 hours
Observation period:
until 72 hours after removal of the patch
Number of animals:
3 rabbits
Details on study design:
Approximately 24 hours before the test, the rabbits’ backs and flanks were shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm2.
The test item was applied, after being reduced in fine powder, at a dose of 0.5 g, on an undamaged skin area of one flank of each animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape. After the removal of the patch, the treated area was rinsed with distilled water.
On the opposite flank an untreated area was served as the control.
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
This examination consists in assessing the irritant reactions in the treated zone, compared to a control area; the following scales are used:
Grading scales :
Erythema and Eschar formation Oedema
0...... No erythema 0 ......No oedema
1...... Very slight erythema (barely perceptible) 1 ......Very slight oedema (barely perceptible)
2......Well defined erythema 2 ...... Slight oedema (contour clearly defined)
3...... Moderate to severe erythema 3 ......Moderate oedema (raised approx. 1mm)
4...... Severe erythema (beef redness) with eschars formation 4 ...... Severe oedema (raised more than 1mm, preventing grading of erythema and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24,
48 and 72 hours).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test substance, according to the scales of interpretation retained:
- is non irritant to skin (PSi = 0) according to the classification established in the Journal Officiel de la République Française dated February 21st, 1982,
- and, must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 “irritant”. No signal word and hazard statement are required.
Executive summary:

The test substance was applied, after being reduced in fine powder, at the dose of 0.5 g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C.D. guideline n° 404 dated April 24th, 2002 and the test method B.4 of the directive n° 2004/73/EC. No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours). The results obtained, under these experimental conditions, enable to conclude that the test substance must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test substance must not be classified in category 2 “irritant”. No signal word and hazard statement are required.