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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:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Weight at study initiation: 2.5 kg
- Housing: the rabbits were individuallyhoused in polystyrene cages (0,35 x 0,55 x 0,32 m). Each cage was equipped with a food container and a water bottle.
- Diet: the animals were fed ad libitum with a certified pelleted diet Rabbit Diet SQC (Special Diets Services Ltd, Nitham, Essex, England) during the study. Analytical results for major food contaminants (pesticides, heavy metals, mycotoxins, etc..) were made available by the supplier.
- Water: the animals had free access to tap water filtered with Millipore filters, in water bottles.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 50 ± 20 %
- Air changes: the animals were maintained in an air conditioned room. The incoming, non-recycled air, was filtered by an absolute filter (0.3 micron).
- Photoperiod: the light/dark cycle was 12 hours per day.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of the test sample

Duration of treatment / exposure:
4 hours
Observation period:
A single application was followed by an observation period of three days.
Number of animals:
6 males
Details on study design:
TEST SITE
-Area of exposure: 6 cm²
-Type of wrap if used: covered by a hydrophilic patch Codex moistened with some drops of distilled water (lot n° 1145, Biosédra, 92240 Malakoff, France) to prevent loss of material, and held in contact with the skin.

REMOVAL OF TEST SUBSTANCE
-Washing (if done): the patch was taken off and the residual test sample was removed by means (Hi a gauze saturated with sterile pyrogen-free water.

SCORING SYSTEM
Erythema and Eschar Formation
No erythema:0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised more than 1 mm and extending beyond area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1.#2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal: #1.#2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Other effects:
-Mortality:
No mortality was observed

-Clinical signs
No cutaneous reaction erythema or oedema was noted during the study

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The substance was found to be not irritating for rabbit skin.
Executive summary:

The acute dermal irritation potential of the test item was evaluated in an in vivo study according to the OECD Guideline 404 (1981). 0.5 g of test item was applied on the clipped skin of six rabbits using a semi-occlusive patch; the right flank untreated was used as control.

No cutaneous reaction was observed. The erythema and oedema scores (mean values 24/48/72 h) were 0 in all animals.