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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:
24 Nov. - 18. Dec. 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes
Remarks:
Landesanstalt für Pflanzenbau und Pflanzenschutz Rheinland Pfalz, Sep 2001

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Weight at study initiation: 3.80 - 4.63 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiaet, about 130 g/animal per day
- Water: ad libitum, tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml, undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull
stretch (adhesive fleece), Beiersdorf AG, semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1:1).
- Time after start of exposure: after the 4 hours of exposure


SCORING SYSTEM: accodring to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: the first 24 hours before the reading
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
Slight eryrthema (grade 1) was observed in two animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema (grade 2), noted in one animal immediately and 1 hour after removal of the patch, decreased to slight erythema after 24 hours.
No other cutaneous reactions were observed during the study.
The cutaneous reactions were reversible in one animal within 24 hours and in two animals within 48 hours after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
under the conditions of the present in vivo study with rabbits the test item was considered to be non-irritating to the skin.
Executive summary:

In-vivo, a skin irritation test was performed with three New Zealand White rabbits, according to OECD guideline 404 and in compliance with GLP (reliability 1). At least 24 hours before substance administration the dorsolateral part of the trunk of the animals was clipped. The untreated skin sites of the animals served as control. A 4-hour semiocclusive exposure to ca. 0.5 ml of the undiluted test substance produced the following effects: slight eryrthema (grade 1) was observed in two animals immediately and 1 hour after removal of the patch and persisted in one animal up to 24 hours. Moderate erythema (grade 2), noted in one animal immediately and 1 hour after removal of the patch, decreased to slight erythema after 24 hours. No other cutaneous reactions were observed during the study. The cutaneous reactions were reversible in one animal within 24 hours and in two animals within 48 hours after removal of the patch.

Based on this study findings the test item was considered to be non iriitating to the skin of rabbits.