Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul 30- Aug 20, 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
The study report was performed according to the OECD Guideline for testing of Chemicals (No. 404), according to the Commission Directive 92/69/EEC and to the recommendations of Draize (1959).
Deviations:
no
Principles of method if other than guideline:
none
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: oily liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 17 weeks
- Weight at study initiation: 3,2 kg (mean)
- Housing: separately in special rabbit cage (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2, a shelter with an integrated sitting board of about 1820 cm2; overall height: 60 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25 °C
- Humidity: 24-63 %
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12/12 hours

IN-LIFE DATES: From: day 1 To: day 8

Test system

Type of coverage:
semiocclusive
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
The first examination of the treated skin sites followed 1 hour after removal of the patch. Thereafter, examinations were performed after 24, 48, and 72 hours and then daily up to experimental day 22.
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100
- Type of wrap if used: self-adhesive fabric mull

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 h

SCORING SYSTEM: Skin changes at the application sites were evaluated according to the DRAIZE-, OECD-and EEC recommendations.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.6
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
0.5 mL of the liquid test material was administered undiluted. After a single application to the intact dorsal skin of a rabbit, for 4 hours under semiocclusive conditions, erythema (scores 1 and 2) and edema (scores 1 and 2) were observed from day 1 up to day 8 ofthe study. Furthermore leathery skin from day 7 up to day 14 and scales from day 12 up to the end of the study were seen.
Other effects:
- Other adverse systemic effects: No clinical signs and no mortality was observed. Body weight development of the treated rabbit was inconspicuous.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The test material revealed a long lasting irritation potential with a remarkable damage of the skin. However, the study cannot used for classification according to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures. Based on the correspondence with the german authority BAuA (2006) the test item should be considered as irritating to skin.
Executive summary:

Summary

Study design

The study was performed similar to the OECD Guideline for Testing of Chemicals, No. 404 and the recommendations of DRAIZE (1959).
To test for primary skin irritation, 0.5 g of the test material was spread onto 6 cm2 patches and applied to the intact skin of a previously shaven rabbit for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 21 days.

Results

The study was started as an initial test with one animal. No signs of pain were observed after administration. After a single application to the intact dorsal skin of a rabbit, for 4 hours under semiocclusive conditions, erythema (scores 1 and 2) and edema (scores 1 and 2) were observed from day 1 up to day 8 ofthe study. Furthermore leathery skin from day 7 up to day 14 and scales from day 12 up to the end of the study were seen. Under the conditions of the present study no signs of irritation were seen.

Evaluation of all animals (mean score)

Day (after treatment)
1
(1 hour)
2
(24 hours)
3
(48 hours)
4
(72 hours)
Erythema 2 2 2 2
Edema 2 2 1 1



Conclusions

The test material revealed a long lasting irritation potential with a remarkable damage of the skin. However, the study cannot used for classification according to Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures. Based on the correspondence with the german authority BAuA (2006) the test item should be considered as irritating to skin.