Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 July - 18 August, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 1712.5 g, 1986.5 g, 2081.7 g
- Housing: single, in steel cages with a plastic bottom mould and a habitat of 5445 cm2 at the bottom and an overall height of 600 mm.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): set at 20 +/- 3°C, but temperature was high in general and rose up to 27°C sometimes.
- Humidity (%): set at 30-70%, but was higher than 70% for a short time period.
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19 July 2004 To: 3 August 2004

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the other flank served as control region.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): not applicable
Duration of treatment / exposure:
4 hours
Observation period:
1h, 24h, 48h, 72h and 7 and 14 d after removal of the test substance
Number of animals:
3 (1 male and 2 females); initial test with 1 animal.
Details on study design:
TEST SITE
- Area of exposure: 3x2 cm (i.e. 6 cm2)
- % coverage: 100 %
- Type of wrap if used: gauze pad held in place by strips of Blenderm and bandaged with Acrylastic and fixed with Leukoplast.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD404 and Primary Skin Irritation Index according to Draize (the numerical scores for erythema and edema were added together for each observation period and the greatest value gave the Primary Irritation Index).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Slight erythema but no edema formation were observed. 7 days after application desquamation was observed at the skin of one rabbit, and slight desquamation was still present after 14 days.
Other effects:
No systemic toxic symptoms or abnormal changes in body weight were noted.

Any other information on results incl. tables

primary dermal irritation index (PDII) (mean of three animals): Score: 1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Primary Skin Irritation Index according to Draize was used to classify the test substance as: mildly irritating. However according to the EU criteria, the substance is not irritating to the skin and does not need to be classified for skin irritation.
Executive summary:

The skin irritation potential of the substance was assessed by semi-occluded application of the substance for four hours to the shorn skin of two female and one male rabbit, strain New Zealand White according to OECD Guideline 404. Dermal reactions at the treated skin sites were assessed 1 hour after removal of the test substance and approximately 24, 48 and 72 hours as well as 7 and 14 days later. Systemic toxicity symptoms after application were not observed at any time during the study. Body weight development of the animals was positive and within normal ranges.

The substance elicited slight erythema formation at two animals after 1 hour and 24 hours after removal of the substance which was still observed in one animal after 48 hours. 72 hours after the removal of the substance no more erythema were observed in all three animals. A mean score of 0.67, 0.33 and 0 was allocated. Oedema formation was not observed at any time point.

7 days after application desquamation was observed at the treated skin of one animal. 14 days after application slight desquamation was still existent.