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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:
05 February - 12 February 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 1992
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kißlegg
- Age at study initiation: about 22 weeks
- Weight at study initiation: 3.01 - 3.91 kg
- Housing: separately in special rabbit cages (manufacturer: Becker; type
K99/30 KU, floor area about 5400 cm2
- Diet: ad libitum (Altromin Standard Diet TPF(R) 2113, pellets)
- Water: ad libitum (tap water)
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22
- Humidity (%): 54 to 75
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:
4 hours
Observation period:
Skin alterations, behaviour, and general conditions were observed 1 hour, 24, 48, 72 hours after patch removal, and then daily up to day 8.

Bodey weight was recorded on day 1 and on days 5 and 8.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: self-adhesive fabric

REMOVAL OF TEST SUBSTANCE
- Washing: any test material left was wiped off
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Skin alterations, behaviour, and general conditions were observed 1 hour, 24, 48, 72 hours after patch removal, and then daily up to day 8.

Bodey weight was recorded on day 1 and on days 5 and 8.

SCORING SYSTEM:
- Method of calculation: according to DRAIZE scheme and OECD Guideline

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:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
- Other adverse local effects: no
- Other adverse systemic effects: no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, no signs of irritation were seen. Thus, the test item is not considered to be irritating to rabbits' skin.
Executive summary:

To investigate the potential for primary skin irritation, 0.5 g of the test material were mixed with a few drops of Aqua pro injectione to ensure good contact to the skin, spread onto patches, and then applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then, examinations were performed daily for another 7 days.

The individual mean scores (considering readings 24, 48, and 72 hours after patch removal) of each animal were 0 for erythema and edema. Furthermore, no signs of systemic toxicity, no mortality and a normal body weight gain were observed.

Under the conditions of the present study, the test item is not considered to be irritating to skin.