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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study

Data source

Reference
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
> 98%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
New Zealand albino rabbit
Charles River Deutschland GmbH
88353 Kißlegg
3 animals
3.4 - 3.6 kg b.w. at start of study
numbered ear tags for identification

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Polyethylenglycol 400 (0,5 mL)
Controls:
other: untreated skin
Amount / concentration applied:
500 mg per patch
Duration of treatment / exposure:
4 h
Observation period:
see details on study design
Number of animals:
3 animals
Details on study design:
About 24 hours before the start of the study the hair in the dorsal region of the body of
3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only
animals with intact skin were used.
Each animal was treated with 0.5 g Beta W 7 A 1.0 pasted with 0.5 ml
Polyethylenglycol 400 (Riedel de Haen Aktiengesellschaft). The substance was
administered over the whole surface of a 2.5 x 2.5 em cellulose patch on a piece of
surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was
fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test
substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72
hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the
score of DRAIZE (see Appendix "Scale for scoring dermal reactions", page 11). All
other changes of the skin were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
One hour after removal of the patch the treated skin of the animals showed very slight
erythema. One day after removal of the patch the irritations were reversible.
Based on the results of this study Beta W 7 A 1.0 is not irritating to skin.
Other effects:
One hour after removal of the patch the treated skin of the animals showed very slight
erythema. One day after removal of the patch the irritations were reversible.
Based on the results of this study Beta W 7 A 1.0 is not irritating to skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.
Executive summary:

Testing of Beta W 7 A 1.0 for primary dermal irritation in the rabbit according to OECD 405 showed that the substance is not irritating to skin.