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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:
May 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 h exposure instead of 4 h
Qualifier:
according to
Guideline:
other: FDA Guideline ยง1500.41 Federal register 38, No. 187, 27.09.1973, p 27019
Deviations:
no
GLP compliance:
no
Remarks:
performed before GLP guidelines

Test material

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

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG own breed
- Strain: Albino Himalayan, Hoe:HIMK(SPFWiga)
- Weight at study initiation: 1,5-2,5 kg
- Diet: ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water ad libitum


ENVIRONMENTAL CONDITIONS
- Housing: single cages

Inlife data: from 20.03. to 23.03.1979

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g of pure substance (moistened with 0.9 % NaCl solution) was applied
Duration of treatment / exposure:
24 h
Observation period:
24 hours post application
48 hours post application
72 hours post application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- % coverage: 100 %
The substance was applied over the whole surface of a 2.5 cm2 gauze patch. The patches were fixed with adhesive tape to the prepared skinarea (ca. 18 cm2) and then covered with an occlusive polyethylene foil and further fixed with an elastic bandage (Elastoplast).

SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

For each animal the rating for Erythema and eschar formation as well as for Oedema formation was added after 24 and 72 hours. The sum of all values of all animals was calculated and divided by the number of animals and the factor of 4. The classification was conducted according to following evaluation classes:

0.0-0.5..........non irritant
0.6-3.0..........slightly irritant
3.1-5.0..........moderately irritant
5.1-8.0..........severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effect
Irritant / corrosive response data:
No erythema/edema observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
With reference to the reported scores (mean score of 6 animals (erythema): 0; mean score of 6 animals (edema): 0) and the absence of effects the test item has not to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Executive summary:

The test substance is considered as not irritant under the conditions of this Patch-test.