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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study reliable without restrictions Minor deviations from the guideline withhout effect on the results: - According to the guideline, approx. 24 h before the test the fur should be removed by clipping or shaving. In this study it was only stated that the fur was clipped at least 15 h before the beginning of the test. - According to the guideline, the examination for erythema and oedema should take place at 30 - 60 minutes, and then at 24, 48, 72 h after patch removal. In this study the examination took place at 30 -60 minutes after removal of the test patches and 24 h, 48 h, 72 h after the beginning of application. - A modified Draize scoring system was used. - The readings of skin reaction at 30 - 60 minutes were missing in the test report. Instead a reading at 4 hours was mentioned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, adopted 1981-05-12
Deviations:
yes
Remarks:
see "rational for reliability"
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: Powder, yellow
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach/Main, FRG
- Average weight at study initiation: Female rabbit: 2.45 kg; male rabbit: 3.08 kg; male rabbit: 3.23 kg
- Housing: Individual housing of rabbits; Cage made of stainless steel with wire mesh walk floors; Floor area: 40 cm X 51 cm; No bedding in the cages; Sawdust in the waste trays
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG; CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test patch (2.5 cm X 2.5 cm) was covered with a dose of 0.5 g of the unchanged test substance and has been moistened with aqua. bidest.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (Readings at 30 -60 minutes after removal of the test patches and 24 hours, 48 hours, 72 hours after the beginning of application)
Number of animals:
1 male /2 females
Details on study design:
TEST SITE
- Area of exposure: Application area was 2.5 cm X 2.5 cm. The application site was the upper third of the back or flanks. The untreated skin sites of the animals served as negative control.
- Type of wrap if used: Test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: At the end of the exposure period

SCORING SYSTEM: A modified Draize scoring system was used.
Evaluation of erythema and oedema:
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe
No further information on the study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: The 24, 48 and 72 hours reading times were taken 24, 48 and 72 hours after the beginning of application.
Irritant / corrosive response data:
At the 24 hour reading very slight erythema was observed in the two male rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.