Registration Dossier

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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
The test article was weighed and 0.5 g was moistened with distilled water (made pasty) to ensure
good contact with the skin.

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100 %
- Type of wrap if used: patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with destilled water
- Time after start of exposure: 4 hours


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 (injuries in depth) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

OEDEMA FORMATION
No oedema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0
Very slight oedema (barely perceptible) . . . . . . . . . . . . . . . . . . . . . . 1
Slight oedema (edges of area well defined by
definiteraising) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate oedema (raised approximately 1.0 mm) . . . . . . . . . . . . . 3
Severe oedema (raised more than 1.0 mm and
ex tending beyond area of exposure) . . . . . . . . . . . . . . . . . . . . . . . . 4

Results and discussion

Any other information on results incl. tables

Irritation parameter Basis Time point Score
erythema score animal #1 D9878/M 1 hour 1
erythema score animal #1 D9878/M 24 hours 0
erythema score animal #1 D9878/M 48 hours 0
erythema score animal #1 D9878/M 72 hours 0
edema score animal #1 D9878/M 1 hour 0
edema score animal #1 D9878/M 24 hours 0
edema score animal #1 D9878/M 48 hours 0
edema score animal #1 D9878/M 72 hours 0
erythema score animal #2 D9879/M 1 hour 1
erythema score animal #2 D9879/M 24 hours 1
erythema score animal #2 D9879/M 48 hours 0
erythema score animal #2 D9879/M 72 hours 0
edema score animal #2 D9879/M 1 hour 0
edema score animal #2 D9879/M 24 hours 0
edema score animal #2 D9879/M 48 hours 0
edema score animal #2 D9879/M 72 hours 0
erythema score animal #3 D9880/M 1 hour 1
erythema score animal #3 D9880/M 24 hours 1
erythema score animal #3 D9880/M 48 hours 0
erythema score animal #3 D9880/M 72 hours 0
edema score animal #3 D9880/M 1 hour 0
edema score animal #3 D9880/M 24 hours 0
edema score animal #3 D9880/M 48 hours 0
edema score animal #3 D9880/M 72 hours 0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test article is a mild irritant but not corrosive.
Executive summary:

Erythema, slight at 30 - 60 minutes after patch removal, was
absent to slight at 24 hours and absent at 48 and 72 hours. 
Edema, was absent at all observation intervals.  There were
no abnormal physical signs noted during the observation
period.Primary Irritation Index of 0.17 (mildly irritating)
when applied to the intact skin as a paste.