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:
1999-07-06 to 1999-07-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
January 1997
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Mol:Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre AIS, Ejby, DK-4623 Lilie Skensved
- Housing: animal room
- Diet: Rabbit diet "Altromin 2123" (supplier: Altromin, D-32791 Lage, Lippe, Germany) was available ad libitum.
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: ca. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 °C
- Humidity: 55 % ± 15 %
- Air changes: 10 times/hour
- Photoperiod: 12 hours light and 12 hours darkness

IN-LIFE DATES: From: 1999-07-06 To:1999-07-28

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL of the test article

Duration of treatment / exposure:
4 h
Observation period:
21 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 2.5 cm wide adhesive Gothaplast tape and fixed with Gothaplast tape, 5 cm width, loosely wound round the trunk

REMOVAL OF TEST SUBSTANCE
- Washing: mild soap and lukewarm water
- Time after start of exposure: 1, 24, 48, 72


SCORING SYSTEM:
According to the directive ofthe EEC commission 93/21/EEC of May 4, 1993

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean individual score
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: mean individual score
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: mean individual score
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: mean individual score
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no skin irritation visible
Remarks on result:
other: mean individual score
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: mean individual score
Irritant / corrosive response data:
Very slight skin reactions were observed among the rabbits. These reactions were not complete reversible in one animal 21 days after application of the test article. Based on the experimental data the test item has not be classified as skin irritating.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU