Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-05-21 to 2007-06-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: white albino; strain: Chbb:HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH; Stolzenseeweg 32-36; D-88353 Kißlegg, Germany
- Age at study initiation: 9 to 27 months
- Weight at study initiation: 2.7 - 2.9 kg
- Housing: individually in PPO cages (floor area 2576 sq.cm) with perforated floor
- Diet: pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe; Germany, ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 from 6 am to 6 pm

IN-LIFE DATES: From: 2007-05-21 To: 2007-06-02

Test system

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

VEHICLE: None
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: semi-occlusive adhesive (Gothaplast, 2.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing: yes; with mild soap and lukewarm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the guidelines stated in Directive 2001/59/EEC of August 6th, 2001

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(3251)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(3865)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(3724)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(3251)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(3865)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(3724)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance has no potential for skin iritation in this test.
Executive summary:

The test item was investigated for its skin irritation potential in accordance with OECD guideline 404 under GLP compliance. No irritation was observed in any animal. The test substance has no potential for skin iritation in this test.