Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.7 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionell breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 1.9 - 2.6 kg
- Housing: single cages located in completely air conditioned rooms
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, Altromin-GmbH, Lage/Lippe, ad libitum plus 15 g hay per day
- Water. deinized and chlorinated water from automatic dispensors, ad libitum)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+- 20
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg test substance suspended with 0.4 ml 0.9% NaCl-solution
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100
- Type of wrap if used: semiocclusive bind

REMOVAL OF TEST SUBSTANCE
- Washing: slighly warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30 - 60 min after removal of the plaster
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30 - 60 min after removal of the plaster
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this test the substance is considered as not irritating to the skin.
Executive summary:

The substance was tested for skin irritation according to OECD Guideline 404. 500 mg of the substance were suspended with physiologic saline solution. This suspension were administered to the abraded skin of 3 rabbits and fixed with a semiocclusive bind.

After 4 hours the substance was removed by washing and the edema and erythem scores were determined. Both scores were 0.