Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990 - 1991
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:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 98.2%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionial breeding
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 3.5 - 4.5 kg
- Housing: in air conditioned rooms in single cages
- Diet: Altromin 2123 - rabbit ( ad libitum) and 15 g hay per day
- Water: deionized and chlorinated water from automatic suspensors ( ad libitum)
- Acclimation period:

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:
clipped
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg suspended in 0.4 ml 0.9% NaCl-solution
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100%
- Type of wrap if used:plaster fixed with a semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with slightly 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: 60 min
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 min
Score:
0
Max. score:
4
Irritant / corrosive response data:
no signs for irritation occured

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not skin irritating
Executive summary:

The substance was tested for skin irritation according to OECD 404. 3 male New Zealand White rabbits got applicated 500 mg of the test substance suspended in 0.4 ml 0.9% NaCl-solution.The exposure time was 4 hours. After removing the plaster and washing the contaminated skin no sign for skin irritation could be observed