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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:
1986-02-18 to 1986-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP and guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP compliance statement attached to full study report.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: Hoechst AG, Kastengrund, conventional breed
- Identification: numbered earmarks
- Weight: 2.6 - 3.2 kg
- Age: approx. 3 - 5 months
- Housing: single cages in air conditioned rooms
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hours daily
- Diet: Altromin 2123, ad libitum, hay: approx 15g daily
- Water: deionised, chlorinated water from automatic dispensers, ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethylene glycol 400
Controls:
no
Amount / concentration applied:
- 500 mg of test substance mixed with 0.3 ml of the vehicle.
Duration of treatment / exposure:
4 hrs
Observation period:
30-60 mins, 24, 48, 72 hrs
Number of animals:
3
Details on study design:
- Area of exposure: 2.5 x 2.5 cm
- Cellulose pad
- Washing with luke warm tap water after 4 hrs of exposure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
30-60 mins after removal of the patch one animal showed a clearly distinct erythema. 24 hrs after exposure the same animal only had a barely visible erythema. 48 hrs p.a. none of the animals showed any sign of skin irritation.

Applicant's summary and conclusion

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