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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study in compliance with GLP

Data source

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

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:
- Physical state: solid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2080 t o 2310 g
- Housing: individually
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Swi tzerland (ad libitum)
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Controls:
other: untreated skin of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 females
Details on study design:
An area of at least 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (20 cm2) bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80. The patches were loosely covered with aluminum foil held in place for by an adhesive tape. The animals were checked daily for systemic symptoms and mortality.

SCORING SYSTEM:
as described in OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test item induced slight erythema reactions only at the 1h timepoint.

Any other information on results incl. tables

Individual skin reaction scores:

  Animal No. 1(f) 2(f) 3(f)
Erythema 1 h 1 1 1
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
mean 24-72 h 0 0 0
Edema 1 h 0 0 0
24 h 0 0 0
48 h 0 0 0
72 h 0 0 0
mean 24-72 h 0 0 0

Individual body weights (g):

Animal No.

1 (f)

2 (f) 3 (f)
at start of test 2095 2080 2310
after 3 days (end) 2170 2110 2380

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test item is considered to be "not irritating" to rabbit skin.
Executive summary:

The primary skin irritation potential of the test substance was investigated according to OECD test guideline no. 404. The test item was applied by topical application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the patches. The test item induced slight erythema reactions when applied to albino rabbit skin. The reactions were observed only one hour after removing the

bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, the test substance can be classified as non-irritant.