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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study but with restrictions (no data on test substance purity and no GLP) .

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
yes
Remarks:
(no data on test substance purity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002
Deviations:
yes
Remarks:
no weight-of-evidence analysis for performing an in vivo study, no data on test substance purity, no justification for choice of vehicle
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

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: 2.2 - 2.3 kg
- Housing: individually in metal cages, identified with individually numbered ear tags
- Diet (ad libitum): standard rabbit pellet (Nafag No. 814, Gossau, Switzerland)
- Water (ad libitum): fresh
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant 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 (prepared by Pharmaceuticals Division, CIBA-Geigy Ltd.)
Controls:
other: untreated contralateral flank of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3 male animals
Details on study design:
TEST SITE
- Area of exposure: 6 cm² of the flank
- Type of wrap if used: Gauze patch moistened with the vehicle ( and the test substance on the treatment flank). It was loosely covered with aluminium foil (36 cm²), held in place by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
mean out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
mean out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
One hour after exposure 2 out of 3 animals developed erythema grade 1, one animal erythema grade 2.
One hour after exposure one animal out of 3 developed edema grade 1, one animal edema grade 2.
Other effects:
Body weight gains were as expected.

Any other information on results incl. tables

Tab. 1: Individual Skin reaction score after treatment with the test substance

(CF = control flank, TF = test flank, M = male)

animal no.

erythema

edema

7 /M

8 /M

9 /M

7 /M

8 /M

9 /M

CF/TF

CF/TF

CF/TF

CF/TF

CF/TF

CF/TF

after 1 hr.

0/1

0/1

0/2

0/0

0/1

0/2

after 24 hrs.

0/0

0/1

0/1

0/0

0/0

0/0

after 48 hrs.

0/0

0/0

0/0

0/0

0/0

0/0

after 72 hrs.

0/0

0/0

0/0

0/0

0/0

0/0

mean 24-72 hrs.

0/0

0/0.33

0/0.33

0/0

0/0

0/0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information