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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:
August 18, 1992 - August 25, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
Short-term Toxicology CIBA-GEIGY Limited

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid; white
- 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: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2480 to 2510 g
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814
- Water: ad libitum
- Acclimation period: at least 5 days

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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
Controls:
other: untreated flank
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours, 7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: right flank
- Type of wrap if used: The patches were loosely covered with an aluminium foil (approx. 36 square cm ) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The test item caused minimal to slight erythem and edem visible in all animals 1h after removal of the patches. All effects were reversible withing 72 hours the latest.

Any other information on results incl. tables

Individual skin reaction scores:

reading animal Erythema Edema
1h 1 2 1
2 2 1
3 2 1
24h 1 2 1
2 1 0
3 1 0
48h 1 1 0
2 0 0
3 0 0
72h 1 0 0
2 0 0
3 0 0
7 d 1 0 0
2 0 0
3 0 0
mean 24-72h 1 1 0.33
2 0.33 0
3 0.33 0
mean 24-72h 0.6 0.1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions employed the test item induced erythema and edema reactions below the threshold of significance. Therefore, the test item can be classified as non-irritant.