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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: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FEDERAL REGISTER 38 No. 187 § 1500.41 (SKIN) PAGE 2701, SEPT. 27, 1973
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Korantin SC 9437 (now: Korantin MAT)
- Physical state: liquid
- Analytical purity: ca. 100 % (UVCB)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: about 3 to 4 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 55 +- 10
- Air changes (per hr): completely air-conditioned, 100 % of fresh air, filtered through Class C fine filter
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved, with out without abrasion
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- % coverage: 2.5 x 2.5 cm2
- Type of wrap if used: occlusive

SCORING SYSTEM: as descibed in OECD 404 guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/72 hours
Score:
1.92
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean scores individual animals: 1 in 1/6 animals, 2 in 4/6 animals, 2.5 in 1/6 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/72 hours
Score:
2.59
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: mean scores individual animals: 2 in 4/6 animals, 3.5 in 1/6 animals, 4 in 1/6 animals

Any other information on results incl. tables

24 h after application: erythema and edema in all rabbits extend far beyond the areas of application (about 1/3 of the back).

3 d after application: erythema and edema principally in the areas of application.

Nothing abnormal was detected upon necropsy on the skin.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU