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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 without GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): D-Pantolacton kristallin
- Physical state: solid white crystals
- Analytical purity: >99 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: mean weight males 2.95 kg; female 3.23 kg
- Housing: in cages made of stainless steel with wire mesh walk floors; floor area 40 cm x 51 cm
- Diet: Kliba 341, 4 mm (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control.
Amount / concentration applied:
ca. 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 animals; 2 males and 1 female
Details on study design:
- Application area: 2.5 cm x 2.5 cm
- Application volume: The test patch (2.5 cm x 2.5 cm) was covered with a dose of 0.5 g of the unchanged test material and has been moistened with aqua dest; because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible. The test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage).
After an application time of 4 h, the treated skin sites were washed with lutrol and water/lutrol.
- Application site: upper third of the back or flanks
- Readings: 30-60 min after removal of the test patches and 24h, 48h, and 72 h after the beginning of application


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, AT THE END OF THE EXPOSURE PERIOD WITH LUTROL AND LUTROL/WATER (1:1)
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
At reading time point 4 h, no edema was seen for all animals; erythema scores were 2, 2 and 1, respectively for the 3 individual animals. No signs of irritation were noted at reading time points 24-48-72 h for all animals.

Applicant's summary and conclusion