Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

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:
- Name of test material (as cited in study report): 625-Triketone
- Substance No.: 95/225-1
- Physical state: Powder, beige
- Analytical purity: 99.4 %
- Lot/batch No.: LJ 27881/1
- Date of manufacturing: 18-27 Jul 1995
- Stability under test conditions: verified by reanalysis
- Storage condition of test material: refrigerator

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Strain/Quality: WHITE NEW ZEALAND (SPF)
- Age at study initiation: young adult animals
- Weight at study initiation: animals of comparable weight; 3.53-4.0 kg
- Fasting period before study: none
- Housing: single housing
- Diet: KLIBA-Labordiaet 341, Klingenthalmuehle AG Kaiseraugst, Switzerland, about 130 g per day
- Water: tap water about 250 ml per day
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Analysis of drinking water
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the technical services of the BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in the study was assayed for chemical and microbial contaminates.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- The unchanged solid material has been moistened with aqua bidest. (because of the natural moisture of the skin distilled water was used, so the test has been carried out under as physiological conditions as possible)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (since the animals did not show any skin reactions to the treatment up to 72 hours after removal of the patch the study was terminated. Therefore, the reduced observation period does not represent a deviation from the protocol recommended by the guidance documents.)
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks (2.5 cm x 2.5 cm)
- Type of wrap if used: dressing consisting of the test patch (“Idealbinde”, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and “Fixomull (R) Stretch” (adhesive fleece), Beiersdorf AG.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol concentrated and Lutrol diluted with water to 50 %

SCORING SYSTEM:
The OECD Draize scoring system has been used to assess the skin findings

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Other effects:
No other signs of toxicity occurred.

Applicant's summary and conclusion