Registration Dossier

Diss Factsheets

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: According to guideline study (OECD 404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
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): Isododecene

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, FRG
- Age at study initiation:
- Weight at study initiation: Animal 1 (female) - 2.97 kg ; Animal 2 (male) - 3.31 kg ; Animal 3 (male) - 3.02 kg
- Housing: 1 animal per cage; in cages made of stainless steel with wire mesh walk floors (without bedding)
- Diet (e.g. ad libitum): about 130 g per animal per day (KLIBA 341)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days (same housing conditions as during the study)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
There were no deviations from these ranges which influenced the results of the study.

Animal identification: Ear tattoo

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 ml
- Concentration (if solution): undiluted


Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: four layers of absorbent gauze + porous bandage
Clipping of the fur: at least 15 hours before the beginning of the study. Test substance was applied on the test patch which was then applied to the skin.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period


SCORING SYSTEM: Draize score
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, 72 h, 8 d and 15 d after the beginning of application
(For calculation of the means of erythema and edema only the readings of 24, 48 and 72 hours are used)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 72 hours
Score:
2.7
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 72 hours
Score:
3
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 72 hours
Score:
3.3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
3
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 72 hours
Score:
2.3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 72 hours
Score:
3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 - 72 hours
Score:
0.7
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
2

Any other information on results incl. tables

   Animal No.  Erythema  Edema
 Day 8  1  1  1
   2  2  1
   3  2  0
 Day 15  1  0  0
   2  0  0
   3  0  0

Irritation signs were fully reversible.

Applicant's summary and conclusion