Registration Dossier

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: Non-GLP study, deviations to current testing protocols

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Guideline:
other: FED. REG. 38, NO. 187, SECTION 1500.41 P. 27019, SEPT. 27, 1973
Deviations:
no
Principles of method if other than guideline:
Method: other: according to Fed. Reg. 38, No. 187, section 1500.41, p. 27019, Sept. 27, 1973
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lusantan MCE
- Physical state: oily liquid
- Analytical purity: approx. 100%
- Lot/batch No.: 84/127
- Expiration date of the lot/batch: > 2 years



Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, Germany
- Weight at study initiation: 2,45; 2.46; 2.89; 2;88; 3.21; 2;98 (kg)
- Housing: CAGE MADE OF STAJNLESS STEEL WITH WIRE MESH WALK FLOORS, FLOOR AREA: 40 CM X 51 CM, NO. OF ANIMALS PER CAGE: 1; NO BEDDING IN THE CAGES; SAWDUST IN THE WASTE TRAYS
- Diet (e.g. ad libitum): ABOUT 130 G PER ANIMAL PER DAY
- Water (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Acclimation period: AT LEAST 8 DAYS BEFORE THE BEGINNING OF THE STUDY: SAME HOUSING CONDITIONS AS DURING THE STUDY


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 H/12 H (6.00 - 18.00 HOURS/18.00 - 6.00 HOURS)

IN-LIFE DATES: From: 28.01.1985 To:12.02.1985

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipping of fur
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ML of test substance on a 2.5 CM X 2.5 CM patch
Duration of treatment / exposure:
24 hour(s)
Observation period:
30 -60 MIN, 24H, 48H, 72H, 8D, 15D
Number of animals:
6 (5 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 CM X 2.5 CM


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
EVALUATION OF ERYTHEMA AND EDEMA:
0 = NONE
1 = YERY SLIGHT
2 = WELL-DEFINED
3 = MODERATE TO SEVERE
4 = SEVERE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Scaling observed in 1/6 animals
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1-6
Time point:
other: 24, 48, 72 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Scaling observed in 1/6 animals

Any other information on results incl. tables

Readings Animal Erythema Edema Further findings
24h 1 2 1  
  2 2 0  
  3 2 1  
  4 2 1 R:E
  5 2 0  
  6 2 1  
48h 1 1 0  
  2 1 0  
  3 2 0  
  4 2 0 R:E
  5 1 0  
  6 2 0  
72h 1 1 0  
  2 1 0  
  3 2 0  
  4 2 0 R:E
  5 1 0  
  6 2 0  
8d 1 0 0  
  2 0 0  
  3 0 0  
  4 1 0 S
  5 1 0  
  6 0 0  
15d 1 0 0  
  2 0 0  
  3 0 0  
  4 0 0  
  5 0 0  
  6 0 0  
Mean (24h-72h) 1 1,3 0,3  
  2 1,3 0,0  
  3 2,0 0,3  
  4 2,0 0,3  
  5 1,3 0,0  
  6 2,0 0,3  
Mean (24h-72h) all animals 1,7 0,2  
R:E = Erythema, extending beyond the area of exposure S = Scaling. Similar findings after application on abraded skin with mean (24h-72h) erythema/edema score (all animals): 1,7/0,3 (not relevant for assessment). Findings 30 -60 min after pach removal were not reported.

Applicant's summary and conclusion