Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from July 17, 2001 to July 20,2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: In compliance with GLP and OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: French Norm from AFNOR for chemicals : NF T 03-263
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name : LAB 3085 (Isosorbide)
Order number : E0106
Reference : lot E1011
Supplier : ROQUETTE - Research Dpt
Conditioning : hermetic plastic bag
Used quantity : 6.6g
Date of reception : 13.02.01
Presentation : White cristals

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Supplier : Centre d'élevage et de sélection BARROIS - 59152 TRESSIN - France
Number/sex : 6 males
Weight : 1.8 to 2.0 kg
Age : 50 to 60 days when arrived at the laboratory
Identification: sign with a felt-tip into the right ear

Housing : stainless steel grid cages
Feed : A04C 112 - UAR - 91360 VILLEMOISSON/ORGE - France - stainless steel feeding tray - daily dose: 130g
Drinking : potable water - given ad libitum
Environment : Temperature : 21 +/-2°C - Relative humidity : 50+/-10% - Light/dark cycle : 12h/d - air renewable : 12h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 g of the item is applied to the skin on a area of 4 cm2.
Duration of treatment / exposure:
23h
Observation period:
1h, 24h and 48h after the removal of the dressing.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 4 cm2

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: 1-6
Time point:
other: Dressings removed 23h after the deposit of the substance. Observation at 1h, 24h and 45h after removing dressings.
Score:
< 5
Irritant / corrosive response data:
The cutaneous primary irritation index (IPL) is 0.5

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
LAB 3085 (Isosorbide) appears as non skin irritant in the experimental conditions of this study : 0.5g directly on a skin area of about 4 cm2, during 23 h and an observation during 45 h after the removal of the dressing.
Executive summary:

Locale tolerance study on New-Zealand rabbit, skin irritation

Number study: 01231

Assay item: LAB 3085

Guideline: OECD 404 and French norm AFNOR : NF T 03 -263

Results: After application of the item on the skin, no skin irritation was observed.

Conclusion: LAB 3085 is classified as not irritant for the skin, on the basis of the experimental study : 0.5 g of item on its own, on a skin area of 4cm2, during 23 hours and an observation during 48 hours after the removal of the dressing.