1,4:3,6-dianhydro-D-glucitol

Skin irritation / corrosion

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: French Norm from AFNOR for chemicals : NF T 03-263

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,4:3,6-dianhydro-D-glucitol

EC Number:

211-492-3

EC Name:

1,4:3,6-dianhydro-D-glucitol

Cas Number:

652-67-5

Molecular formula:

C6H10O4

IUPAC Name:

1,4:3,6-dianhydro-D-glucitol

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 or test system 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.