D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 December 2013 to 21 December 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Adequate in vivo testing carried out for US regulation, hence no in vitro study is provided.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

EC Number:

941-129-0

Cas Number:

1407974-32-6

Molecular formula:

C15H28O7 - C25H46O7

IUPAC Name:

D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

Test material form:

liquid: viscous

Details on test material:

- Substance type: UVCB
- Physical state: viscous yellowish liquid
- Analytical purity: 100% as UVCB
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd. Hillcrest, Dodgeford Lane Belton, Loughborough Leics, LE12 9TE / UK
- Age at study initiation: 11 weeks
- Weight at study initiation: 1791 - 1967g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C (batch no. 11/13 provided by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum.
- Water (e.g. ad libitum): Community tap-water from Itingen ad libitumin water bottles.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 ± 3 °C
- Humidity (%):30 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours darkness.

IN-LIFE DATES: From: 10 December 2013 To: 21 December 2013

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/animal

Duration of treatment / exposure:

4 Hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 100 cm2
- Type of wrap if used:adhesive hypoallergenic aerated semi-occlusive dressing and a restrainer bandage wrapped around the trunk

SCORING SYSTEM:The skin reaction was assessed according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean erythema/eschar and oedema score for each of the three animals was therefore 0.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is considered to be “not irritating” to rabbit skin.

Executive summary:

Introduction

The acute dermal irritation potential of the test item was investigated according to OECD test guideline No. 404, Commission Regulation (EC) No. 440/2008, B.4, Japanese MAFF 12-Nousan.8187 (2000) and EPA OPPTS 870.2400 (1998).

Method

The test item was applied by topical semi-occlusive application of 0.5 mL to the intact skin of the left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated separately for each animal across 3 scoring times (24, 48 and 72 hours after patch removal) for erythema/eschar grades and for oedema grades, respectively.

Results

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean erythema/eschar and oedema score for each of the three animals was therefore 0. The test item did not cause any staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin. The test item is considered to be “not irritating” to rabbit skin.