Constitutional isomers of penta-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hexa-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hepta-O-allyl-β-D-fructofuransoylα-D-glucopyranoside

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 May 2014 to 10 May 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: There were no deviations (unplanned changes) from the study plan.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

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:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Constitutional isomers of penta-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hexa-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hepta-O-allyl-β-D-fructofuransoylα-D-glucopyranoside

EC Number:

419-640-0

EC Name:

Constitutional isomers of penta-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hexa-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hepta-O-allyl-β-D-fructofuransoylα-D-glucopyranoside

Cas Number:

68784-14-5

Molecular formula:

C3H4O to C36H54O11

IUPAC Name:

2-{[3,4-bis(prop-2-en-1-yloxy)-2,5-bis[(prop-2-en-1-yloxy)methyl]oxolan-2-yl]oxy}-3,4,5-tris(prop-2-en-1-yloxy)-6-[(prop-2-en-1-yloxy)methyl]oxane

Test material form:

other: liquid

Details on test material:

Purity: 100%
Physical state / Appearance: straw colored viscous liquid
Expiry date: 04 April 2016
Storage Conditions: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

At the start of the study the animals weighed 2.32 or 2.90 kg and were twelve to twenty weeks old.
Acclimatation period of at least 5 days.
The animals individually housed.
Free access to water and food.
Temperature between 17 and 23°C
Humidity between 30 and 70%
The relative air exchange was at least fifteen changes per hour and the lighting was controlled to give 12 hours continuous light (06.00 to 18.00) and twelve hours darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of the test item

Duration of treatment / exposure:

Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.

Observation period:

Immediately following removal of patches and approximatively 1, 24, 48 and 72 hours later examination for evidence of primary irritation and scored according to the Draize scoring.

Number of animals:

2 males

Details on study design:

On the back of the rabbit. Product directly applied to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches the trunk of each rabbit was strapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No evidence of Skin irritation was noted during the study. During all the observations (directly after application, after 1 hour-exposure, 24, 48 and 72 hours-exposure), the scores for erythema/eschar/ Edema formation were 0.0

Other effects:

The body weight of the animal #74248 increased from 2.9 to 2.95 kg at day 3.
The body weight of the animal #74249 increased from 2.32 to 2.41 kg at day 3.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produce a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

Results

A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced no evidence of skin irritation. Conclusion

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.