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

Endpoint summary

Description of key information

Skin - 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. 
Eye - The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.44 for conjuctivae redness and 1 for conjunctivae chemosis.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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.

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.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 June 2014 to 23 June 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Due to technician error the initial pain reaction was not recorded for the third animal. This deviation was considered not to affect the purpose or integrity of the study.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Start of the study the animals Weighed 3.12 to 3.51 kg and were twelve to twenty weeks old.
Acclimatization period of at least five days.
Individually housed in suspended cages.
Free access to mains drinking water and food.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively.
THe rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye serves as control

Amount / concentration applied:

0.1 mL of test item

Duration of treatment / exposure:

No rinse.

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
An additional observation was made on Day 7 to assess the reversibility of the ocular effects.

Number of animals or in vitro replicates:

3

Details on study design:

Only animals free of ocular damage were used.
The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

1.44

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

No corneal effects were noted during the study.
Iridial inflammat i on was noted in one treated eye 1 hour after treatment. Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment. Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation noted in one treated eye at the 24-Hour observation. Minimal conjunctival irritation was noted in all treated eyes at the 48 and 72-Hour observations.
All treated eyes appeared normal at the 7-Day observation.

Other effects:

One animal showed body weight loss and two animals showed expected gain in body weight during the study.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.44 for cunjuctivae redness and 1.00 for cunjunctivae chemosis.

Executive summary:

Introduction

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

Results

A single application of the test item to the non-irrigated eye of three rabbits produced an isolated incident of iridial inflammation and moderate conjunctival irritation. All treated eyes appeared normal at the 7-Day observation.

Conclusion

The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.44 for conjuctivae redness and 1 for conjunctivae chemosis.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute Skin Irritation Study

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

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

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.

Acute Eye Irritation

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

A single application of the test item to the non-irrigated eye of three rabbits produced an isolated incident of iridial inflammation and moderate conjunctival irritation. All treated eyes appeared normal at the 7-Day observation.

The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.44 for conjuctivae redness and 1 for conjunctivae chemosis.