Anhydro-D-glucitol trioleate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test material

Test material information

Constituent 1

Reference substance name:

Anhydro-D-glucitol trioleate

EC Number:

247-569-3

EC Name:

Anhydro-D-glucitol trioleate

Cas Number:

26266-58-0

Molecular formula:

C60H108O8

IUPAC Name:

1,4-anhydro-2,3,6-tri-O-oleoyl-L-iditol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks
- Weight at study initiation: 2.33 and 2.86 kg
- Housing: individually in suspended cages
- Diet (ad libitum): mains drinking water
- Water (ad libitum): 2930C Teklard Global Rabbit diet
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

3 days
Reading time points: 1, 24, 48 and 72 h

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: cotton gauze patch (2.5 x 2.5 cm) which 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 wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after exposure, any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 2 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 2 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Immediately after patch removal, very slight erythema was noted at one treated skin site. The effect was fully reversible within one hour. No further effects were observed at any other time point.

Any other information on results incl. tables

Both animals showed the expected body weight gain during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified