.beta.-D-Ribofuranose, 5-deoxy-, 1,2,3-triacetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 July 2012 to 20 June 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Fully GLP compliant and in accordance with current test guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Acetylfuranoside

IUPAC Name:

Acetylfuranoside

Constituent 2

Reference substance name:

ß-D-Ribofuranose, 5-deoxy-, triacetate (6CI,9CI)

EC Number:

612-957-7

Cas Number:

62211-93-2

Molecular formula:

C11 H16 O7

IUPAC Name:

ß-D-Ribofuranose, 5-deoxy-, triacetate (6CI,9CI)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: Acetylfuranoside (also known as ß-D-Ribofuranose, 5-deoxy-, 1,2,3-triacetate)
CAS number: 62211-93-2
Batch number: 201203272009
Quantity received: 1.2 kg
Purity: 98.7%
Retest date: 31 Mar 2013
Date of receipt: 14 September 2012
Storage details: When not in use the test item was stored in a sealed container, at room temperature, in the dark.

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/CaCrl

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Age at study initiation: 9 to 10 weeks old
- Weight at study initiation: 18 to 21 g
- Housing: The animals were group housed during acclimatisation and individually housed from Day –1 in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, expanded, from Special Diets Services Ltd, Witham, UK was freely available to the animals at all times.
- Water (e.g. ad libitum): Mains water was provided, ad libitum, via cage-mounted water bottles.
- Acclimation period: 8 to 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): The animal rooms were designed to permit 15 to 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by fluorescent strip-lights for twelve hours daily.

IN-LIFE DATES: From: 23 October 2012 To: 06 November 2012

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

Low concentration: 10% w/v
Intermediate concentration: 25% w/v
High concentration: 50% w/v

No. of animals per dose:

4 animals per dose

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

mercaptobenzothiazole (CAS No 149-30-4)

Statistics:

Not applicable

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1.1

Test group / Remarks:

10%

Remarks on result:

other: see Remark

Remarks:

Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0. Low concentration: 1.1 SI Intermediate concentration: 1.0 SI High concentration: 1.1 SI

Results 2

Parameter:

SI

Value:

1

Test group / Remarks:

25%

Results 3

Parameter:

SI

Value:

1.1

Test group / Remarks:

50%

Results 4

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Vehicle control: 1598 DPM Low concentration: 1807 DPM Intermediate concentration: 1591 DPM High concentration: 1814 DPM

Any other information on results incl. tables

Mortality

All animals survived treatment.

Clinical signs

There were no clinical signs indicative of a systematic effect.

The vehicle and test formulation application sites remained free of irritation.

Body weights

There was no idication of a treatment related effect on body weight.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The Local Lymph Node Assay demonstrated that Acetylfuranoside does not have the potential to cause skin sensitisation.
The test item did not meet the criteria for classification as a sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Executive summary:

This study was conducted to assess the potential of the test item, Acetylfuranoside, to cause skin sensitisation in the mouse.

Following a preliminary screening test using a 50% w/v formulation, the test item was prepared for administration at 10, 25 and 50% w/v in dimethylformamide. Groups of four female CBA / CaCrl mice were subjected to topical applications of vehicle or of one of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 µCi dose of tritiated ³H-methyl thymidine was injected intravenously into each mouse. Approximately five hours later, the auricular lymph nodes were recovered from each animal. The nodes from mice subjected to the same treatment were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.

Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.

	Concentration of test item in applied formulation (% w/v)
	10%	25%	50%
Stimulation Index	1.1	1.0	1.1

The Local Lymph Node Assay demonstrated that Acetylfuranoside does not have the potential to cause skin sensitisation.

The test item did not meet the criteria for classification as a sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).