D-Glucitol, 1,3:2,4-bis-O-[(4-chlorophenyl)methylene]-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-08 - 2012-05-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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 (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

EC Number:

700-591-1

Cas Number:

82203-23-4

Molecular formula:

C20H20Cl2O6

IUPAC Name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Expiration date of the lot/batch: December 2012
- Storage condition of test material: At room temperature, protected from moisture

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 - 11 weeks (1st pre-test); 11 - 12 weeks (2nd pre-test); 8 - 9 weeks (main study)
- Weight at study initiation: 21.3 - 23.2 g (1st pre-test); 21.2 - 22.5 g (2nd pre-test); 17.2 - 21.2 (main study)
- Housing: group
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2 °C
- Humidity (%): 33 – 65 % (acclimation period); 45 – 65 % (pre-test and main study)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (LLNA)

Vehicle:

dimethyl sulphoxide

Concentration:

0.5, 1 and 2.5 % (w/v) in the main study

No. of animals per dose:

4 (pre-test), 16 (main study)

Positive control substance(s):

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

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

1

Test group / Remarks:

test concentration: 0 %

Results 2

Parameter:

SI

Value:

1.23

Test group / Remarks:

test concentration: 0.5 %

Results 3

Parameter:

SI

Value:

0.77

Test group / Remarks:

test concentration: 1%

Results 4

Parameter:

SI

Value:

1.07

Test group / Remarks:

test concentration: 2.5%

Results 5

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 1. 0 %: 191.4 (DPM per lymph node) 2. 0.5 %: 235.6 (DPM per lymph node) 3. 1 %: 147.6 (DPM per lymph node) 4. 2.5 %: 204.1 (DPM per lymph node)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

All treated animals survived the scheduled study period. In this study stimulation indices of 1.23, 0.77, and 1.07 were determined with the test item (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol at concentrations of 0.5, 1, and 2.5 % (w/v) in DMSO. A clear dose response was not observed. The EC3 value could not be calculated, because none of the tested concentrations induced a S.I. greater than the threshold value of 3. The test item was not a skin sensitiser under the test conditions of this study.