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Toxicological information

Skin sensitisation

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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)

Resultsopen allclose all
Parameter:
SI
Value:
1
Test group / Remarks:
test concentration: 0 %
Parameter:
SI
Value:
1.23
Test group / Remarks:
test concentration: 0.5 %
Parameter:
SI
Value:
0.77
Test group / Remarks:
test concentration: 1%
Parameter:
SI
Value:
1.07
Test group / Remarks:
test concentration: 2.5%
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.