Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with regulatory guidelines OECD429 and EU B.42 and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
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

Constituent 1
Chemical structure
Reference substance name:
Decane-1,2-diol
EC Number:
214-288-2
EC Name:
Decane-1,2-diol
Cas Number:
1119-86-4
Molecular formula:
C10H22O2
IUPAC Name:
decane-1,2-diol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Decan-1,2-diol
- CAS number: 1119-86-4
- EC number: 214-288-2

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Test animals: CBA/CaOlaHsd mice
- Source: Harlan NetherlandsB.V. Postbus 6174
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 16-24g
- Housing: Single Makrolon type-2 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light- 12 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: acetone : olive oil (AOO) 4:1 (v/v)
Concentration / amount:
5, 10, 25 and 50%
Challengeopen allclose all
Route:
other: none
Vehicle:
other: acetone : olive oil (AOO) 4:1 (v/v)
Concentration / amount:
5, 10, 25 and 50%
No. of animals per dose:
Four
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Once daily for three consecutive days
- Exposure period: 24 hours for each of the three days
- Test groups: 4
- Control group: 1
- Site: dorsal surface of both ear lobes
- Frequency of applications: once daily
- Duration: 3 days
- Concentrations: 5, 10, 25 and 50%
- Administraton of 3H-methyl thymidine: Five days after the first topical application, all mice were administered with 250 µl of 83.1 µCi/ml 3HTdR by intravenous injection via a tail vein.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
5, 10, 25 and 50%
No. of animals per dose:
Four
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: Not reported
- Irritation: Not reported
- Lymph node proliferation response: Not reported

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay
- Criteria used to consider a positive response: Stimulation Index >3

TREATMENT PREPARATION AND ADMINISTRATION:
Topical (epidermal) application to dorsal surface of each ear lobe. A volume of 25 uL was spread over the entire dorsal surface (0-8mm) once daily for 3 consecutive days.

Five days after the first topical application, all mice were administered with 250uL of 83.1uCi/mL 3H methyl thymidine by intravenous injection into the tail vein. Five hours later animals were killed and draining lymph nodes excised and pooled for each experimental group i.e. 8 per group apart from group 3 (10%) where only 7 nodes were extracted.
Statistics:
Mean value and standard deviations for bodyweights only.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Control - 1 5% -2.4 10% -2.7 25% - 1.6 50% - 2.2 Calculation of the EC3 value was not possible as an SI of 3 or higher was not reached in the study.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Control - 1381 (pooled); 173 per lymph node 5% - 3334 (pooled); 417 per lymph node 10% - 3304 (pooled); 471 per lymph node (only 7 lymph nodes collected) 25% - 2207 (pooled); 275 per lymph node 50% - 3099 (pooled); 387 per lymph node

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU CLP
Conclusions:
Not sensitising. No signs of local toxicity at the application site was noted.
Executive summary:

Four groups each of four female mice were treated daily with the test item at a concentration of 5, 10, 25 or 50% (w/v) in acetone : olive oil 4:1 (w/v) by topical application to the dorsal surface of each ear lobe for three consecutive days. A control group of four mice was treated with the vehicle. Five days after the first topical application, the mice were injected intravenously with radio-labelled thymidine. Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by incorporation of 3H methyl thymidine measured in a beta scintillation counter.

Disintegrations per minute were determined per lymph node sample and Stimulation Indices (SI) relative to control group were calculated as follows:

5% SI= 2.4

10% SI = 2.7

25% SI = 1.6

50% SI= 2.2

Calculation of the EC3 value was not possible as a SI of 3 or higher was not reached in the study.

Decan-1,2-diol at concentrations up to 50% was found not to be a skin sensitiser.