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Administrative data

Description of key information

The key study for skin sensitisation found the test material not sensitising, as concluded in a local lymph node assay in mouse. The study was compliant with current OECD guideline and conducted according to GLP (Harlan 2012).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 -26 July 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA/CaOlaHsd
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: Individually housed in suspended solid floor polypropylene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
Undiluted test item or the test item at concentrations of 50% or 25% v/v in acetone/olive oil 4:1.
No. of animals per dose:
4
Details on study design:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Groups of mice were treated with the undiluted test item or the test item at concentrations of 50% or 25% v/v in acetone/olive oil 4:1. The preliminary screening test suggested that the test item would not produce systemic toxicity or excessive local skin irritation at the highest suitable concentration. The mice were treated by daily application of 25ul of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.
Five day sfollowing the first topical application of the test item or vehicle (Day 6) all mice were injected via the tail vain with 250ul of phosphate buffered saline containin3H-methyl thymidine givin a total of 20 uCi to each mouse.
Five hours following the administration of 3HTdR all mice were killed. The draining auricular lymph nodes from four mice were excised and pooled for each experimental group. The lymph fluid wa sprocessed and the incorporation of the radiolabel measured by beta-scintillation counting, and the number of radioactive disintegrations per minute was then measured. The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node, and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).


- Criteria used to consider a positive response: The test item was regarded as a sensitiser if at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test item failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a non-sensitiser.

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Parameter:
SI
Value:
ca. 1.26
Test group / Remarks:
25% concentration
Parameter:
SI
Value:
ca. 1.47
Variability:
50% concentration
Parameter:
SI
Value:
ca. 0.79
Test group / Remarks:
100% concentration
Parameter:
other: disintegrations per minute (DPM)
Value:
12 912.09
Test group / Remarks:
Vehicle
Parameter:
other: disintegrations per minute (DPM)
Value:
16 301.07
Test group / Remarks:
25% concentration
Parameter:
other: disintegrations per minute (DPM)
Value:
19 025.12
Test group / Remarks:
50% concentration
Parameter:
other: disintegrations per minute (DPM)
Value:
10 189.81
Test group / Remarks:
100% concentration

Bodyweight changes of the test animals were comparable to those observed in the corresponding control group animals over the same period. There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was considered to be a non-sensitiser in a local lymphnode assay in mouse, conducted in accordance with current OECD guideline and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test material was considered to be a non-sensitiser in a local lymph node assay in mouse, conducted in accordance with current OECD guideline and in compliance with GLP (Harlan, 2012).

There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Bodyweight changes of the test animals were comparable to those observed in the corresponding control group animals over the same period.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information no classification is required for tetrahydrofurfuryl alcohol for sensitisation, in accordance with current EC Regulation No. 1272/2008.