Fast Pyrolysis Bio-oil

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

01.01.2003-30.06.2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Guideline study, final study report not available. Results published in BIOTOX project (BIOTOX. 2005. An assessment of bio-oil toxicity for safe handling and transportation. Final Technical Report. Part I: Publishable Final Report. Report drafted by Blin, J. Project N°: S07.16365. Project co-ordinator: Centre de Coopération Internationale de Recherche Agronomique pour le Développement (Cirad). Partners: Aston University, Bundesforschungsanstalt für Forst- und Holzwirtschaft (BFH)).

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EC Directive No. 2004/73/EC B.42

Deviations:

not specified

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

Fast Pyrolysis Bio-oil (BIOTOX-21)

IUPAC Name:

Fast Pyrolysis Bio-oil (BIOTOX-21)

Test material form:

liquid: viscous

Details on test material:

BIOTOX-21: Biomass: Spruce, produced with Fluidised bed at 500 °C

In vivo test system

Test animals

Species:

mouse

Strain:

other: CBA/J

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

0.5, 1, 2.5, 5 or 10 %

No. of animals per dose:

4

Details on study design:

During the induction phase, bio-oil, vehicle or reference item was applied over the ears (25 μL per ear) for 3 consecutive days (days 1, 2 and 3). After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 46 tritiated methyl thymidine (day 6). The obtained values were used to calculate stimulation indices (SI).The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.

Positive control substance(s):

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

Results and discussion

In vivo (LLNA)

Results

Key result

Parameter:

EC3

Value:

ca. 3.2

Any other information on results incl. tables

Results of the "Evaluation of skin sensitization potential Mice Using LLNA" test

Treatment	Concentration (%)	Signs of local irritation	Stimulation Index (SI)
Test item	0.5	no	1.19
Test item	1	no	2.48
Test item	2.5	no	1.73
Test item	5	no	6.35
Test item	10	no	14.58
HCA	25	-	3.99

Applicant's summary and conclusion

Interpretation of results:

other: moderate sensitizer

Remarks:

Criteria used for interpretation of results: other: Kimber I. et al 2003

Conclusions:

The test item should be considered as a moderate sensitizer.

Executive summary:

The potential of fast pyrolysis bio-oil to induce delayed contact hypersensitivity was assessed in a guideline study using murine Local Lymph Node Assay (LLNA). No mortality and no clinical signs were observed during the study. No cutaneous reactions and no noteworthy increase of ear thickness were observed in the animals of the treated groups. A significant lymphoproliferation (SI > 3) was noted at the tested concentrations of 5 and 10 % .

According to study results, the test item should be considered as a moderate sensitizer.