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Diss Factsheets

Administrative data

Description of key information

Sensitising properties of UVCB substance were determined both on the basis of known substance composition (the amount of sensitising components) and on the basis of supporting study. The amount of formaldehyde that is classified as a skin sensitiser is above the specific concentration limit (SCL) set for formaldehyde (0.2 %) and thus triggers the classification as a skin sensitiser.


In the supporting study, the potential of fast pyrolysis bio-oil to induce delayed contact hypersensitivity was assessed using the 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.



Justification for selection of skin sensitisation endpoint:
The potential of fast pyrolysis bio-oil to induce delayed contact hypersensitivity was assessed in BIOTOX project in a guideline study using the murine Local Lymph Node Assay (LLNA). According to study results, the test item should be considered as a moderate sensitizer.

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:
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)).
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
not specified
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)
Species:
mouse
Strain:
other: CBA/J
Sex:
female
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)
Key result
Parameter:
EC3
Value:
ca. 3.2

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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Sensitising properties of UVCB substance were determined on the basis of known substance composition and the amount of sensitising components.

No known components of fast pyrolysis bio-oil are classified as respiratory sensitisers. Thus, based on current knowledge, no classification for the substance itself is necessary.

Justification for classification or non-classification

Sensitising properties of UVCB substance were determined on the basis of known substance composition and the amount of sensitising components. The amount of formaldehyde that is classified as a skin sensitisiser is above the specific concentration limit (SCL) set for formaldehyde (0.2 %) and thus triggers the classification as a skin sensitiser.


No known components of fast pyrolysis bio-oil are classified as respiratory sensitisers. Thus, based on current knowledge, no classification for the substance itself concerning respiratory sensitisation is necessary. Classification criteria is based on CLP regulation (EC) No 1272/2008.