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Description of key information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant and OECD/EU Method Guidelines. No restrictions, do deviations, fully valid for assessment.
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd. Oxon, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 15-23 g
- Housing: The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature : 19-25°C
- Humidity: 30-70%
- Air changes (per hr):
- Photoperiod: 12h dark, 12 h light
Concentration / amount:
25%, 10%, 5% w/w butanone
Concentration / amount:
25%, 10%, 5% w/w butanone
No. of animals per dose:
4 mice per group + control
Positive control substance(s):
yes
Remarks:
vehicle alone
No. of animals per dose:
4
Details on study design:
The preliminary test showed no systemic toxicity or excessive local skin irritation at the highest suitable concetration. Daily application of 25µl of the appropriate concentration of the test item was applied to the dorsal surface of each ear for three consecutive days. Five days following the first topical application all mice were injected via the tail vein with 250 µl of phosphate buffered saline (PBS) containing 3H-methyl thymidine giving a total of 20 µCi to each mouse.
Parameter:
SI
Remarks on result:
other: Concentration 5% w/w in butanone: 1.31 Concentration 10% w/w in butanone: 1.04 Concentration 25% w/w in butanone: 2.94
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Vehicle: 10498.34 Concentration 5% w/w in butanone: 13729.04 Concentration 10% w/w in butanone: 10916.45 Concentration 25% w/w in butanone: 30825.74
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered to be a non-sensitiser under the condition of this test.
Executive summary:

A LLNA test was performed to investigate the skin sensitisation potential of Terpenes and terpenoids, turpentine oil, alpha pinene fraction oligomers. The test item was applied onto the dorsal surface of the ear of CBA/Ca strain female mice. Following a preliminary screening test in which no systemic toxicity was recorded at concentration of 25% w/w, this concentration was selected as the highest dose investigated. The results were expressed as Simulation Index (SI) and under the condition of the study, the test item was considered to be a non-sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A LLNA test was performed to investigate the skin sensitisation potential of Terpenes and terpenoids, turpentine oil, alpha pinene fraction oligomers. Following a preliminary screen, the test substance was applied onto the dorsal surface of the ears of CBA/Ca strain female mice at concentrations of 5%, 10% and 25% (w/w) in butanol. Very slight erythema was noted in animals from the highest treatment groups, however the Stimulation Index was <3 in all cases. Under the condition of the study, the test item was not a sensitiser.


Migrated from Short description of key information:
A LLNA test showed that Terpenes and terpenoids, turpentine oil, alpha pinene fraction oligomers was not a sensitiser.

Justification for classification or non-classification

Based on the available studies and in accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.