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Administrative data

Description of key information

Two studies are available on the skin sensitisation endopoint.

The first (key) is a Local Lymph Node Assay in the mouse (LLNA), which was was performed at Harlan Laboratories in 2012 to investigate the skin sensitisation potential of Terpenes and terpenoids, turpentine oil, alpha pinene fraction oligomers. The study was performed according to the OECD 429 and under GLP conditions. 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.

The same study (supporting) was performed at Harlan Laboratories in 2012 to investigate the skin sensitisation potential of the simlar substance Terpenes and terpenoids, turpentine oil, beta pinene fraction oligomers. The study was performed according the OECD Guideline 429 and under GLP conditions.

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Remarks:
In vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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)
Specific details on test material used for the study:
Test Material: Terpenes and terpenoids, turpentine oil, alpha pinene fraction oligomers
Description: extremely viscous fraction oligomers
CAS 70750-57-1
Batch Number: 0910002624
Purity: 100%
Date received: 14 March
Expiration date: Indefintive
Storage: room temperature in the dark
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
Vehicle:
other: butanone
Concentration:
Mice were treated by daily application of 25 μl of the test material at concentration of 25% or 50% w/w in butanone.
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.
Statistics:
The proliferation response of lymph node was expressed as the number of radioactive disintegrations per minutes per lymph node and as the ratio of 3HTdR incorporation into lymph node cells of the test nodes relative to that recorded for the control nodes. (SI).
Key result
Parameter:
SI
Value:
1.31
Remarks on result:
other: Concentration 5% w/w in butanone
Key result
Parameter:
SI
Value:
1.04
Remarks on result:
other: 10% w/w in butanone
Key result
Parameter:
SI
Value:
2.94
Remarks on result:
other: 25% w/w in butanone
Cellular proliferation data / Observations:
Clinical Observation: Mild (very slight) erythema on the ears was noted in animals treated with the test item at a concetration of 25% w/W in butanone. There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.

Body weight: One animal, treated with the test ite, at concentration of 10% w/w in butanone, showed a slightly greater than expected bodyweight loss (3g) over the test period. Bodyweight changes of the remaining test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals.
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 study was performed according to the OECD 429 and under GLP conditions. 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)

Justification for classification or non-classification

Not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 orUN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).