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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
GLP compliance:
yes (incl. QA statement)
Type of study:
other: LuSens Assay
Justification for non-LLNA method:
This in vitro study evaluates the potential of the test item Gamma Terpinene to activate the Nrf2 transcription factor by using the LuSens cell line. This test is part of a tiered strategy for the evaluation of skin sensitisation potential. Thus, data generated with the present Test Guideline should be used to support the discrimination between skin sensitizers and non-sensitizers in the context of an integrated approach to testing and assessment.

Test material

1
Chemical structure
Reference substance name:
p-mentha-1,4-diene
EC Number:
202-794-6
EC Name:
p-mentha-1,4-diene
Cas Number:
99-85-4
Molecular formula:
C10H16
IUPAC Name:
p-mentha-1,4-diene
Specific details on test material used for the study:
Test Item
Designation in Test Facility: 17022802G
Date of Receipt: 28. Feb. 2017
Condition at Receipt: Room temperature, in proper conditions
Specification
The following information concerning identity and composition of the test item was pro-vided by the sponsor.
Name Gamma Terpinene
Batch no. 161215
Appearance Clear liquid
Composition p-mentha-1,4-diene
Purity 98 %
Homogeneity homogeneous
Expiry date 14. Dec. 2018
Storage Room Temperature (20 ± 5 °C), keep away from light
The following information was provided by the sponsor as well:
CAS No. 99-85-4
EINECS-No. 202-794-6
Molecular formula C10H16
Molecular weight 136.23 g/mol
Vapour pressure 0.9 hPa at 20 °C
Stability H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility H2O: < 0.1 g/L; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Production date 15. Dec. 2016

In vitro test system

Details on the study design:
This in vitro study evaluates the potential of the test item Gamma Terpinene to activate the Nrf2 transcription factor by using the LuSens cell line. This test is part of a tiered strategy for the evaluation of skin sensitisation potential. Thus, data generated with the present Test Guideline should be used to support the discrimination between skin sensitizers and non-sensitizers in the context of an integrated approach to testing and assessment.
The assay included a cytotoxicity range finder test (CRFT) and two independent experi-ments (experiment I and II) with a treatment period of 48 h. The CRFT was performed to detect a potential cytotoxic effect of the test item. Based on the results of this test the con-centrations for the two experiments were determined.
In the experiments, the highest nominal applied concentration (125 µM) was chosen based on the results obtained in the CRFT. A geometric series (factor 1.2) of eleven dilutions thereof was prepared. Precipitation of the test item was not visible in none of the experiments.
DMSO (final concentration: 1 %) was used as solvent control and medium no. 3 as growth control. Lactic acid (5000 µM) was used as negative control and EGDMA (120 µM) as positive control.
The evaluated experimental points and the results are summarised in table 8-a, page 19 and 8-b, page 21.
No substantial and reproducible dose dependent increase in luciferase induction above 1.5 fold was observed in both experiments up to the maximal concentration of the test item.

Results and discussion

Positive control results:
EGDMA (120 µM) was used as positive control. The viability was above 70 % and a dis-tinct increase in luciferase induction above 2.5 fold in comparison to the solvent control was detected.

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
other: experiment I-test item
Parameter:
other: Induction of Luciferase(fold)
Value:
0.1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment I-Solvent Control
Parameter:
other: Induction of Luciferase(fold)
Value:
1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment I-Growth Control
Parameter:
other: Induction of Luciferase(fold)
Value:
1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment I-Negative Control
Parameter:
other: Induction of Luciferase(fold)
Value:
1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment I-Positive Control
Parameter:
other: Induction of Luciferase(fold)
Value:
5.9
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment II-Solvent Control
Parameter:
other: Induction of Luciferase(fold)
Value:
1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment II-Growth Control
Parameter:
other: Induction of Luciferase(fold)
Value:
1.1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment II-Growth Control
Parameter:
other: Induction of Luciferase(FOLD)
Value:
1.1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment II-Negative Control
Parameter:
other: Induction of Luciferase(FOLD)
Value:
1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment II-Positive Control
Parameter:
other: Induction of Luciferase(FOLD)
Value:
8.1
Negative controls validity:
valid
Positive controls validity:
valid
Key result
Run / experiment:
other: experiment II-test item
Parameter:
other: Induction of Luciferase(FOLD)
Value:
0.5
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions of this study, the test item, Gamma Terpinene, was negative in the LuSens assay and is therefore considered not having the potential to acti-vate the Nrf2 transcription factor (no sensitizing potential). In accordance to the OECD 442D the result is inconclusive.