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EC number: 202-794-6 | CAS number: 99-85-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
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:
- 2 017
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
- 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
1
- 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.
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