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EC number: 283-634-2 | CAS number: 84696-15-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Zingiber officinalis, Zingiberaceae.
- 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 chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- not specified
- Justification for non-LLNA method:
- The study was performed in order to evaluate the reactivity of the test item Ginger, ext. towards cysteine (Cys-) and lysine (Lys-) containing peptides. The pure test item was in-cubated 24 ± 2 h at 25 °C together with cysteine and lysine peptides, respectively, and the peptide concentration after the incubation was measured using HPLC-UV.
Three replicates were prepared using 1:10 and 1:50 molar ratio of the test item with the Cys- and Lys-peptide, respectively. Triplicate samples of the solvent without test item were incubated and measured in parallel.
The peptide depletion values after incubation are shown in Table 3-a:
Test material
- Reference substance name:
- Ginger, ext.
- EC Number:
- 283-634-2
- EC Name:
- Ginger, ext.
- Cas Number:
- 84696-15-1
- Molecular formula:
- N/A
- IUPAC Name:
- Essential oil extract of Zingiber officinalis (Zingiberaceae) root GINGER ESSENTIAL OIL Ginger Oil Ginger Oleoresin Ginger, ext Ginger, ext. Ginger, Extrakt HE Zingiber officinalis INCI name: Zingiber Officinale (Ginger) Root Extract OILS, GINGER Reaction mass of camphene and pin-2(3)-ene and 7-methyl-3-methyleneocta-1,6-diene and pin-2(10)-ene and cineole and [S-(R*,S*)]-5-(1,5-dimethylhexen-4-yl)-2-methyl-1,3-cyclohexa-1,3-diene and (R)-p-mentha-1,8-diene Zingiber officinalis, Zingiberaceae.
1
Results and discussion
In vitro / in chemico
Results
- Run / experiment:
- other:
- Parameter:
- other: peptide concentration
- Value:
- 6.38
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table8.3–a Calculated peptide depletion values for the Lys-Peptide (Assay 1)
Sample name |
Depletion [%] |
||
Single |
Mean |
SD |
|
Positive control Rep. 1 |
30.20 |
31.57
|
1.48
|
Positive control Rep. 2 |
31.39 |
||
Positive control Rep. 3 |
33.14 |
||
Test item Rep. 1 |
0.00 |
0.00 |
0.00 |
Test item Rep. 2 |
0.00 |
||
Test item Rep. 3 |
0.00 |
Table8.3–b Calculated peptide depletion values for the Lys-Peptide (Assay 2)
Sample name |
Depletion [%] |
||
Single |
Mean |
SD |
|
Positive control Rep. 1 |
33.60 |
36.24
|
2.91
|
Positive control Rep. 2 |
39.36 |
||
Positive control Rep. 3 |
35.75 |
||
Test item Rep. 1 |
0.00 |
0.00 |
0.00 |
Test item Rep. 2 |
0.00 |
||
Test item Rep. 3 |
0.00 |
Table8.3–c Calculated peptide depletion values for the Cys-Peptide (Assay 1)
Sample name |
Depletion [%] |
||
Single |
Mean |
SD |
|
Positive control Rep. 1 |
74.78 |
7.61
|
2.46
|
Positive control Rep. 2 |
78.77 |
||
Positive control Rep. 3 |
79.27 |
||
Test item Rep. 1 |
49.43 |
55.61 |
5.77 |
Test item Rep. 2 |
56.56 |
||
Test item Rep. 3 |
60.85 |
Table8.3–d Calculated peptide depletion values for the Cys-Peptide (Assay 2)
Sample name |
Depletion [%] |
||
Single |
Mean |
SD |
|
Positive control Rep. 1 |
77.73 |
79.69
|
1.71
|
Positive control Rep. 2 |
80.52 |
||
Positive control Rep. 3 |
80.83 |
||
Test item Rep. 1 |
48.71 |
56.19 |
8.18 |
Test item Rep. 2 |
54.93 |
||
Test item Rep. 3 |
64.93 |
Mean depletion of both peptides after incubation with the test item: 27.81 % (Assay 1) and 28.10 % (Assay 2)
1.1.1 Acceptance criteria
a) The mean peptide depletion value for the positive control cinnamaldehyde should be 60.8 % - 100 % with a maximum standard deviation (SD) of < 14.9 % for the Cys-peptide.
b) The mean peptide depletion value for the positive control 2,3-butanedione should be 10 % - 45 % with a maximum standard deviation < 11.6 % for the Lys-peptide.
c) The maximum standard deviation for the test item replicates should be < 14.9 % for the percent cysteine depletion and < 11.6 % for the percent lysine depletion
1.1.2 Assessment
a) The mean peptide depletion and standard deviation of the three replicates of the positive control cinnamaldehyde were in the acceptable range of 60.8 – 100.0 % and ≤ 14.9 %, respectively, for the Cys-peptide.
b) The mean peptide depletion and standard deviation of the three replicates of the positive control 2,3-Butanedione were in the acceptable range of 10.0 – 45.0 % and ≤ 11.6 %, respectively, for the Lys-peptide.
c) The maximum standard deviation for the test item replicates was < 14.9 % for the percent cysteine depletion for the test item.
The maximum standard deviation for the test item replicates was < 11.6 % for the percent lysine depletion for the test item.
1.2 Evaluation of results
According to the test guideline, the reactivity is classified as “high”, “moderate”, “low” or “minimal” using the Cysteine 1:10/Lysine 1:50 prediction model shown in Table8.4–a.
Table8.4–a Evaluation of results according to the Cysteine 1:10/Lysine 1:50 prediction model
Mean peptide depletion |
Reactivity Class |
DPRA Prediction |
0 – ≤ 6.38 |
Minimal |
Negative |
> 6.38 – ≤ 22.62 |
Low |
Positive |
> 22.62 – ≤ 42.47 |
Moderate |
|
> 42.47 - ≤ 100 |
High |
The mean peptide depletion in the Lys-peptide and Cys-peptide assay was 27.81 %, therefore the test had to be repeated for verification of this result. The mean peptide depletion in the Lys-peptide and Cys-peptide in the repeated experiment was 28.10 %. The result of the first experiment was considered verified:
DPRA Prediction: Positive
Reactivity class: Moderate
Applicant's summary and conclusion
- Conclusions:
- POSITIVE
All acceptance criteria were fulfilled, therefore the test was considered valid. The DPRA prediction for the test item Ginger, ext. was positive with reactivity class moderate accord-ing to the Cysteine 1:10/Lysine 1:50 prediction model. The result was verified in a second experiment.
No observations arousing doubts concerning the accuracy of the results and the validity of the study were made.
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