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EC number: 289-753-6 | CAS number: 89998-15-2 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cymbopogon nardus, Gramineae.
- 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
Endpoint summary
Administrative data
Description of key information
Skin Corrosion (OECD TG 431): Not corrosive
Eye Irritation (OECD TG 437): IVIS ≤ 3, not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 May 2018 - 31 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- July 29, 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC method B.40 bis: In vitro Skin Corrosion: Human Skin Test Method.
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 07-07-2016
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek Corporation
- Source strain:
- not specified
- Details on animal used as source of test system:
- Human source
- Justification for test system used:
- According to guideline recommendations
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-200-SCT), Lot no. 28620
- Tissue batch number(s): 00267
- Production date: 30 May 2018
- Date of initiation of testing: 30 May 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: Room temperature
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing steps: After exposure tissues were rinsed, blotted and assay medium was replaced by MTT assay medium
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ mL
- Incubation time: 3h
- Spectrophotometer: Tecan Sunrise Magellan Version 7.2
- Wavelength: 540 nm
FUNCTIONAL MODEL CONDITIONS IN REFERENCE TO HISTORICAL DATA
- Viability: Pass
- Barrier function: Pass
- Morphology: Pass
- Contamination: Pass
- Reproducibility: Pass
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Freeze killed tissues
- Procedure used to prepare the killed tissues: frozen tissues were stored in the freezer (-20 ± 5°C).
- N. of replicates: 2
- Method of calculation used:
True viability = Viability of treated tissue – Interference from test chemical = OD tvt – OD kt
where OD kt = (mean OD tkt – mean OD ukt)
tvt = treated viable tissue kt = killed tissues
tkt = treated killed tissue ukt = untreated killed tissue (NC treated tissue)
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- the test item is considered to be corrosive to skin and classified as category 1 (or optional category 1A ), if the viability after 3 minutes exposure is less than 50%;
- the test item is considered to be corrosive to skin and classified as sub-category 1B-and-1C, if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is less than 15%;
- the test item is considered to be non-corrosive to skin, if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µL
- Concentration (if solution): undiluted
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
- Concentration (if solution): unchanged
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50µL
- Concentration (if solution): 8 N KOH - Duration of treatment / exposure:
- 3 minutes or 1 hour
- Duration of post-treatment incubation (if applicable):
- 3 hour
- Number of replicates:
- Two replicate tissues for each treatment (exposure periods) were employed.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute exposure period
- Value:
- 109.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure period
- Value:
- 78.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: yes
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- The mean optical density (OD) of the negative control of 2 tissues was 2.243 (3 minute exposure) or 2.411 (1-hour exposure) and therefore well within the acceptable range of ≥ 0.8 to ≤ 2.8.
- The viability of cells treated with the positive reference item 8 N KOH was 3.4% or 2.8% (3-minute or 1-hour exposure, respectively) of the negative control and, hence well below the 15% cut-off value at the 1-hour exposure.
- The difference of viability between the two tissue replicates (at 20 - 100% viability) was below the limit of acceptance of 30%. Hence, all acceptance criteria were fulfilled
- Range of historical values if different from the ones specified in the test guideline: see table below in the additional information section. - Interpretation of results:
- other: not corrosive
- Remarks:
- based on CLP criteria (1272/2008/EC).
- Conclusions:
- Based on the results of this study, Citronella nardus oil does not need to be classified for skin corrosion in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
The purpose of this study was to assess the corrosive properties of Citronella nardus oil to human skin, in an experiment according to OECD TG 431 with an artificial three-dimensional model of human skin. The EpiDerm™ model was employed. Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.
Citronella nardus oil was applied topically as supplied (liquid). Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference item. The test item and the reference items were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour.
In comparison to the negative controls, the mean viability of cells exposed to the test item was 109.9% after a 3-minute exposure period and 78.7% after a 1 hour exposure (corrected viability calculated for MTT reducing test items using freeze-killed control tissues) and hence, the 3-minute and the 1-hour exposure values were above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of ≥ 50% and ≥ 15%, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.All acceptance criteria were fulfilled.
Under the present test conditions Citronella nardus oil tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin
Reference
Material |
Average OD (mean% difference ±SD) |
Average viability [%] (mean% difference ±SD) |
Range |
No. of unqualified experi-ments |
|
Viability [%] |
% difference |
||||
Short time incubation – 3‑min |
|||||
Negative control (Non-Corrosive) |
1.624 (2.5±2.4) |
100 (2.5±2.4) |
93.7–106.3 |
0.14–8.6 |
0#1 |
8 N KOH (Corrosive) |
0.126 (8.8±7.4) |
7.6 (8.8±7.4) |
2.0–15.6 |
<0.01–23.7 |
0 |
Long time incubation – 60‑min |
|||||
Negative control (Non-Corrosive) |
1.650 (4.0±5.0) |
100 (4.0±5.0) |
85.6–114.4 |
0.13–18.3 |
0#1 |
8 N KOH (Corrosive) |
0.090 (5.7±9.8) |
5.9 (5.7±9.8) |
2.0–12.6 |
0.30–38.4 |
0#2 |
OD: Optical density. Viability for negative control is set = 100%
SD: Standard deviation
CV: Coefficient of variation
#1 Unqualified results = if the mean OD of the NC tissues is < 0.8 or > 2.8
if difference in viability for duplicate tissues > 30%
#2 Unqualified results = 8 N KOH: viability > 15% (1-hour exposure)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Feb 2018 - 14 Mar 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: cattle
- Characteristics of donor animals (e.g. age, sex, weight): 6 - 60 months of age
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Eyes were collected and transported in physiological saline without antibiotics in a suitable container under cooled conditions.
- Indication of any existing defects or lesions in ocular tissue samples: The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
- Indication of any antibiotics used: no antibiotics used - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 mL
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 10 +/- 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 +/- 10 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine (Life Technologies) and 1% (v/v) Foetal Bovine Serum (Life Technologies)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen, Germany) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32°C. The corneas were incubated for the minimum of 1 hour at 32°C.
QUALITY CHECK OF THE ISOLATED CORNEAS
The opacity of each cornea was read against a cMEM filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 7 were not used. Three corneas were selected at random for each treatment group.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
Yes
SOLVENT CONTROL USED (if applicable)
No
POSITIVE CONTROL USED
Yes
APPLICATION DOSE AND EXPOSURE TIME
Undiluted 750µL, 10 minutes
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: yes 120 +/- 10 minutes
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: untill all substance removed
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance (I = luminous flux per area, unit: lux) by a light meter (measured with the device OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)
DECISION CRITERIA: according to Test Guideline - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main
- Value:
- 2.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
DEMONSTRATION OF TECHNICAL PROFICIENCY: Historical Control Data for the BCOP Studies Feb 2015-2018
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline:
Negative control
- Opacity -2.9 – 3.0 (mean 0.18, SD 1.10, N=113)
- Permeability -0.034 – 0.100 (mean 0.00, SD 0.01, N=113)
- In vitro Irritancy Score -2.8 – 3.0 (mean 0.23, SD 1.13, N=113)
Positive control
- In vitro Irritancy Score 28.0 – 110.9 (mean 55.28, SD 15.14, N=88) - Interpretation of results:
- other: Not irritating to eyes
- Remarks:
- in accordance with Annex I of the CLP Regulation (1272/2008/EC).
- Conclusions:
- Citronella nardus oil induced an IVIS ≤ 3. Based on these results, the test substance does not need to be classified as eye irritant according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The eye irritation potential of Citronella nardus oil was measured by its ability to induce opacity and increase permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test), OECD test guideline 437 under GLP conditions.The negative cotrol, positive control or test item was applied as received, directly on top of the corneas (750 µL) for 10 minutes. Thereafter the eyes were washed and incubated for 120 minutes before evaluating the effects. The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 39 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Citronella nardus oil did not induce ocular irritation through both endpoints, resulting in a meanin vitro irritancy score of 2.6 after 10 minutes of treatment. In conclusion, since Citronella nardus oil induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin corrosion
The purpose of this study was to assess the corrosive properties of Citronella nardus oil to human skin, in an experiment according to OECD TG 431 with an artificial three-dimensional model of human skin. The EpiDerm™ model was employed. Two tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. Citronella nardus oil was applied topically as supplied (liquid). Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference item. The test item and the reference items were applied to the skin model surface at two exposure periods of 3 minutes or 1 hour. In comparison to the negative controls, the mean viability of cells exposed to the test item was 109.9% after a 3-minute exposure period and 78.7% after a 1 hour exposure (corrected viability calculated for MTT reducing test items using freeze-killed control tissues) and hence, the 3-minute and the 1-hour exposure values were above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of ≥ 50% and ≥ 15%, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin. All acceptance criteria were fulfilled. Under the present test conditions Citronella nardus oil tested at two exposure periods of 3 minutes or 1 hour was non-cytotoxic and, hence, predicted to be non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin
Acute dermal toxicity
The acute dermal toxicity of Citronella nardus oil was examined in albino rabbits (method similar to OECD 402, pre-GLP). The undiluted substance was applied at 0.5, 1.0, 2.0, 4.0 or 8.0 mL/kg onto the intact or abraded skin of the animals (2 animals per condition). Based on the results, the LD50 was estimated 4.7 mL/kg bw. However, the report also mentions the appearance of severe burns (intact or abraded skin was not specified). Therefore, though the substance is considered to be not acute toxic via the dermal route, it is likely to be a skin irritant.
Eye irritation
The eye irritation potential of Citronella nardus oil was measured by its ability to induce opacity and increase permeability in an isolated bovine cornea using the Bovine Corneal Opacity and Permeability test (BCOP test), OECD test guideline 437 under GLP conditions. The negative cotrol, positive control or test item was applied as received, directly on top of the corneas (750 µL) for 10 minutes. Thereafter the eyes were washed and incubated for 120 minutes before evaluating the effects. The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 39 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Citronella nardus oil did not induce ocular irritation through both endpoints, resulting in a meanin vitro irritancy score of 2.6 after 10 minutes of treatment. In conclusion, since Citronella nardus oil induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Justification for classification or non-classification
Based on the available endpoint specific skin corrosion information, the test substance does not need to be classified for skin corrosion in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC). However, as in vivo data (acute dermal toxicity study in rabbits) has shown that the substance is a potential skin irritant, Citronella nardus oil will be classified as Skin Irrit. 2, H315 Causes skin irritation.
In conclusion, since Citronella nardus oil induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
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