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EC number: 289-969-0 | CAS number: 90046-02-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Juniperus oxycedrus, Cupressaceae.
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 October 2019 - 04 October 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Juniper, Juniperus oxycedrus, ext.
- EC Number:
- 289-969-0
- EC Name:
- Juniper, Juniperus oxycedrus, ext.
- Cas Number:
- 90046-02-9
- IUPAC Name:
- Empyreumatic oil obtained from Juniperus oxycedrus (Cupressaceae) wood by dry distillation
- Test material form:
- liquid
- Details on test material:
- - Appearance: brown liquid
- Density (20ºC): 1.017
- Refractive index (20ºC): 1.533
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™ model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not specified
- Source strain:
- not specified
- Justification for test system used:
- The EpiDerm™ model has been validated for irritation testing (Validation study based on the original ECVAM Performance Standards (21) in 2008) and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439); therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™ (EPI-218-SIT)
- Tissue batch number(s): 30829
- Production date: 30.09.2019
- Delivery date: 01.10.2019
- Date of initiation of testing: 01.10.2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37ºC for 35 min and room temperature for 25 min.
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 15-times with DPBS at 1-minute-intervals
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µL of a MTT solution at 1.0 mg/mL
- Incubation time: 3 hours at 37°C, 5% CO2, 90 RH
- Spectrophotometer: Microplate reader: FLUOstar Omega (BMG Labtech)
- Wavelength: 570 nm
- Linear OD range of spectrophotometer: linear range of 0.0 – 3.0.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD=1.82 (specification 1< OD < 3). Historical negative control mean OD range = 0.883-2.960.
- Barrier function: 6.45 h (Specification 4.77h < ET50< 8.72h)
- Morphology: appropriate formation of the epidermal barrier, the presence of a functional stratum corneum, a viable basal cell layer and intermedaite spinous and granular layers.
- Contamination: no
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE: 2 freeze-killed control tissues.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin (or corrosive) if the viability after 60 minutes exposure and 42 hours of post-treatment incubation is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after 60 minutes exposure and 42 hours of post-treatment incubation is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL (47 μL/cm2)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 13.7
- 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: in the pre-test for assessment of direct reduction of MTT by the test item, the MTT solution turned blue/purple, so the test item was presumed to have reduced the MTT and additional control (NSMTT) was performed. However, the relative viability of tissue treated with the test item was ≤ 50 % compared to the negative control (positive result) and thus the true tissue viability calculation was not necessary.
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes. A full demonstration of proficiency was performed and the 10 of 10 proficiency substances were correctly classified.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, SD of the negative control group was 6.7% (acceptablility criteria, SD ≤ 18%) and OD mean was 1.423 (acceptability criteria, ≥ 0.8 and ≤ 2.8).
- Acceptance criteria met for positive control: yes, SD of the positive control group was 0.4% (acceptablility criteria, SD ≤ 18%) and mean viability was 3.1% (acceptability criteria, < 20 %).
- Acceptance criteria met for variability between replicate measurements: yes. SD of test item was 2.3% (acceptablility criteria, SD ≤ 18%).
Any other information on results incl. tables
Table 1. Blank corrected absorbance values (OD 570 nm)
OD 570 nm |
Negative control |
Positive control |
Test item: CADE OIL, RECTIF. (EX-JUN.OXYC) |
||||
Tissue number |
Measurement replicate |
OD 570 nm |
Mean |
OD 570 nm |
Mean |
OD 570 nm |
Mean |
1 |
A |
1.531 |
1.543 |
0,042 |
0,051 |
0,185 |
0,179 |
B |
1.555 |
0,059 |
0,174 |
||||
2 |
A |
1.341 |
1.342 |
0,040 |
0,039 |
0,171 |
0,168 |
B |
1.343 |
0,038 |
0,165 |
||||
3 |
A |
1.390 |
1.384 |
0,042 |
0,042 |
0,235 |
0,236 |
B |
1.378 |
0,041 |
0,237 |
||||
Mean of the three tissues |
1,423 |
0.044 |
0.194 |
Table 2. Tissue viability [%]
|
Negative control |
Positive control |
Test item: CADE OIL, RECTIF. (EX-JUN.OXYC) |
Tissue no. 1 viability |
108.4 |
3.6 |
12.6 |
Tissue no. 2 viability |
94.3 |
2.7 |
11.8 |
Tissue no. 3 viability |
97.2 |
2.9 |
16.6 |
Mean Tissue viability |
100 |
3.1 |
13.7 |
SD (±) |
6.7 |
0.4 |
2.3 |
%CV |
6.7 |
12.4 |
16.7 |
Table 3. Historical data of absorbance values for negative and positive controls
|
Negative Control DPBS buffer |
Positive Control 5 % SDS |
Mean OD 570 nm |
2.038 |
0.042 |
Standard deviation (SD) |
0.437 |
0.007 |
Minimum |
0.883 |
0.029 |
Mean -SD |
1.164 |
0.028 |
Maximum |
2.960 |
0.059 |
Mean +2SD |
2.912 |
0.056 |
In above table the means of OD 570 nm for the negative controls and positive controls of all performed experiments up to 04. Oct. 2019 are stated and compared with the values which were found in this study.
Applicant's summary and conclusion
- Interpretation of results:
- other: classified as corrosive (Cat 1) or irritant (Cat 2) (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test item is considered to be irritating / corrosive to skin (category 1 or 2) in the Reconstructed human Epidermis (RhE) Test Method.
- Executive summary:
An in vitro skin irritation test of the test item was performed in a reconstructed human EpiDerm™ model, according to OECD TG 439 (GLP study). Three epidermis units were treated with 30 μL test item for 60 minutes. Exposure of the test item was terminated by washing the tissues 15-times with DPBS at 1-minute-intervals. The tissues were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues with MTT for 3 hours at 37 ºC, 5 % CO2 and 90 RH, extracting the precipitated formazan crystals using isopropanol during 2 hours at room temeprature, and measuring the concentration of formazan by determining the absorbance (OD at 570 nm). DPBS-buffer was used as negative control and 5% SDS solution was used as positive control. All acceptance criteria (absorbance value for negative control, mean value of relative tissue viability of positive control, variation within the tissue replicates) were within the appropriate range. Therefore, the experiment was considered as valid. After the treatment with the test item, the mean value of relative tissue viability was reduced to 13.7 %. This value is below the threshold for skin irritation potential (≤ 50%). Therefore, the test item is considered as skin irritant (cat 2) or skin corrosive (Cat 1).
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