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EC number: 283-415-1 | CAS number: 84625-40-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Trigonella foenum-graecum, Leguminosae.
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study carried out between 09 February and 21 February 2018.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 431 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Remarks:
- French GLP Compliance Programme for chemical products (inspected on 30-31 January 2017 / signed on 27 April 2017)
Test material
- Reference substance name:
- Fenugreek, ext.
- EC Number:
- 283-415-1
- EC Name:
- Fenugreek, ext.
- Cas Number:
- 84625-40-1
- Molecular formula:
- Not applicable (UVCB)
- IUPAC Name:
- Absolute of Trigonella foenum graecum L. (Leguminosae) obtained from seeds by organic solvent treatment and subsequent ethanol extraction
- Test material form:
- liquid: viscous
- Remarks:
- Brown-yellow viscous liquid
- Details on test material:
- Test item: Fenugreek Absolute
Batch No.: 2709379
Identity: 100 % UVCB Substance
Appearance: Brown-yellow viscous liquid
Storage conditions: Ambient temperature (10 °C to 30 °C), in original aluminium bottle, dark
Expiry date: October 24, 2018
Constituent 1
- Specific details on test material used for the study:
- Test item was identified under the following code number: PH-17/0759
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Not precised
- Source strain:
- other: Not applicable
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- Following the REACH bottom-up strategy, as the result of the OECD test guideline No. 439 was positive, the epiCS® Reconstructed Human Epidermis Model method was used to assess skin corrosion as recommended in the OECD test guideline No. 431.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
The test item was applied, as supplied, at the dose of 50 µL to 2 living and 4 killed Human skin model surfaces during 3 minutes at room temperature and during 1 hour at 37°C ± 1°C, 5% ± 1% CO2. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
50 µL of test item
- Concentration (if solution):
Not applicable: undiluted
VEHICLE
not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
50 µL of distilled water
- Concentration (if solution):
Not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
50 µL of potassium hydroxide 8N (8N KOH)
- Concentration (if solution): Not applicable - Duration of treatment / exposure:
- 3 min at room temperature or 1 hour at 37°C ± 1°C, 5% ± 1% CO2
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- 2 tissues per condition
Triplicate measurement of OD570 for each tissue.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 73.28
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- The mean OD of negative control tissues after 3 minutes exposure was 0.691(between 0.233 and 0.933)
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 101.43
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- The mean OD of negative control tissues after 3 minutes exposure was 0.771 (between 0.233 and 0.933)
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 7.3.1/1: Individual and average values after 3 minutes exposure
|
Skin |
OD |
Mean OD / disc (#) |
Mean OD / product |
Viability % |
Mean viability % |
SD |
Negative control |
1 |
0.669 0.688 0.701 |
0.686 |
0.691 |
99.35 |
100.0 |
1.3 |
2 |
0.715 0.652 0.717 |
0.695 |
100.65 |
||||
Positive control |
3 |
0.025 0.025 0.024 |
0.025 |
0.042 |
3.62 |
6.08 |
4.9 |
4 |
0.059 0.058 0.059 |
0.059 |
8.54 |
||||
Test item |
13 |
0.418 0.403 0.415 |
0.412 |
0.506 |
59.67 |
73.28 |
27.2 |
14 |
0.603 0.600 0.596 |
0.600 |
86.89 |
#: mean of 3 values
OD: optical density
Table 7.3.1/2: Individual and average values after 1 hour exposure
|
Skin |
OD |
Mean OD / disc (#) |
Mean OD / product |
Viability % |
Mean viability % |
SD |
Negative control |
15 |
0.856 0.834 0.835 |
0.892 |
0.771 |
109.28 |
100.0 |
18.6 |
16 |
0.710 0.676 0.711 |
0.699 |
90.72 |
||||
Positive control |
17 |
0.004 0.004 0.004 |
0.004 |
0.003 |
0.52 |
0.39 |
0.3 |
18 |
0.002 0.002 0.002 |
0.002 |
0.26 |
||||
Test item |
27 |
0.661 0.627 0.626 |
0.638 |
0.782 |
82.80 |
101.43 |
37.2 |
28 |
0.961 0.907 0.906 |
0.925 |
120.05 |
#: mean of 3 values
OD: optical density
Table 7.3.1/3: Conclusion
Mean viability (%) |
|||
3 min exposure |
1 hour exposure |
Conclusion |
|
Positive control |
6.08 |
0.39 |
Corrosive sub-category 1B/1C |
Test item |
73.28 |
101.43 |
Non Corrosive |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item FENUGREEK ABSOLUTE does not have to be
classified in Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are not required. - Executive summary:
The aim of the study was to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (epiCS®, CellSystems®).
The test item FENUGREEK ABSOLUTE was applied as supplied, at the dose of 50 μL, to 2 living Human skin model surfaces (epiCS®, CellSystems®) during 3 minutes and 1 hour. The application was
followed by a rinse with 20 mL of DPBS. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from
tissues. The experimental protocol was established in accordance with the O.E.C.D. Test Guideline No. 431 dated 28 July 2015 and the method B.40bis of the Council regulation No. 440/2008.
3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis skins treated with the test item were 73.28% and 101.43% (considered as 100%) versus 6.03% and
0.39%, respectively; with the positive control item (potassium hydroxide 8N).
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item FENUGREEK ABSOLUTE does not have to be
classified in Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are not required.
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