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EC number: 950-727-0 | CAS number: -
- 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
Not skin and eye irritating (not classified).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 November 2019 - 20 January 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identification/Synonym FENUGREEK EXTRACT
Substance type UVCB substance
EC No. 950-727-0
Storage conditions room temperature, protected from light - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from multiple donors
- Source strain:
- not specified
- Details on animal used as source of test system:
- Multi-layered, highly differentiated epidermis consisting of organized basal, spinous and granular layers, and a multilayered stratum corneum
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
EPISKIN™ - 0.38 cm2
- Quality control for skin discs: Histology scoring, magnitude of viability and barrier function (IC50 determination).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C, 5 %CO2
- Temperature of post-treatment incubation: 37°C, 5 %CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing: 25mL of sterile D-PBS
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Wavelength: 595 nm
Study Acceptability Criteria
The assay was considered valid if the following criteria were met:
– Blank controls: mean OD value < 0.1.
– Negative controls: mean OD value ≥ 0.6 and ≤ 1.5, SD of % viability ≤ 18.
– Positive controls: mean viability expressed as percentage of the negative control
≤ 40% and SD of % viability ≤ 18.
– Test item: SD of % viability ≤ 18
Criteria Classification
Mean relative viability ≤ 50% UN GHS Category 2 or 1
Mean relative viability > 50% UN GHS No Category (for member states that do not adopt optional Category 3) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 20 ± 2mg
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied: 20 µL
- Concentration: 5% D-PBS
POSITIVE CONTROL
- Amount(s) applied: 20 µL
- Concentration: 5% (w/v) SDS - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- Recovery 42 ± 1 hour
MTT staining 3 hours - Number of replicates:
- Live tissue 3 per conditions
Killed tissue at least 2 per conditions - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Live Tissue
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Killed Tissue
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Study Acceptability Criteria
The assay was considered valid if the following criteria were met:
– Blank controls: mean OD value < 0.1.
– Negative controls: mean OD value ≥ 0.6 and ≤ 1.5, SD of % viability ≤ 18.
– Positive controls: mean viability expressed as percentage of the negative control
≤ 40% and SD of % viability ≤ 18.
– Test item: SD of % viability ≤ 18
Criteria Classification
Mean relative viability ≤ 50% UN GHS Category 2 or 1
Mean relative viability > 50% UN GHS No Category (for member states that do not adopt optional Category 3) - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean cell viability of the test item treated tissues, after the blank subtraction, was 94%. Based on the results obtained, the test item is classified as non-irritant to the skin (UN GHS No Category).
Reference
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:
- 25 November 2019 - 11 December 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identification/Synonym FENUGREEK EXTRACT
Substance type UVCB substance
EC No. 950-727-0
Recommended storage Ambient (18-20°C) and protected from temperatures below 4°C; dry (< 70% rh);
conditions to be stored under dark conditions - Species:
- chicken
- Strain:
- other: Ross 308
- Details on test animals or tissues and environmental conditions:
- Head collection was performed by a slaughter house technician. Heads were removed immediately after sedation of the chickens. The heads were transported at the earliest convenience for use approximately within 2 hours from collection. The ambient temperature was optimal (19.3ºC to 20.2ºC) during the transport. After collection, the heads were inspected for appropriate quality and wrapped with paper moistened with saline, then placed in a plastic box that can be closed (4-5 heads/box).
- Amount / concentration applied:
- Used as such, whole surface of eye covered
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- The control and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
- Number of animals or in vitro replicates:
- 3 samples
3 positive controls (acetid acid)
1 negative control ( NaCl solution) - Details on study design:
- SELECTION AND PREPARATION OF ISOLATED EYES
A Drop of fluorescein solution was applied onto the cornea surface and rinsed off with isotonic saline. Checking of the integrity of the cornea, removing of the eyeball. Unnecessary material was removed from the eye. Eye was fixed with steel clamp in vertical position.
EQUILIBRATION AND BASELINE RECORDINGS
At the end of the acclimatization period, a zero reference measurement was recorded for cornea thickness and opacity to serve as a baseline (t=0) for each individual eye. The cornea thickness of the eyes should not change by more than ±5-7 % within approximately 45 to 60 minutes before the start of application. Changes in thickness were not observed in the eyes. Following the equilibration period, the fluorescein retention was measured. Baseline values were required to evaluate any potential test item related effects after treatment.
NUMBER OF REPLICATES
3 samples
NEGATIVE CONTROL USED
1 negative control ( 30 µL saline solution)
POSITIVE CONTROL USED
3 positive controls (30 µL 10 % w/w acetid acid)
APPLICATION DOSE AND EXPOSURE TIME
undiluted
10 seconds
OBSERVATION PERIOD
30, 75, 120, 180 and 240 minutes
REMOVAL OF TEST SUBSTANCE
Cornea surface was rinsed thoroughly with saline solution at ambient temperature. - Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 75 min
- Value:
- 2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 240 min
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Value:
- 0.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein retention score
- Value:
- 0.2
- Other effects / acceptance of results:
- Tables of ICE classification, see tables attached below.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The overall ICE score was 3xI. According to the guideline OECD 438, Test Substance is categorized as “No Category”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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