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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
Endpoint summary
Administrative data
Description of key information
According to clinical study (human repeat patch test) test item was considered as non-irritating and non-sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Human Repeat Insult Patch Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 January to 16 March 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- MARZULLI-MAIBACH METHOD: The Marzulli-Maibach test is a reference test to study the sensitizing potential of a product. The investigational product was applied under maximized conditions (occlusion) during 3 weeks (Induction phase). After a two-week resting period, the investigational product was re-applied on the same site (Challenge phase). If the investigational product was allergenic, it induced a cutaneous reaction during the challenge phase.
- GLP compliance:
- no
- Remarks:
- Good clinical practice
- Type of study:
- other: Study with volunteers
- Justification for non-LLNA method:
- Available study on volunteers
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Robertet / 1968538
- Appearance: Orange-Brown Solid - Species:
- other: Human
- Strain:
- other: Not relevant
- Sex:
- male/female
- Details on test animals and environmental conditions:
- - Number of subjects recruited: 115
- Number of subjects exposed: 102
- Sex: 26 men and 76 women - Positive control results:
- No positive control
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- FENUGREEK ABS 220275 1% (456 µg/cm2) EtOH/DEP(25/75) lot 1968538
- No. with + reactions:
- 0
- Total no. in group:
- 102
- Clinical observations:
- No significant clinical manifestation of intolerance or allergy was observed by the investigator.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: Non performed
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- other: Non performed
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the investigational product FENUGREEK ABS 220275 1% (456 µg/cm2) EtOH/DEP(25/75) tested undiluted, under semi occlusive patch, can be considered as non-sensitizing.
- Executive summary:
A cutaneous tolerance and sensitizing potential study of the investigational product, FENUGREEK ABS 220275 1% (456 µg/cm2) EtOH/DEP(25/75) tested undiluted was conducted by patches application, according to the Marzulli-Maibach sensitization method. The data of 102 female and male subjects aged from 19 to 63 years old were analyzed during the study. The subjects were willing and able to give a written informed consent. The study was carried out at the clinical unit of Skopje in MACEDONIA. The study was blinded and randomized.
Duration:Induction phase: 3 weeks (3 times a week during 48 hours or 72 hours); Duration Resting phase: 14 days; Challenge phase: 1 week (once during 48 hours)
INDUCTION PHASE: During the Induction Phase, the investigational product was applied (160 µL) on a predetermined site under semi occlusive patch (back). A semi-occlusive patch receiving no product was applied in the same conditions and was considered as a non-treated control. Each time, the patches (treated and non-treated) remained applied during 48 or 72 hours before removal and replaced on the same site.
RESTING PHASE: During the 14-day Resting Phase, no product was applied on the sites used during the Induction phase or on the contralateral split-back which was used during the Challenge phase.
CHALLENGE PHASE: During the challenge phase (Day 34/36*), the investigational product was applied under semi occlusive patch on the induction sites and on the contralateral sites. A semi occlusive patch receiving no product was applied in the same conditions and was considered as a non-treated control. The patches (treated and non-treated) remained applied during 48 hours and removed afterwards.
A clinical examination was performed by the investigating dermatologist during the Induction Phase on Days 1, 3, 5/6, 8, 10,12/13,15, 17,19/20 and 22/24,and during the Challenge Phase on Days 34/36, 36/38, 37/39 and 38/40.
During the induction phase, no sign was observed on the control site and the investigational product site. During the challenge phase, no sign was observed on the control site and on the investigational product site, neither on the homolateral side nor on the controlateral site. In this study, no adverse event or serious adverse event was observed by the investigating dermatologists. No significant clinical manifestation of intolerance or allergy was observed by the investigator. The investigational product presents an irritation index of: Z = 0.000; the investigational product is therefore considered as practically non-irritant.
Under the conditions of the study, the investigational product FENUGREEK ABS 220275 1% (456 µg/cm2) EtOH/DEP(25/75) tested undiluted, under semi occlusive patch, can be considered as non-sensitizing.
Referenceopen allclose all
Table 7.10.4/1: Induction phase – results
Days |
Investigational product |
% of subjects - reaction |
Semi-Occlusive control |
% of subjects - reaction |
Day 1 |
Normal examination |
0 |
Normal examination |
0 |
Day 3 |
No reaction |
0 |
No reaction |
0 |
Day 5/6* |
No reaction |
0 |
No reaction |
0 |
Day 8 |
No reaction |
0 |
No reaction |
0 |
Day 10 |
No reaction |
0 |
No reaction |
0 |
Day 12/13* |
No reaction |
0 |
No reaction |
0 |
Day 15 |
No reaction |
0 |
No reaction |
0 |
Day 17 |
No reaction |
0 |
No reaction |
0 |
Day 19/20* |
No reaction |
0 |
No reaction |
0 |
Day 22 |
No reaction |
0 |
No reaction |
0 |
Day 24** |
No reaction |
0 |
No reaction |
0 |
* Subjects no. 104, 105, 106, 107 and 108 began the study 2 days later, so they did not have any visit at Day 5, Day 12 and Day 19, but at Day 6, Day 13 and Day 20.
** Additional application day for subjects no. 3, 13, 67, 69, 89, 95, 97 and 103 as they did not have any application nor reading performed one day during the induction phase.
Table 7.10.4/2: Challenge phase – results
Days |
Sites |
Investigational product |
% of subjects - reaction |
Semi-Occlusive control |
% of subjects - reaction |
Day 34/36* |
H |
Normal examination |
0 |
Normal examination |
0 |
C |
Normal examination |
0 |
Normal examination |
0 |
|
Day 36/38* |
H |
No reaction |
0 |
No reaction |
0 |
C |
No reaction |
0 |
No reaction |
0 |
|
Day 37/39* |
H |
No reaction |
0 |
No reaction |
0 |
C |
No reaction |
0 |
No reaction |
0 |
|
Day 38/40* |
H |
No reaction |
0 |
No reaction |
0 |
C |
No reaction |
0 |
No reaction |
0 |
H: homolateral site;C: contralateral site
* Subjects no.104, 105, 106, 107 and 108 began the study2days later, therefore their challenge phase was performed on Day34,Day 36,Day37and Day38instead of Day36,Day38,Day39and Day 40.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Under the conditions of the study, the investigational product FENUGREEK ABS 220275 1% (456 µg/cm2) EtOH/DEP(25/75) tested undiluted, under semi occlusive patch, can be considered as non-sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a human repeat insult patch test, the test item was concluded to be non-irritating and non-sensitising.
Based on this result and due to the nature of the main constituents of the registered substance, the registered substance does not need to be classified as skin sensitiser.
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