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EC number: 281-984-0 | CAS number: 84082-36-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Medicago sativa, 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
LD50 (oral) >3000 mg/kg bw (alfalfa-derived products oral suppplements)
LD50 (oral) >2250 mg/kg bw (phyto-preparation of alfalfa extract)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Seven experimental groups (n = 3) were assigned randomly. The alfalfa derived products were orally administered at 1500 and 3000 mg/kg at a single administration in three independent experiments and one group was used as control (treated only with water). The survival rate was measured 24 and 48 h after treatment and results were reported as percentage of survival.
- GLP compliance:
- not specified
- Remarks:
- Study was performed in a research laboratory, probably none GLP compliant.
- Test type:
- standard acute method
- Specific details on test material used for the study:
- Test material
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Alfalfa-derived products for human consumption 1) freeze-dried juice obtained from fresh aerial parts by squeezing (FDJ), 2) dried and powdered residual material (RM). Both were manufactured from two different harvests, one in May (B1) and the other in August (B2) 2014.
- Expiration date of the lot/batch: 10.09.2019
- Purity test date: not available
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not available
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: none
- Final preparation of a solid: not applicable
OTHER SPECIFICS: none - Species:
- rat
- Strain:
- Wistar
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 250-300 g
- Fasting period before study: not specified
- Housing: standard conditions as outlined in the Mexican Official Standard NOM-062-ZOO-1999
- Diet: ad libitum:
- Water: ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
As outlined in the Mexican Official Standard NOM-062-ZOO-1999 - Route of administration:
- oral: gavage
- Doses:
- 1500 and 3000 mg/kg as a single administration
- Control animals:
- yes
- Details on study design:
- Seven experimental groups (n = 3) were assigned randomly. The FDJ B1 and B2, and RM B1 and B2 were orally administered at 1500 and 3000 mg/kg at a single administration in three independent experiments. One group was used as control (treated only with water). The survival rate was measured 24 and 48 h after treatment and results were reported as percentage of survival.
- Statistics:
- Results were analyzed using Minitab 15. One-way analysis of variance (ANOVA) and two-way ANOVA were used to determine the difference between treatments. Post hoc comparisons of the means were performed according to Tukey and Bonferroni tests depending on the experiments. P < .05 was considered significant.
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Mortality:
- No altterations on survival were observed with 1500 mg/kg body weight for both FDJ and RM from both harvest times (B1 and B2).
88% survival rate was found when 3000 mg/kg body weight of FDJ from B1 harvest time was administered. - Clinical signs:
- other: Not specified
- Gross pathology:
- Not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in Wistar rats, a LD50 value for alfalfa-derived products was determined at >3000 mg/kg body weight.
- Executive summary:
Adult Wistar rats were administered two different concentrations (1500 and 3000 mg/kg body weight) of two alfalfa-derived products (freeze-dried juice and dried and powdered residual material from 2 alfalfa harvest batches). Alfalfa-derived products were administered as a single dose in three independent experiments; and the control group animals received water. The survival rate was measured 24 and 48 hours after treatment. No alterations on survival were observed with 1500 mg/kg body weight dose after 24 and 48 hours. However, after 48 hours, only 88% of survival was found when 3000 mg/kg body weight of freeze-dried juice from one of the batches (B1) was administered. Based on the experiments, the alfalfa-derived products were considered of low acute toxicity under conditions of this experiment.
The value of LD50 in this study has been determined at >3000 mg/kg body weight, therefore, GHS criteria for acute oral toxicity were not met for alfalfa-derived products.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: study not well documented
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Method poorly described.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Specific details on test material used for the study:
- Phytopreparation of Alfalfa (Medicago sativa) extract
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Doses:
- 2250-7500 mg/kg body weight
- No. of animals per sex per dose:
- Not specified
- Statistics:
- Litchfield-Wilcoxon method
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 250 mg/kg bw
- Mortality:
- Not observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats, a LD50 value for alfalfa extract phytopreparation was determined at >2250 mg/kg body weight.
- Executive summary:
No symptoms of poisoning of death were observed when rats were administered a phyto-preparation of alfalfa extract at doses between 2250 and 7500 mg/kg body weight.
The value of LD50 in this study has been determined at >2250 mg/kg body weight, therefore, GHS criteria for acute oral toxicity were not met for alfalfa extract phytopreparation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
Additional information
Adult Wistar rats were administered two different concentrations (1500 and 3000 mg/kg body weight) of two alfalfa-derived products (freeze-dried juice and dried and powdered residual material from 2 alfalfa harvest batches B1/B2). Alfalfa-derived products were administered as a single dose in three independent experiments; and the control group animals received water. The survival rate was measured 24 and 48 hours after treatment. No alterations on survival were observed with 1500 mg/kg body weight dose after 24 and 48 hours. However, after 48 hours, only 88% of survival was found when 3000 mg/kg body weight of freeze-dried juice from one of the batches (B1) was administered. Based on the experiments, both alfalfa-derived products were considered of low acute toxicity under conditions of this experiment.
No symptoms of poisoning of death were observed when rats were administered a phyto-preparation of alfalfa extract at doses between 2250 and 7500 mg/kg body weight.
Additionally, there were no indications of adverse effects after administration of a single dose of 5000 mg/kg body weight of alfalfa protein concentrate (unpublished study cited in EFSA, 2009).
Justification for classification or non-classification
Appropriate tests were performed on the suitable analogues of Alfalfa, ext. to assess its potential to cause acute toxicity by oral route. The analogue substances were concidered of low acute toxicty under the conditions of the experiments (>2000 mg/kg bw/day), therefore, based on these results, it is concluded that Alfalfa, ext. does not meet the criteria for classification as acutely toxic by oral route in accordance with Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging.
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