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EC number: 207-623-9 | CAS number: 485-72-3
- 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
Formononetin is not considered to be acutely harmful by the oral or dermal routes.
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
- Study period:
- 6 February - 3 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- - Lot No. of test material: 07-170-FIL-2/3
- Appearance: White powder
- Expiration date: May 2010
- Purity: 98.4%
- Storage condition of test material: Room temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Texas Animal Specialties, Humble, TX
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 9 weeks old
- Weight at study initiation: 200 - 205 g (Day 1 weight); 186 - 190 g (Day 0 fasted weight)
- Fasting period before study: 16 hours before dosing
- Housing: Suspended, wire bottom, stainless steel cage; 1 animal per cage
- Diet: PMI Feeds Inc. Formulab #5008 available ad libitum
- Water: Municipal water supply available ad libitum from automatic water system
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 12 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: 25 February - 13 March 2008 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40% w/v suspension
MAXIMUM DOSE VOLUME APPLIED: 12.5 mL/kg dose was administered - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations for mortality and clinical/ behavioural signs of toxicity: at least three times on the day of dosing (Day 0) and at least once daily thereafter for 14 days
- Frequency of weighing: Individual body weights were recorded just prior to dosing and on days 7 and 14 or at the time of discovery after death
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- There was no mortality during the study.
- Clinical signs:
- other: All animals appeared normal for the duration of the study.
- Gross pathology:
- The gross necropsy conducted at termination of the study revealed no observable abnormalities.
- Other findings:
- - Actual temperature: 20 - 24°C
- Actual relative humidity: 27 - 90% (Humidity was outside of the protocol range but did not affect the study outcome) - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 of the test substance, Formononetin, is estimated to be greater than 5000 mg/kg.
Reference
Table 1: Body weights, time of death and gross necropsy (Dose level 5000 mg/kg, 12.5 mL/kg)
Animal No. |
Dose amount (mL) |
Date of dosing |
Body weights (g) |
Time of death* |
Gross necropsy findings |
||
Day 0 |
Day 7 |
Final |
|||||
201 |
2.38 |
26 Feb 08 |
190 |
223 |
243 |
Day 14 |
No observable abnormalities |
202 |
2.34 |
28 Feb 08 |
187 |
218 |
231 |
Day 14 |
No observable abnormalities |
203 |
2.32 |
28 Feb 08 |
186 |
220 |
232 |
Day 14 |
No observable abnormalities |
* Day of dosing is Day 0; Day 14 is terminal sacrifice
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The acute oral toxicity study is considered reliable and acceptable according to the requirements for REACH.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 6 February - 3 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- - Lot No. of test material: 07-170-FIL-2/3
- Appearance: White powder
- Expiration date: May 2010
- Purity: 98.4%
- Storage condition of test material: Room temperature - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Texas Animal Specialties, Humble, TX
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approx. 9 weeks old
- Weight at study initiation: Males 239 - 304 g; Females 165 - 219 g
- Fasting period before study: No
- Housing: Suspended, wire bottom, stainless steel cage; 1 animal per cage
- Diet: PMI Feeds Inc. Formulab #5008 available ad libitum
- Water: Municipal water supply available ad libitum from automatic water system
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 12 air changes/ hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 27 February 2008 To: 13 March 2008 - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test material was applied to the dorsal surface of the trunk in a thin uniform layer.
- % coverage: Not less than 10% of the total body surface area was clipped
- Type of wrap if used: The area of application was covered with a 5 x 10 cm surgical gauze patch and secured with non-irritating adhesive tape. The trunk of each animal was then wrapped with vet wrap which was secured in place with non-irritating adhesive tape to prevent possible ingestion of the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test material as possible.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The dose amount was 1.21 - 1.54 g in males and 0.823 - 1.01 g in females.
- Concentration (if solution): An individual dose was calculated for each animal based on its Day 0 bodyweight just before exposure.
- Constant volume or concentration used: no
- For solids, paste formed: The test material was moistened with water.
VEHICLE
- Concentration (if solution): Each dose was moistened with a sufficient amount of deionised water at a concentration of 1.0 mL/g of test substance. - Duration of exposure:
- 24 hours exposure to test material
- Doses:
- 5050 mg/kg
- No. of animals per sex per dose:
- 5 animals/ sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations for mortality and clinical/ behavioural signs of toxicity: 2-3 times on the day of exposure (Day 0) and at least once daily thereafter for 14 days
- Frequency of weighing: Individual body weights were recorded just prior to dosing and on days 7 and 14.
- Frequency of dermal irritation observations: approximately 60 minutes after removal of wrappings and on Days 4, 7, 11 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 050 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- There was no mortality during the study.
- Clinical signs:
- other: All animals appeared normal for the duration of the study. Irritation included very slight erythema in one animal on Day 1.
- Gross pathology:
- The gross necropsy conducted at termination of the study revealed no observable abnormalities.
- Other findings:
- - Actual temperature: 20 - 24°C
- Actual relative humidity: 27 - 90% (Humidity was outside of the protocol range but did not affect the study outcome) - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of the test substance, Formononetin, is estimated to be greater than 5050 mg/kg in males and females.
Reference
Table 1: Body weights, time of death and gross necropsy (Dose level 5050 mg/kg)
Animal No. |
Dose amount (g) |
Body weights (g) |
Time of death* |
Gross necropsy findings |
||
Day 0 |
Day 7 |
Final |
||||
251-M |
1.21 |
239 |
269 |
284 |
Day 14 |
No observable abnormalities |
252-M |
1.42 |
282 |
311 |
337 |
Day 14 |
No observable abnormalities |
253-M |
1.45 |
288 |
318 |
342 |
Day 14 |
No observable abnormalities |
254-M |
1.41 |
279 |
315 |
346 |
Day 14 |
No observable abnormalities |
255-M |
1.54 |
304 |
336 |
349 |
Day 14 |
No observable abnormalities |
256-F |
0.944 |
187 |
198 |
207 |
Day 14 |
No observable abnormalities |
257-F |
0.914 |
181 |
196 |
212 |
Day 14 |
No observable abnormalities |
258-F |
1.01 |
200 |
215 |
227 |
Day 14 |
No observable abnormalities |
259-F |
1.01 |
219 |
237 |
249 |
Day 14 |
No observable abnormalities |
260-F |
0.823 |
165 |
177 |
189 |
Day 14 |
No observable abnormalities |
* Day of dosing is Day 0; Day 14 is terminal sacrifice
M – Male
F – Female
Note: Animal 259 dose amount should have been 1.11 g
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 050 mg/kg bw
- Quality of whole database:
- The acute dermal toxicity study is considered reliable and acceptable according to the requirements for REACH. The endpoint is not required for Annex VII registrations but an acute dermal toxicity study had been performed in 2008 for other regulations and has therefore been submitted as supporting information under REACH.
Additional information
Justification for classification or non-classification
Oral: The oral LD50 for rats was >5000 mg/kg bw in a study performed in accordance with OECD Guideline 425. Therefore, the substance does not require classification according to the criteria described in Regulation (EC) No. 1272/2008.
Dermal: The dermal LD50 for rats was >5050 mg/kg bw in a study performed in accordance with OECD Guideline 402. Therefore, the substance does not require classification according to the criteria described in Regulation (EC) No. 1272/2008.
Inhalation: Data are not available and are not a requirement for Annex VII REACH registrations.
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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