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EC number: 225-004-1 | CAS number: 4602-84-0
- 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
Acute oral toxicity: The oral LD50 could not be calculated as there was no effect on mortality in the study. Therefore the oral LD50 in rats is considered to be >20 mL/kg, which, based on a density of 0.888, is equivalent to >17760 mg/kg.
Acute inhalation toxicity: This endpoint is waived as adequate data from acute studies via oral and dermal routes are available.
Acute dermal toxicity: The dermal LD50 could not be calculated as there was no effect on mortality in the study. Therefore the dermal LD50 in rats is considered to be >15000 mg/kg.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study not conducted according to regulatory guideline method or GLP, however study is well-designed and well-reported.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", by the Staff of the Division of Pharmacology, FDA
- Version / remarks:
- 1959
- Deviations:
- no
- Principles of method if other than guideline:
- A single dose of the test material was administered orally to groups of 10 Wistar rats (5 males and 5 females) at doses of 10 mL/kg and 20 mL/kg per group; Animals were observed for clinical signs (motor activity, coordination disturbance, piloerection and diarrhoea) and mortality for 7 days after dosing.
Institute Name IBR
Final Report date 00.11.1976
Results acute oral LD50 (rat) > 20 ml/kg (calc.)
Reliability Rel 2
GLP NO
observed, all symptoms reversible within 3 hours. Rel. 2: According to FDA, 1954, but
not GLP, no batch number and no analytical data on purity, probably technically pure
material was tested; - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:120 to 160 g
- Fasting period before study: 16 hours
- Housing: Individual cages
- Diet (e.g. ad libitum): Laboratory standard diet (Ssniff/Intermast), ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 1 °C
- Humidity (%): 45 - 55 % RH
- Photoperiod (hrs dark / hrs light): 12 hr light photoperiod - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 10mL/kg or 20mL/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Preliminary study:
- The doses were determined in a range-finding study. A higher dose is not used in the determinative test for volume reasons.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed at either dose.
- Clinical signs:
- other: Decreased motor activity, coordination disturbance, piloerection and diarrhoea were observed, however these symptoms were reversible after 3 hours.
- Gross pathology:
- No pathological changes in cranial, thoracic and abdominal cavities observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 in rat is > 20mL/kg.
- Executive summary:
In an acute oral toxicity study, groups of 10 Wistar rats (5 males & 5 females) per group, received doses of 10 and 20 mL test material/kg by gavage and were observed for 7 days thereafter. There were no mortalities or pathologic effects observed. There was decreased motor activity, disturbances of coordination, piloerection and diarrhoea, however all symptoms were reversible within 3 hours. The LD50 was estimated to be > 20 mL/kg. This study is reliable with restrictions (Klimisch 2) as it was conducted according to guideline, however GLP status is unknown.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 17 760 mg/kg bw
- Quality of whole database:
- One key study is available, which is considered to be reliable with restrictions (Klimisch 2) as it was conducted according to guideline, however GLP status is unknown.
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:
- key study
- Study period:
- 07 December 1982 - 23 December 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Non-guideline, non-GLP study, however experimental details and results are well-reported.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Acute dermal toxicity was tested in male and female WISW-strain rats. Applications were made on scarified and intact skin and test animals were observed for 14-days for any signs of reaction and mortality.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: BOR: WISW (substrain SPF TNO)
- Weight at study initiation: 190.0 to 258.0 g for males, 160.0 to 205.0 g for females
- Housing: maximum 5 rats per cage
- Diet (e.g. ad libitum): Pellets with added vitamins
- Water (e.g. ad libitum): Aqua fontana fit for human consumption, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 45 to 55%
- Photoperiod (hrs dark / hrs light): 12 hour photoperiod with fluorescent lighting (120 Lux)
IN-LIFE DATES: From: 7/12/1982 To: 23/12/1982 - Type of coverage:
- other: Scarified and intact skin
- Vehicle:
- other: white Vaseline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Clipped area (8 x 5 cm) on the back of each test animal; one group was abraded with a clean clipper blade to penetrate the horny layer of the epidermis without causing bleeding, while the other group was left intact.
- Type of wrap if used: Dose secured for 24 hours with gauze pads and plastic material
REMOVAL OF TEST SUBSTANCE
- Washing: Substance removed with wet disposable gauze
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2.40 to 3.88 g
- Concentration: 10%
- Constant volume or concentration used: Constant concentration, the application sample was weighed per animal
- For solids, paste formed: yes - Duration of exposure:
- 24h
- Doses:
- 10%
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical-toxicological signs (modified Irvin-Screening) recorded at 2, 4, 24, 48 and 72 hrs and 7 and 14 days after application; body weight recorded at the start and end of experiment on the surviving animals.
- Necropsy of survivors performed: yes, immediately after all mortalities and upon study completion for the survivors
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Skin alterations (modified Draize-Scheme) recorded at 24 hours and 3, 7 and 14 days after application - Preliminary study:
- Pairs of female rats were scarified and administered with 5 and 15 g/kg bodyweight.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortalities were observed
- Clinical signs:
- other: The sample did not induce any clinical-toxicological symptoms and no skin alternations were observed.
- Gross pathology:
- No gross pathological findings were recorded.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of 10% farnesol in Vaseline was determined to be > 15 g/kg bodyweight for rat.
- Executive summary:
The acute dermal toxicity of 10% farnesol in Vaseline was tested in male and female WISW rats. A single dose of 15 g/kg bodyweight was applied on scarified and intact skin of the test animals and secured for 24 hours. Mortality, clinical signs of toxicity, changes in bodyweight, skin alterations and gross pathology were observed for 14 days following application. No mortalities were observed and the dermal LD50 was determined to be > 15 g/kg bodyweight. This study is reliable with restrictions (Klimisch 2) as it was well-designed and well-reported, however was not performed according to any specific guideline or to GLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 15 000 mg/kg bw
- Quality of whole database:
- One key study is available, which is considered to be reliable with restrictions (Klimisch 2) as no guideline or GLP compliance was reported, however the experimental design and reporting were adequate.
Additional information
Acute oral toxicity: In the key acute oral toxicity study, groups of 10 Wistar rats (5 males & 5 females) per group, received doses of 10 and 20 mL test material/kg by gavage and were observed for 7 days thereafter (1976). There were no mortalities or pathologic effects observed. There was decreased motor activity, disturbances of coordination, piloerection and diarrhoea, however all symptoms were reversible within 3 hours. The LD50 was estimated to be > 20 mL/kg. With relative density measured at 0.888 g/cm3, the oral LD50 was estimated to be > 17.76 g/kg. This study is reliable with restrictions (Klimisch 2) as it was conducted according to guideline, however GLP status is unknown.
Acute inhalation toxicity: This endpoint is waived as adequate data from acute studies via oral and dermal routes are available. Exposure to humans via inhalation is not likely given the low vapour pressure of the substance.
Acute dermal toxicity: In the key acute dermal toxicity study, a single dose of 15 g/kg bodyweight (10% farnesol in vaseline) was applied on scarified and intact skin of male and female WISW rats and secured for 24 hours (1983). Mortality, clinical signs of toxicity, changes in bodyweight, skin alterations and gross pathology were observed for 14 days following application. No mortalities were observed and the dermal LD50 was determined to be > 15 g/kg bodyweight. This study is reliable with restrictions (Klimisch 2) as it was well-designed and well-reported, however was not performed according to any specific guideline or to GLP.
Justification for classification or non-classification
The two key studies for the acute toxicity endpoint were performed in rats by either the oral or dermal routes of administration. Both studies were considered to be of robust design and well reported and assigned a Klimisch score of 2 (reliable with restrictions). As the acute oral and dermal studies resulted in predicted LD50 levels in excess of the 2000 mg/kg limit dose, it was concluded that farnesol is not classified for acute toxicity according to the CLP Regulation (EC) No 1272/2008.
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