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EC number: 203-517-1 | CAS number: 107-74-4
- 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
The aim of the study was to obtain information on the toxicity of Hydroxycitronellol in rats when given by oral administration via gavage daily for 28 days. The rats were treated with 100, 300 or 1000 mg Hydroxycitronellol/kg b.w./day. The control animals received the vehicle (Labrasol). No deaths occurred during the course of the study. All animals survived until scheduled necropsy. No test item-related changes were observed in behaviour or external appearance, during detailed clinical observations or for any of the parameter of the neurological screening, the body weight, body weight gain and body weight at autopsy, the food and drinking water consumption, the haematological, coagulation and clinical chemistry parameters, the eyes or optic region, the auditory acuity, the relative and absolute organ weights and at macroscopic inspection at necropsy and at histopathological examination at any of the tested dose levels. The faeces of all animals were of a normal consistency throughout the study. In conclusion, under the present test conditions of this study, the NOAEL (No-Observed-Adverse-Effect-Level) is above 1000 mg Hydroxycitronellol/kg b.w./day when given by oral administration as a Labrasol formulation via gavage daily for 28 days.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017 to 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 2008-10
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Specific details on test material used for the study:
- Designation: Hydroxycitronellol
Batch no.: BM 7/17
Lot no.: 239/17
Characteristics: Clear colourless, viscous liquid; floral, green, sweet odour
Expiry date: 2019-06-14
Content: 99.7% area GC - Species:
- rat
- Strain:
- other: CD®
- Details on species / strain selection:
- The rat was selected because of its proven suitability in toxicology studies and to comply with regulatory requirements for testing in a rodent animal species.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- CD® rats supplied by Charles River Laboratories Germany GmbH were used in this study. The body weight range did not exceed 10% of the mean weight for each sex at the time of selection. An initial health check was performed upon delivery of the animals.
Species / Strain / Stock: Rat / CD® / Crl:CD(SD)
Breeder: Charles River Laboratories Germany GmbH, Sulzfeld, Germany
Body weight: 205 - 366 g
Age: 59 days
Adaptation period: 5 days
Diet: ad libitum
Water: ad libitum
The animals were kept singly in MAKROLON cages (type III plus).
Room temperature: 22°C ± 3°C
Relative humidity: 55% ± 10%
The rooms were lit and darkened for periods of 12 hours each. - Route of administration:
- oral: gavage
- Vehicle:
- other: Labrasol
- Details on oral exposure:
- Administration volume: 2 mL/kg b.w./day
The administration formulations were freshly prepared every day by diluting the test item in the vehicle to the appropriate concentrations. Test item formulations were prepared with concentrations of 50, 150 or 500 mg Hydroxycitronellol/mL Labrasol.
The test item was administered orally at a constant volume per kilogram body weight once daily for 28 days. The dose of the test item was adjusted to each animal's body weight daily. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The results indicate that all test item formulations were correctly prepared by LPT, and were stable for at least 24 hours. The measured concentrations ranged from 92.0% to 101.5% in the test item formulation samples.
- Duration of treatment / exposure:
- 28 consecutive days
- Frequency of treatment:
- Once daily for 28 consecutive days
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5 animals/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The dose levels for this study were based on the results of a 7-day dose-range finding study (LPT Study No. 35127). In this study, the animals were treated orally with 100, 300 or 1000 mg Hydroxycitronellol/kg b.w. daily for 7 days. The control group was treated with the vehicle (Labrasol) in the same way. None of the animals died prematurely during the course of the study. All male and female rats treated orally with 100, 300, or 1000 mg Hydroxycitronellol/kg b.w. daily for 7 days revealed moderate salivation starting up to 5 minutes p.a. lasting 5 to 20 minutes from test days 4 onwards. The body weight and the food and drinking water consumption were not test item-relatedly influenced. At necropsy on test day 8, no macroscopic changes were observed.
- Observations and examinations performed and frequency:
- Clinical signs: daily
Neurological screening: at the end of the treatment period
Mortality: daily
Body weight: at group allocation (test day -5), on test day 1 (before first administration), and daily during the treatment period for dose adjustment
Food consumption: on a weekly basis throughout the experimental period
Water consumption: daily
Laboratory examinations (haematology, clinical chemistry): Blood samples were collected from all animals at the end of the treatment period on test day 29
Ophthalmological and auditory examinations: Examinations were performed predose and at the end of the treatment period (test day 25) - Sacrifice and pathology:
- On test day 29 (approx. 24 hours after the last administration), the animals were euthanized and inspected macroscopically. The histopathological examination included all relevant organs of the control and high dose group.
- Statistics:
- Standard statistical methods were used.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- food efficiency
- gross pathology
- haematology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- water consumption and compound intake
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Critical effects observed:
- no
- Conclusions:
- Under the present test conditions of this study, the NOAEL is above 1000 mg Hydroxycitronellol/kg b.w./day when given by oral administration as a Labrasol formulation via gavage daily for 28 days.
- Executive summary:
The aim of the study was to obtain information on the toxicity of Hydroxycitronellol in rats when given by oral administration via gavage daily for 28 days. The rats were treated with 100, 300 or 1000 mg Hydroxycitronellol/kg b.w./day. The control animals received the vehicle (Labrasol). No deaths occurred during the course of the study. All animals survived until scheduled necropsy. No test item-related changes were observed in behaviour or external appearance, during detailed clinical observations or for any of the parameter of the neurological screening, the body weight, body weight gain and body weight at autopsy, the food and drinking water consumption, the haematological, coagulation and clinical chemistry parameters, the eyes or optic region, the auditory acuity, the relative and absolute organ weights and at macroscopic inspection at necropsy and at histopathological examination at any of the tested dose levels. The faeces of all animals were of a normal consistency throughout the study. In conclusion, under the present test conditions of this study, the NOAEL (No-Observed-Adverse-Effect-Level) is above 1000 mg Hydroxycitronellol/kg b.w./day when given by oral administration as a Labrasol formulation via gavage daily for 28 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The aim of the study was to obtain information on the toxicity of Hydroxycitronellol in rats when given by oral administration via gavage daily for 28 days. The rats were treated with 100, 300 or 1000 mg Hydroxycitronellol/kg b.w./day. The control animals received the vehicle (Labrasol). No deaths occurred during the course of the study. All animals survived until scheduled necropsy. No test item-related changes were observed in behaviour or external appearance, during detailed clinical observations or for any of the parameter of the neurological screening, the body weight, body weight gain and body weight at autopsy, the food and drinking water consumption, the haematological, coagulation and clinical chemistry parameters, the eyes or optic region, the auditory acuity, the relative and absolute organ weights and at macroscopic inspection at necropsy and at histopathological examination at any of the tested dose levels. The faeces of all animals were of a normal consistency throughout the study. In conclusion, under the present test conditions of this study, the NOAEL (No-Observed-Adverse-Effect-Level) is above 1000 mg Hydroxycitronellol/kg b.w./day when given by oral administration as a Labrasol formulation via gavage daily for 28 days.
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