Registration Dossier
Registration Dossier
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EC number: 203-377-1 | CAS number: 106-24-1
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Subchronic inhalation studies of complex fragrance mixtures in rats and hamsters.
- Author:
- Fukayama MY, Easterday OD, Serafino PA, Renskers KJ, North-Root H and Schrankel KR
- Year:
- 1 999
- Bibliographic source:
- Toxicology Letters 111(1-2): 175-187
Materials and methods
- Principles of method if other than guideline:
- 6 and 13 week inhalation study with fragrance mixtures
Test material
- Reference substance name:
- Geraniol
- EC Number:
- 203-377-1
- EC Name:
- Geraniol
- Cas Number:
- 106-24-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Fragrance mixtures (FM) B, E, F
- Composition of test material, percentage of components:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD and Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Wilmington (CD rats), Taconic Farms, Germantown, NY (SD rats)
- Age at study initiation: young
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: ethanol
- Remarks on MMAD:
- MMAD / GSD: 0.5 µm in FM E
4.3 µm in FM F - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Method of holding animals in test chamber: individually and placed in custom-made stainless steel inhalation chambers fitted with Plexiglas doors in the front and back.
- Source and rate of air: Compressed air, 6 to 34 cubic feet per minute
- Method of conditioning air: oil free and dried to 2°C
- System of generating particulates/aerosols: Laskin-type nebulizer
- Temperature, humidity, pressure in air chamber:
- Air flow rate: 1.6 - 4 l/min
- Method of particle size determination: Andersen Cascade Impactor
- Treatment of exhaust air: filtered through a comination of pre- and absulute filters, followed by a charcoal filter
TEST ATMOSPHERE
- Brief description of analytical method used: exposure concentration was established gravimetrically
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 6 or 13 weeks, 4 h a day, 5 days a week
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
5.7 µg/m^3 in FM B
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
37.8 µg/m^3 in FM F
Basis:
- No. of animals per sex per dose:
- 20 for FM B
12 for FM E
24 for Fm F - Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on the day or two following the last exposure
- Anaesthetic used for blood collection: Yes (sodium pentobarbital)
- Animals fasted: Yes, 16 h
- How many animals: all
- Parameters examined: red blood cell count, total and differential white blood cell counts, mean corpuscular volume, hemoglobin concentration and hematocrit.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on the day or two following the last exposure
- Animals fasted: Yes, 16 h
- How many animals: all
- Parameters examined: fasting glucose, urea nitrogen, glutamicoxalacetic transaminase, glutamic-pyruvic transaminase and alkaline phosphatase - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes: adrenal glands (both),brain, esophagus, eye, heart, muscle with sciatic nerve, kidneys, colon, trachea, lungs, hilar lymph
node, liver, pancreas, spleen, stomach, skin, duodenum, spinal cord, sternum, thyroid, urinary bladder, uterus, ovaries or testes, and any lesions or tissue masses and their regional lymph nodes
HISTOPATHOLOGY: Yes: trachea, lungs, adrenals, brain, esophagus, heart, kidneys, liver, panereas, spleen, sternum and uterus. - Statistics:
- Student's t-test
Results and discussion
Results of examinations
- Details on results:
- No abnormalities in any parameter due to fragrance mixtures including geraniol compared to control group was observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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