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EC number: 203-377-1 | CAS number: 106-24-1
Toxicological information
Repeated dose toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented publication
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Food Flavourings and Compounds of Related Structure. II. Subacute and Chronic Toxicity
- Author:
- Hagan EC, Hansen WH, Fitzhugh OG, Jenner PM, Jones WI, Taylor JM, Long EL, Nelson AA, Brouwer JB
- Year:
- 1 967
- Bibliographic source:
- Fd. Cosmet. Toxicol. 5: 141
- Reference Type:
- secondary source
- Title:
- Die Situation in der gesundheitlichen Beurteilung der Aromatisierungsmittel für Lebensmittel
- Author:
- Bär F and Griepentrog F
- Year:
- 1 967
- Bibliographic source:
- Med. Ernaer., Vol. 8, pp244-251
- Reference Type:
- secondary source
- Title:
- Fragrance Raw Materials Monographs
- Author:
- Opdyke DLJ
- Year:
- 1 974
- Bibliographic source:
- Food and Cosmetics Toxicology, Vol. 12: 881-882
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- subchronic to chronic feeding study
- GLP compliance:
- no
- Limit test:
- no
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): Geraniol Extra
- Isomers composition:
3,7-Dimethyl-2,6-octadienol
and 3,7-Dimethyl-1,6-octadienol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: individually
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 112 days at 10000 ppm; 189-196 days at 1000 ppm
- Frequency of treatment:
- continuously in diet
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 or 10000 ppm (ca. 55 or 550 mg/kg/day)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at termination of study
- Parameters checked: white cell counts, red cell counts, hemoglobin and hematocrits - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes; liver, kidneys, spleen, heart, testes, abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle
- Organ weights of liver, kidneys, spleen, heart and testes were recorded
- Detailed microscopic examinations in the subacute study were done on 6 or 8 animals evenly divided by sex, in the high dose group and control group, if multiple doses were tested.
- If changes attributable to the test compound were found in the high dose group, additional animals on lower dosage levels were examined.
- For animals from the long-term study more extensive histopathological study was done.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Haematological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- > 10 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed at highest tested dose level
- Dose descriptor:
- NOEL
- Effect level:
- > 550 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed at highest tested dose level
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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