Registration Dossier
Registration Dossier
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EC number: 203-377-1 | CAS number: 106-24-1
Repeated dose toxicity: oral
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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
