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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute 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 I. Acute Oral Toxicity.
Author:
Jenner PM, Hagan EC, Taylor JM, Cook EL, and Fitzhugh OG
Year:
1964
Bibliographic source:
Fd. Cosm. Toxicol. 2: 327-343
Reference Type:
secondary source
Title:
Fragrance Raw Materials Monographs
Author:
Opdyke DLJ
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology, Vol. 12: 881-882
Reference Type:
secondary source
Title:
Die Situation in der gesundheitlichen Beurteilung der Aromatisierungsmittel fuer Lebensmittel
Author:
Bar VF and Griepentrog F
Year:
1967
Bibliographic source:
Medizin Ernaehr. 8: 244-251
Reference Type:
secondary source
Title:
No information
Author:
Jenner PM, Hagan EC, Taylor JM, Cook EL, and Fitzhugh OG
Year:
2008
Bibliographic source:
RIFM database
Reference Type:
secondary source
Title:
Safety evaluation of certain food additives and contaminants
Author:
INCHEM
Year:
2004
Bibliographic source:
WHO FOOD ADDITIVES SERIES: 52
Reference Type:
secondary source
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
no method specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Geraniol Extra
- Isomers composition: 3,7-Dimethyl-2,6-octadienol
; 3,7-Dimethyl-1,6-octadienol

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALsS
- Fasting period before study: ca. 18 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
no data
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days; when no acute toxic signs were seen, the animals were observed for only one week
-The animals were maintained under close observation for recording of toxic signs and time of death.
Such observation was continued until animals appeared normal and showed weight gain.
Statistics:
LD50 values were computed by the method of Lichfield and Wilcoxon (J. Pharmacol. 96, 99, 1949).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 600 mg/kg bw
95% CL:
2 840 - 4 570
Mortality:
Death time was between 4 hours and 18 hours
Clinical signs:
The described symptoms were depression, coma, and wet fur

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU