Registration Dossier

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 publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Food flavorings and compounds of related structure I. Acute Oral Toxicity
Author:
Jenner PM et al.
Year:
1964
Bibliographic source:
Food Cosmet. Toxicol. 2, 327-343
Reference Type:
secondary source
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute oral toxicity study
GLP compliance:
no
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): geranyl acetate
no further data given

Test animals

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

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
- Examinations performed: clinical signs, mortality
no further data given

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
6 330 mg/kg bw
95% CL:
5 450 - 7 340
Mortality:
Times of death: 4 - 72 h
no further data given
Clinical signs:
Depression, coma

Applicant's summary and conclusion