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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP, pre-OECD TG study with sufficient detail in documentation, but volatilisation of test substance from food was not considered

Data source

Reference
Reference Type:
publication
Title:
Food flavorings 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 AM and Brouwer JB
Year:
1967
Bibliographic source:
Food and Cosmetics Toxicology, 5(2), 141-157

Materials and methods

Principles of method if other than guideline:
The study was conducted prior to the publication of OECD TGs. Rats received the test substance via for a period of 52 weeks.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl hexanoate
EC Number:
204-642-4
EC Name:
Allyl hexanoate
Cas Number:
123-68-2
Molecular formula:
C9H16O2
IUPAC Name:
allyl hexanoate
Details on test material:
Name: Allyl caproate (allyl hexanoate)
Purity: commercial product
No further details provided

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: not reported
- Age at study initiation: weanling
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: individually in wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reporte

ENVIRONMENTAL CONDITIONS
- not reported

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DIET PREPARATION
- Rate of preparation of diet (frequency): fresh diets were prepared weekly
- Mixing appropriate amounts with (Type of food): not reported
- Storage temperature of food: not reported
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
52 weeks
Frequency of treatment:
Continuously (animals had free access to food)
Doses / concentrations
Remarks:
Doses / Concentrations:
2500 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
5 males and 5 females
Control animals:
yes, plain diet
Details on study design:
- Dose selection rationale: not reported
Positive control:
No

Examinations

Observations and examinations performed and frequency:
Body weight, food intake and general conditions: every week
Haematology (white cell count, red cell count, haemoglobins, haematocrits): after 3, 6 12 months
Gross pathology: at termination of study
Histopathology: at termination of study
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Other examinations:
Not reported
Statistics:
Not reported

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
No adverse effects were observed/reported.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
> 2 500 mg/kg diet
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects observed/reported
Dose descriptor:
NOAEL
Effect level:
> 214 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: based on 30 g/day food consumption and 350 g/rat body weight

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Oral repeated exposure of rats to allyl hexanoate in food at a concentration of 2500 ppm (mg/kg food) over a period of one year had no adverse effects on male and female rats.
Executive summary:

The repeated oral dose toxicity of allyl hexanoate to male and female Osborne-Mendel rats was studied over a period of 1 year. Five males and five females were fed food containing the test substance at a level of 2500 ppm (mg/kg food). Animals had free access to food over the whole study period. The body weight, food consumption and general condition of animals were recorded regularly. Haematological investigations were performed after 3, 6 and 12 months. At the end of the study all animals were sacrificed. Gross pathology was performed on every rat and organs were weighed. Sections were prepared from relevant organs for histopathological studies, which were performed for a representative fraction of animals in high dose and control groups evenly divided by sex. No adverse effects were observed during or at the end of the study at a dose level of 2500 mg/kg food.