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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Food Flavorings and Compounds of Related Structure I. Acute Oral Toxicity
Author:
P. M. JENNER, E C. HAGAN, JEAN M. TAYLOR, E. L. COOK and O. G. FITZHUGH
Year:
1964
Bibliographic source:
Fd Cosmet. Tex/col Vol. 2 pp. 327-343. Pergamon Press 1964.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
The purpose of this study was to evaluate the toxicity of Allyl butyrate in relation to their use as food additives in Osborne-Mendel rats.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl butyrate
EC Number:
218-129-8
EC Name:
Allyl butyrate
Cas Number:
2051-78-7
Molecular formula:
C7H12O2
IUPAC Name:
prop-2-en-1-yl butanoate
Test material form:
liquid
Details on test material:
- Name of test material (IUPAC name): 2-Propen-1-yl butanoate
- Common name: Allyl butyrate
- Molecular formula: C7H12O2
- Molecular weight: 128.17 g/mol
- Smiles notation: C(OCC=C)(CCC)=O
- InChl: 1S/C7H12O2/c1-3-5-7(8)9-6-4-2/h4H,2-3,5-6H2,1H3
- Substance type: Organic
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material (IUPAC name): 2-Propen-1-yl butanoate
- Common name: Allyl butyrate
- Molecular formula: C7H12O2
- Molecular weight: 128.17 g/mol
- Smiles notation: C(OCC=C)(CCC)=O
- InChl: 1S/C7H12O2/c1-3-5-7(8)9-6-4-2/h4H,2-3,5-6H2,1H3
- Substance type: Organic

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Housed individually in wire cages.
- Diet (e.g. ad libitum): food ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Details on oral exposure
No data available
Duration of treatment / exposure:
90 mg/kg/day given for 18 week
50 mg/kg/day given for 17 weeks
Frequency of treatment:
Daily
Doses / concentrationsopen allclose all
Dose / conc.:
50 other: mg/kg/day
Dose / conc.:
90 other: mg/kg/day
No. of animals per sex per dose:
50 mg/kg/day 10 male and 10 female
90 mg/kg/day 10 male and 10 female
Control animals:
not specified
Details on study design:
Details on study design
No data available
Positive control:
Not specified

Examinations

Observations and examinations performed and frequency:
Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: No data available.

DETAILED CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: No data available

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available.

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available

OPHTHALMOSCOPIC EXAMINATION: No data available

HAEMATOLOGY: No data available.

CLINICAL CHEMISTRY: No data available

URINALYSIS: No data available

NEUROBEHAVIOURAL EXAMINATION: No data available
Sacrifice and pathology:
Sacrifice and pathology
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Statistics:
No data available.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Clinical signs- Growth retardation was observed in male at dose 90 mg/kg/day.
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Rough and granular surface, firm consistency, nutmeg appearance was observed in liver at 90 mg/kg/day.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
At 90 mg/kg/day slight to moderate bile duct proliferation and fibrosis with pseudolobule formation .Necrosis with polymorph nuclear infiltration and swollen, foamy liver in 2-8 rats was observed.
At 50 mg/kg/day slight to marked prebrochial lymphocyte infilteration was examined in treated group compare to controls. No effect was observed in liver at 50 mg/kg/day
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
50 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
histopathology: non-neoplastic
Remarks on result:
other: No Growth retardation was observed .There was significant microscopic change in lung was observed.

Target system / organ toxicity

Critical effects observed:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was found to be 50 mg/kg for Allyl butyrate in male and female Osborne-Mendel rats for 17 weeks by oral (gavage).
Executive summary:

Repeated toxicity study forAllyl butyratein male and femaleOsborne-Mendel rats was observed when they were exposed in a concentration of 50 and 90 mg/kg for 17 and 18 week respectively by oral (gavage). Rough and granular surface, firm consistency, nutmeg appearance was observed in liver at 90 mg/kg/day. At 90 mg/kg/day slight to moderate bile duct proliferation and fibrosis with pseudolobule formation .Necrosis with polymorph nuclear infiltration and swollen, foamy liver in 2-8 rats was observed. At 50 mg/kg/day slight to marked prebrochial lymphocyte infilteration was examined in treated group compare to controls. No effect was observed in liver at 50 mg/kg/day. As no significant change were observed on the clinical sign and gross pathology of other organ . Therefore NOAEL was found to be 50 mg/kg/day forAllyl butyrate for chronic study.