Allyl propionate

Endpoint summary

Description of key information

Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of Allyl propionate upon repeated exposure for 13 weeks. The study was performed using rats. The test chemical was mixed with feed at dose levels of 18 mg/Kg bw and fed to rats for 13 weeks. During the study, the animals were observed for hepatotoxicity. No signs of hepatic toxicity were noted at the mentioned dose level. Based on the data available, the No Observed Adverse Effect Level (NOAEL) for Allyl propionate is considered to be 18 mg/Kg bw/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

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:

data from handbook or collection of data

Justification for type of information:

Data is from WHO report

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Subchronic repeated dose oral toxicity study was performed to determine the oral toxic nature of Allyl propionate upon repeated exposure for 13 weeks using rats

GLP compliance:

not specified

Limit test:

no

Specific details on test material used for the study:

- Name of test material: Allyl propionate
- Molecular formula: C6H10O2
- Molecular weight: 114.143 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): No data

Species:

rat

Strain:

not specified

Details on species / strain selection:

No data

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Route of administration:

oral: feed

Details on route of administration:

No data

Vehicle:

other: Feed

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with feed at dose level of 18 mg/Kg bw/day

DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data

VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 18 mg/Kg bw/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No data

Duration of treatment / exposure:

13 weeks

Frequency of treatment:

No data

Remarks:

18 mg/Kg bw/day

No. of animals per sex per dose:

No data

Control animals:

not specified

Details on study design:

No data

Positive control:

No data

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data

DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data

BODY WEIGHT: No data
- Time schedule for examinations: No data

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

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

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data

HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data - Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

OTHER: The animals were observed for hepatotoxicity

Sacrifice and pathology:

No data

Other examinations:

No data

Statistics:

No data

Clinical signs:

not specified

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:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

no effects observed

Description (incidence and severity):

Clinical signs and mortality: No data

Body weight and weight gain: No data

Food consumption and compound intake: No data

Food efficiency: No data

Water consumption and compound intake: No data

Opthalmoscopic examination: No data

Haematolog: No data

Clinical chemistry: No data

Urinanalysis: No data

Neurobehaviour: No data

Organ weights: No data

Gross pathology: No data

Histopathology: No data

Details on results:

No data

Dose descriptor:

NOAEL

Effect level:

18 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: No hepatotoxicity was noted at the mentioned dose level

Critical effects observed:

no

Organ:

liver

Conclusions:

The No Observed Adverse Effect Level (NOAEL) for Allyl propionate is considered to be 18 mg/Kg bw/day.

Executive summary:

Subchronic repeated dose oral toxicity study was performed to determine the oral toxic nature of Allyl propionate upon repeated exposure for 13 weeks. The study was performed using rats. The test chemical was mixed with feed at dose levels of 18 mg/Kg bw and fed to rats for 13 weeks. During the study, the animals were observed for hepatotoxicity. No signs of hepatic toxicity were noted at the mentioned dose level. Based on the data available, the No Observed Adverse Effect Level (NOAEL) for Allyl propionate is considered to be 18 mg/Kg bw/day.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

18 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Quality of whole database:

Data is from WHO Technical series

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Repeated dose toxicity: Oral

Data available for the target chemical was reviewed to determine the toxic nature of Allyl propionate uon repeated exposure by oral route. The study is as mentioned below:

Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of Allyl propionate upon repeated exposure for 13 weeks. The study was performed using rats. The test chemical was mixed with feed at dose levels of 18 mg/Kg bw and fed to rats for 13 weeks. During the study, the animals were observed for hepatotoxicity. No signs of hepatic toxicity were noted at the mentioned dose level. Based on the data available, the No Observed Adverse Effect Level (NOAEL) for Allyl propionate is considered to be 18 mg/Kg bw/day.

In another study ( Flavor and Extract Manufacturers' Association, 1985) for the target chemical, subchronic repeated dose oral toxicity study was performed to determine the oral toxic nature of Allyl propionate upon repeated exposure for 90 days. The study was performed using male and female Charles River CD rats. The test chemical was mixed with the diet 10.1% on gum arabic to give an average daily intake of 15.54 (males) and 18.10 (females) mg/kg. The animals were observed for body weight and food consumption changes, hematological, blood chemical and urine analysis. The animals were autopsied and gross and histopathology was performed. Weekly measurement of body weights and food intake revealed a significant decrease in body weights in both sexes.Hematological examination, blood chemical determinations and urinanalysis conducted at weeks 6 and 12 revealed decreased hemoglobin levels in males only. Organ weights at autopsy were normal. Gross and histopathological examination revealed no dose-related abnormalities. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for Allyl propionate is considered to be 15.54 mg/Kg for males and 18.10

mg/Kg for females.

Study for 50 -60% structurally similar read across chemical mentioned in Food and Agriculture Organization of the United Nations and WHO (1968) was also reviewed. In a repeated oral toxicity study, male and female rats were administered 14.4 mg/kg bw of Ethyl butyrate (RA CAS no 105 -54 -4) in diet for 12 weeks. Based on the results, no adverse effects were noted in the animals. Therefore, the No Observed Adverse Effect Level (NOAEL) was considered to be 14.4 mg/kg bw when male and female rats were exposed to Ethyl butyrate for 12 weeks by diet.

Based on the data available for the target chemical, Allyl propionate does not exhibit toxic nature upon repeated exposure by oral route. Hence the test chemical is not likely to classfy as toxicant upon repeated exposure by oral route.

Justification for classification or non-classification

Based on the data available for the target chemical, Allyl propionate (CAS no 2408 -20 -0 ) does not exhibit toxic nature upon repeated exposure by oral route. Hence the test chemical is not likely to classfy as toxicant upon repeated exposure by oral route.