Phenethyl propionate

Acute Toxicity: oral

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from peer-reviewed journal

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Fragrance material review on phenethyl propionate

Author:

D. McGinty, D. Vitale, C.S. Letizia, A.M. Api

Year:

2012

Bibliographic source:

Food and Chemical Toxicology 50 (2012) S430–S434

Reference 2

Reference Type:

publication

Title:

A toxicological and dermatological assessment of aryl alkyl alcohol simple acid ester derivatives when used as fragrance ingredients

Author:

D. Belsito , D. Bickers , M. Bruze , P. Calow , M.L. Dagli , A.D. Fryer ,H. Greim , Y. Miyachi , J.H. Saurat , I.G. Sipes

Year:

2012

Bibliographic source:

Food and Chemical Toxicology, 50 (2012) S269–S313

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: refer below

Principles of method if other than guideline:

The acute toxicity study was conducted to evaluate the toxic effects of administration of phenethyl propionate (CAS No. 122-70-3) in rat by the oral route.

GLP compliance:

not specified

Test type:

other: No data available

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl propionate

EC Number:

204-567-7

EC Name:

Phenethyl propionate

Cas Number:

122-70-3

Molecular formula:

C11H14O2

IUPAC Name:

2-phenylethyl propanoate

Details on test material:

SMILES:CCC(=O)OCCc1ccccc1

Specific details on test material used for the study:

- Name of test material: Phenethyl propionate
- Molecular formula: C11H14O2
- Molecular weight: 178.2296 g/mol
- Smiles notation: c1(CCOC(=O)CC)ccccc1
- InChl: 1S/C11H14O2/c1-2-11(12)13-9-8-10-6-4-3-5-7-10/h3-7H,2,8-9H2,1H3
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data available
- Females (if applicable) nulliparous and non-pregnant: 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: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To:No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data available
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): No data available

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available

Doses:

2220, 3330, 5000 or 7500 mg/kg

No. of animals per sex per dose:

2220 mg/kg : 10 rats
3330 mg/kg : 10 rats
5000 mg/kg : 10 rats
7500 mg/kg : 10 rats

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and mortality

Statistics:

No data available

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

95% CL:

2 630 - 5 370

Mortality:

The incidence of mortality was 0/10, 5/10, 6/10 and 10/10 from low to high dose. All deaths occurred by day two.

Clinical signs:

other: Clinical signs of toxicity at 3.33 g/kg and above were depression, slow respiration and negative righting reflex.

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

other: not classified based on CLP criteria

Conclusions:

The acute oral median lethal dose (LD50) of phenethyl propionate in rat was observed to be 4000.0 mg/kg b.wt with 95% confidence limit of 2630 – 5370 mg/kg.

Executive summary:

The acute toxicity study was conducted to evaluate the toxic effects of administration of phenethyl propionate (CAS No. 122-70-3) in rat by the oral route. The test material was administered by oral gavage to rats (10/group) at doses of 2220, 3330, 5000 or 7500 mg/kg followed by a 14 day observation period. The incidence of mortality was 0/10, 5/10, 6/10 and 10/10 from low to high dose. All deaths occurred by day two. Clinical signs of toxicity at 3330 mg/kg and above were depression, slow respiration and negative righting reflex. The acute oral median lethal dose (LD50) of phenethyl propionate in rat was observed to be 4000.0 mg/kg b.wt with 95% confidence limit of 2630 – 5370 mg/kg. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that of phenethyl propionate (CAS No. 122-70-3) can be classify under non toxic category at the tested dose level of 4000.0 mg/kg body weight.