Registration Dossier
Registration Dossier
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EC number: 203-105-1 | CAS number: 103-37-7
Repeated dose toxicity: oral
Administrative data
- 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 peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance Material review for the test chemical
- Author:
- McGinty et.al
- Year:
- 2 012
- Bibliographic source:
- Food and Chemical Toxicology, 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Subchronic oral toxicity test of the test chemical was conducted on rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Benzyl butyrate
- EC Number:
- 203-105-1
- EC Name:
- Benzyl butyrate
- Cas Number:
- 103-37-7
- Molecular formula:
- C11H14O2
- IUPAC Name:
- benzyl butanoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzyl butyrate
- IUPAC NAME: Butanoic acid, phenylmethyl ester
- Molecular formula : C11H14O2
- Molecular weight : 178.23 g/mole
- Smiles notation : c1(COC(CCC)=O)ccccc1
- InChl : 1S/C11H14O2/c1-2-6-11(12)13-9-10-7-4-3-5-8-10/h3-5,7-8H,2,6,9H2,1H3
- Substance type: Organic
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- No data available
Doses / concentrations
- Remarks:
- 2229.9 (males) and 1815.9 mg/Kg (females) - Total intake
- No. of animals per sex per dose:
- 12/sex
- Control animals:
- not specified
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes, Physical appearance and behaviour was observed
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data available
BODY WEIGHT: No data
- Time schedule for examinations: No data available
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- 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 available
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations:
- Dose groups that were examined: No data available
HAEMATOLOGY: No data
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data available
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood:
- Animals fasted: No data
- How many animals: No data available
- Parameters checked in table [No.?] were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: at the end of 12 weeks
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, liver and kidney weights were taken
HISTOPATHOLOGY: No - Other examinations:
- No data
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No signs of clinical toxicity were observed.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- No abnormalities were observed
- 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:
- no effects observed
- Description (incidence and severity):
- No abnormalities were observed
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 2 229.9 mg/kg diet
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Physical appearance, behavior, food utilization, Liver and kidney weights
- Dose descriptor:
- NOAEL
- Effect level:
- 1 815.9 mg/kg diet
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Physical appearance, behavior, food utilization, Liver and kidney weights
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The no observed adverse effect level (NOAEL) is considered to be 2229.9 mg/Kg (males) and 1815.9 mg/Kg (females) when rats were exposed to the test chemical for 12 weeks.
- Executive summary:
Repeated dose oral toxicity study was performed using rats to determine the toxic nature of the test chemical. The test chemical was incorporated into the diet of 24 (12/sex) rats for 12 weeks as part of a blend with five other aromatic esters. The total intake was 2229.9 (males) and 1815.9 mg (females); The test chemical alone was not measured. Observations were made on physical appearance, behavior, and food utilization. Urine samples were collected at the end of the 12 weeks. Liver and kidney weights were obtained. The no observed adverse effect level (NOAEL) is considered to be 2229.9 mg/Kg (males) and 1815.9 mg/Kg (females) when rats were exposed to the test chemical for 12 weeks.
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