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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute oral toxicity of test chemical in rats
Author:
P. M. JENNER et. al.
Year:
1964
Bibliographic source:
Food and Cosmetics Toxicology,1964
Reference Type:
review article or handbook
Title:
Acute oral toxicity of test chemical in rats
Author:
Richard J. Lewis
Year:
1989
Bibliographic source:
Food Additives Handbook , pp 83,1989
Reference Type:
publication
Title:
Acute oral toxicity of test chemical in rats
Author:
D. Belsito et. al.
Year:
2012
Bibliographic source:
Food and Chemical Toxicology ,2012
Reference Type:
other: authoritative database
Title:
Acute oral toxicity of test chemical in rats
Author:
U.S. National Library of Medicine
Year:
2018
Bibliographic source:
Chemidplus Database,U.S. National Library of Medicine,2018
Reference Type:
publication
Title:
Acute oral toxicity of test chemical in rats
Author:
T.B.Adams et. al.
Year:
2005
Bibliographic source:
Food and Chemical Toxicology,2005
Reference Type:
publication
Title:
Acute oral toxicity of test chemical in rats
Author:
D. L. J. Opdyke
Year:
1974
Bibliographic source:
Food and Cosmetics Toxicology, 1974
Reference Type:
review article or handbook
Title:
Acute oral toxicity of test chemical in rats
Author:
Richard J. Lewis
Year:
2012
Bibliographic source:
Sax's Dangerous Properties of Industrial Materials, 12th Edition, 5 Volume Set,2012
Reference Type:
other: secondary source
Title:
Acute oral toxicity of test chemical in rats
Author:
RTECS
Year:
2018
Bibliographic source:
RTECS (registry of toxic effect of chemical substance database), 2018
Reference Type:
publication
Title:
Acute oral toxicity of test chemical in rats
Author:
D. McGinty et. al.
Year:
2012
Bibliographic source:
Food and Chemical Toxicology ,2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute Oral toxicity test was carried out to study the effects of test chemical on rats.
GLP compliance:
not specified
Test type:
other: No data available

Test material

Constituent 1
Chemical structure
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

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: young and adult rats
- Fasting period before study: 18 hours approx
- Diet (e.g. ad libitum): the food was replaced in cages as soon as animals received their respective doses.
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
other: intubation
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was applied undiluted
Doses:
2330 mg/kg
No. of animals per sex per dose:
10:animals
5 : males
5 : females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs, body weight, mortality
Statistics:
LD50's were computed by the method of Litchfield & Wilcoxon (1949)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 330 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 940 - <= 2 800
Remarks on result:
other: 50% mortality was observed
Mortality:
Mortality were observed in 4hrs-4 days
Clinical signs:
other: Depression, scrawny appearance, tremors with higher doses
Gross pathology:
Necropsy was not conducted
Other findings:
no data available

Any other information on results incl. tables

Acute oral toxicity of food flavourings and compounds of related structure

CAS

Species

LD50 with 95 % confidence limits (mg/kg)

Slope function with 95% confidence limits 

Toxic sign and death time (D.T)

103 -37 -7

Rat

2330 (1940-2800)

1:3 (1.1- 1.6)

Depression, scrawny appearance, tremors with higher doses

D.T. 4hrs-4 days

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be 2330 mg/kg bw (95% confidence limit:1940-2800),when group of 5 male and female Osborne-Mendel rats were treated with test chemical orally.
Executive summary:

Acute oral toxicity study was performed in groups of 10 young adult Osborne-Mendel rats evenly divided by sexusing test chemical at dose concentration of 2330 mg/kg bw.All doses were given by intubation. All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain. The usual observation period was 2 weeks. LD50's were computed by the method of Litchfield & Wilcoxon (1949).The substance was a liquid and it was administered undiluted.50% mortality was observed at dose 2330 mg/kg bw.Clinical signs like somnolence (general depressed activity), Scrawny appearance, tremors at higher doses were observed. Hence,LD50 value was considered to be 2330 mg/kg bw (1940-2800) with 95% confidence limits,when rats were treated withtest chemical orally.