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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:
D. McGinty et. al.
Year:
2012
Bibliographic source:
Food and Chemical Toxicology,2012
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 study of benzyl isobutyrate (103-28-6) in rat
Author:
U.S. National Library of Medicine
Year:
2018
Bibliographic source:
Chemidplus Database,U.S. National Library of Medicine,2018
Reference Type:
review article or handbook
Title:
Dictionary of Food Compounds with CD-ROM, Second Edition
Author:
Shmuel Yannai
Year:
2012
Bibliographic source:
Dictionary of Food Compounds with CD-ROM, Second Edition, CRC Press, page number 1334,23-Oct-2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity of test chemical was determined in rats.
GLP compliance:
not specified
Test type:
other: No data
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl isobutyrate
EC Number:
203-095-9
EC Name:
Benzyl isobutyrate
Cas Number:
103-28-6
Molecular formula:
C11H14O2
IUPAC Name:
benzyl 2-methylpropanoate
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Benzyl isobutyrate
- Molecular formula (if other than submission substance): C11H14O2
- Molecular weight (if other than submission substance): 178.23 g/mole
- Substance type: Organic
- Physical state: Liquid

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: gavage
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
2510, 3160, 3980 and 5000 mg/kg
No. of animals per sex per dose:
Total:40
2510 mg/kg bw: 5 male, 5 female
3160 mg/kg bw: 5 male, 5 female
3980 mg/kg bw: 5 male, 5 female
5000 mg/kg bw: 5 male, 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and gross pathology were observed.
Statistics:
No data available

Results and discussion

Preliminary study:
In preliminary studies, dose levels of 316, 1260 and 5000 mg/kg resulted in mortality in 0/2, 0/2 and 2/2 rats from low to high dose.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 850 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 252 - <= 3 608
Remarks on result:
other: No effect on survival, clinical sign and gross pathology
Mortality:
When treated with 5000 mg/kg bw, all animals were died, at 3980 mg/kg bw, 9 animals were died, at 3160 mg/kg bw, 6 animals were died and at 2510 mg/kg 4 animals were died.
Clinical signs:
other: sedation and tremors were observed in treated rats.
Gross pathology:
No gross pathological alterations were observed in treated male and female rats at necropsy.
Other findings:
No data available

Any other information on results incl. tables

Dose (mg/kg)

Mortality / number of animals treated

 2510

4/10

3160

6/10

3980

9/10

5000

10/10

Summary of acute toxicity studies

Route

Species

NO. animals/dose group

LD50 (g/kg)

Oral

Rat

10

2.85

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
Therefore, LD50 was considered to be 2850 mg/kg bw (2252-3608 mg/kg) when male and female rats were treated with test chemical orally by gavage.
Executive summary:

Ina acute oral toxicity study, male and female rats were treated with test chemical in the concentration of 2510, 3160, 3980 or 5000 mg/kg orally by gavage and observed for 14 days. In preliminary studies, dose levels of 316, 1260 and 5000 mg/kg resulted in mortality in 0/2, 0/2 and 2/2 rats from low to high dose. In main study, all animals were died at 5000 mg/kg bw, 9 animals died at 3980 mg/kg bw, 6 animals died at 3160 mg/kg bw and 4 animals died at 2510 mg/kg. Sedation and tremors were observed in treated rats. No gross pathological alterations were observed in treated male and female rats at necropsy. Therefore, LD50 was considered to be 2850 mg/kg bw (2252-3608 mg/kg) when male and female rats were treated with test chemical orally by gavage.

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