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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 publication.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
I. Acute oral toxicity.
Author:
Jenner et al.
Year:
1964
Bibliographic source:
Food and Cosmetics Toxicology
Reference Type:
publication
Title:
Final Report on the Safety Assessment of test chemical
Author:
COSMETIC INGREDIENT REVIEW
Year:
2006
Bibliographic source:
International Journal of Toxicology
Reference Type:
review article or handbook
Title:
Acute oral toxicity of test chemical
Author:
Richard J. Lewis
Year:
2012
Bibliographic source:
Sax's Dangerous Properties of Industrial Materials
Reference Type:
review article or handbook
Title:
Acute oral toxicity of test substance
Author:
S D Gangolli
Year:
2007
Bibliographic source:
The Dictionary of Substances and their Effects (DOSE): T-Z and Index
Reference Type:
review article or handbook
Title:
oral toxicity of test chemical
Author:
Michael Ash
Year:
2004
Bibliographic source:
Handbook of Green Chemicals
Reference Type:
review article or handbook
Title:
Acute oral toxicity - Test chemical
Author:
Kirk-Othmer
Year:
2012
Bibliographic source:
Kirk-Othmer Chemical Technology of Cosmetics
Reference Type:
review article or handbook
Title:
Acute oral toxicity in rat by using test chemical
Author:
Victor O. Sheftel
Year:
2000
Bibliographic source:
Indirect Food Additives and Polymers
Reference Type:
review article or handbook
Title:
Acute oral toxicity:Test chemical
Author:
Maryadele J ‘O Neil
Year:
2006
Bibliographic source:
Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals
Reference Type:
other: authoritative database
Title:
Acute oral toxicity in rat.
Author:
U.S. National Library of Medicine
Year:
2017
Bibliographic source:
ChemIDplus
Reference Type:
other: authoritative database
Title:
Acute toxicity - test chemical
Author:
IFA GESTIS
Year:
2018
Bibliographic source:
GESTIS database
Reference Type:
other: authoritative database
Title:
Acute toxicity : Test Chemical
Author:
U.S. National Library of Medicine
Year:
2015
Bibliographic source:
HSDB
Reference Type:
review article or handbook
Title:
Acute Oral Toxicity : Test substance
Author:
Council of Europe
Year:
2006
Bibliographic source:
Plants in cosmetics
Reference Type:
secondary source
Title:
Acute oral toxicity of test chemical conducted in rat
Author:
RTECS
Year:
2017
Bibliographic source:
RTECS
Reference Type:
secondary source
Title:
Test substance used to determine acute toxicity
Author:
U.S. National Library of Medicine
Year:
2017
Bibliographic source:
TOXNET
Reference Type:
secondary source
Title:
BIOPESTICIDE REGISTRATION ACTION DOCUMENT
Author:
U.S. Environmental Protection Agency
Year:
2006
Bibliographic source:
U.S. Environmental Protection Agency
Reference Type:
secondary source
Title:
Conclusion on the peer review of the pesticide risk assessment of the active substance
Author:
EFSA
Year:
2012
Bibliographic source:
EFSA Journal
Reference Type:
secondary source
Title:
Test chemical: Reregistration Eligibility Decision (RED)
Author:
U. S. Environmental Protection Agency (EPA)
Year:
1993
Bibliographic source:
U. S. Environmental Protection Agency (EPA)
Reference Type:
secondary source
Title:
DAR - test chemical
Author:
European Food Safety Agency (EFSA)
Year:
2011
Bibliographic source:
European Food Safety Agency
Reference Type:
secondary source
Title:
Phenols in Flavor Usage
Author:
Food and Drug Administration
Year:
1985
Bibliographic source:
National Technical Information Service
Reference Type:
secondary source
Title:
Up to date review of toxicological data of some plant volatiles with antifungal activity
Author:
Food and Drug Administration
Year:
1999
Bibliographic source:
National Technical Information Service

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Acute oral toxicity of Thymol (CAS no: 89-83-8) in rat.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Thymol
EC Number:
201-944-8
EC Name:
Thymol
Cas Number:
89-83-8
Molecular formula:
C10H14O
IUPAC Name:
5-methyl-2-(propan-2-yl)phenol
Details on test material:
- IUPAC Name: Thymol- InChI: 1S/C10H14O/c1-7(2)9-5-4-8(3)6-10(9)11/h4-7,11H,1-3H3- Smiles: c1(c(cc(C)cc1)O)C(C)C- Molecular formula :C10H14O- Molecular weight :150.2196 g/mol- Substance type:Organic- Physical state:Solid, white crystalline powder, thyme-like, aromatic odor
Specific details on test material used for the study:
- IUPAC Name: Thymol- InChI: 1S/C10H14O/c1-7(2)9-5-4-8(3)6-10(9)11/h4-7,11H,1-3H3- Smiles: c1(c(cc(C)cc1)O)C(C)C- Molecular formula :C10H14O- Molecular weight :150.2196 g/mol- Substance type:Organic- Physical state:Solid, white crystalline powder, thyme-like, aromatic odor

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Fasting period before study: fasted for approximately 18 hr prior to treatment

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE- Concentration in vehicle: 20%
Doses:
980 (817-1180)mg/kg bw
No. of animals per sex per dose:
groups of 5/sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: Animals were observed for one or two weeks for clinical signs and body weight effects.
Statistics:
LD50’s were computed by the method of Litchfield & Wilcoxon (1949).

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
980 mg/kg bw
Based on:
test mat.
95% CL:
817 - 1 180
Remarks on result:
other: 50% mortality observed
Mortality:
Rats died within 4 h to 5 days after dosing
Clinical signs:
other: Depression and ataxia were noted in most dose groups and coma at greater doses.
Gross pathology:
not specified
Other findings:
not specified

Any other information on results incl. tables

Table - Acute oral toxicity of food flavourings and compounds of related structure:

Compound

Concentration

(w/v) and

solvent

used

Species

LD50 with

95 % confidence limits

(mg/kg

Slope function with 95% confidence

limits

Toxic signs and death

time (D.T.)

Thymol

(p-cymen-3-ol,3-

Hydroxyl-p-cymene)

C - 20%

Rat

980

(817-1180)

1.6

(1.3-2.0)

Depression, ataxia, coma on high

doses

D.T. 4 hr-5 days

 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral LD50 value was considered to be 980 mg/kg (with 95% confidence limits of 817 to 1180 mg/kg), when groups of 5 male and female Osborne-Mendel rats were treated with Thymol (CAS no: 89-83-8) via oral gavage route.
Executive summary:

Acute oral toxicity study of Thymol (CAS no: 89-83-8) was conducted in groups of 5 male and female Osborne-Mendel rats at the dose concentration of 980 (817-1180) mg/kg bw. The given test chemical dissolved at 20% in propylene glycol and administered via oral gavage route. Animals were observed for one or two weeks for clinical signs and body weight effects. LD50’s were computed by the method of Litchfield & Wilcoxon (1949). Rats died within 4 h to 5 days after dosing. Depression and ataxia were noted in most dose groups and coma at greater doses. Therefore, LD50 was considered to be 980 mg/kg (with 95% confidence limits of 817 to 1180 mg/kg), when groups of 5 male and female Osborne-Mendel rats were treated with Thymol via oral gavage route.