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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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:
Final Report on the Safety Assessment of test chemical
Author:
COSMETIC INGREDIENT REVIEW
Year:
2006
Bibliographic source:
International Journal of Toxicology
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:
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:
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

Materials and methods

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

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:
rabbit
Strain:
other: New Zealand rabbits
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: weighing 1.9 to 2.4 kg

Administration / exposure

Type of coverage:
open
Vehicle:
not specified
Details on dermal exposure:
TEST SITE - Area of exposure: clipped abraded abdominal skin
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days - Frequency of observations and weighing: Observations were made for mortality and toxic effects for 7 days, which was followed by gross necropsy.
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed
Mortality:
No mortality was observed at 2000 mg/kg bw
Clinical signs:
other: At 24 h, rabbits had moderate erythema (10 of 10 rabbits), moderate edema (8 of 10 rabbits), or slight edema (2 of 10 rabbits). On day 7, moderate erythema was observed in 3 of 10 animals and slight erythema was noted in 4 of 10 animals.
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute dermal LD50 value was considered to be >2000 mg/kg bw, when 10 male and female New Zealand rabbits were treated with Thymol (CAS no: 89-83-8) by dermal application to the clipped abraded abdominal skin.
Executive summary:

Acute dermal toxicity study of Thymol (CAS no: 89-83-8) was conducted in 10 male and female New Zealand rabbits at the dose concentration of 2000 mg/kg bw, to the clipped abraded abdominal skin.Observations were made for mortality and toxic effects for 7 days, which was followed by gross necropsy.No mortality was observed at 2000 mg/kg bw. At 24 h, rabbits had moderate erythema (10 of 10 rabbits), moderate edema (8 of 10 rabbits), or slight edema (2 of 10 rabbits). On day 7, moderate erythema was observed in 3 of 10 animals and slight erythema was noted in 4 of 10 animals. Hence LD50 value wasconsidered to be >2000 mg/kg bw, when10 male and female New Zealand rabbits were treated with Thymol (CAS no: 89-83-8) by dermal application to the clipped abraded abdominal skin.